BUSINESS DEVELOPMENT MANAGER ( position filled)

 

Are you a Business Development professional and do you consider yourself an entrepreneur,  teampleayer and innovator? Than you could be the Perfect Match for a vacancy with one of our clients.

We are looking for an ambtious Business Development Manager who loves a good challenges and is eager to contribute to growth and innovation of an exciting young company.

Being a Business Development Manager with our client calls for an individual who demonstrates a solid experience within Business Development. You have a natural talent for sales, and you see and think in opportunities. You change opportunities in sales.

 

JOB PROFILE

As the number of participating trial centers and oncologists grows, our client will increasingly be used for the entire study start up and patient recruitment process. Their approach:

Build up a database of and relationship with potential clients (pharma, biotech, research groups, study network organizations and CROs)

Present client solutions via traditional and innovative means of communication

Closing the deal by proposal writing, negotiation and reporting

Work closely together with client’s Hospital and Trial Liaisons who are implementing the trials and will find and/or communicate new business opportunities

Be open minded, innovative, self-motivated and driven to achieve personal and company success of our client!

 

EXPERIENCE

• A large dose of Self-Knowledge, Pro-activity and Self-Management
• Enormous perseverance
• A well-organized and self-motivated character, comfortable working autonomously
• Experience in business innovation and change management
• Experience in selling online services
• An outstanding communicator, able to deliver a killer pitch to 1-40 people
• Excellent listening and negotiation skills and a natural deal closer
• Knowledge of hospital clinical trial organizations/structures/people preferred
• Oncology study experience preferred

 

JOB REQUIREMENTS:

• 3-4 years work experience within Business Development, preferably within a CRO and/or pharmaceutical industry or research groups
• Bachelor’s degree or equivalent supplemented with Business Administration, Management (sales/business development/project management) degrees proven training and interest
• IT & Innovation enthusiasm!
• The guts to challenge and build new opportunities
• Feel comfortable in a startup organization
• Willing and able to travel internationally

 

WHAT OUR CLIENT OFFERS:

• Make a true difference in patients’ lives by increasing access for patients to innovative medicine in clinical trials and speeding up the drug development processes
• Being part of a small team that scales a startup company to a global enterprise

Interested? Contact us via mail: office@schmidtconsultancy.nl or phone 0575-441001. We look forward to get in touch with you!

CLINICAL STUDY LEAD ( min 0,8 fte; located in Belgium or the Netherlands) – on hold

 

JOB PROFILE:

As  a member of the Clinical Operations Department you will support the Development team in contributing to the clinical evaluation of new drug candidates through the operational management, and timely execution and delivery of clinical studies.

 

MAIN RESPONSIBILITIES:

• Appropriately plan allocated stud(y)/(ies) in terms of budget, resources and timelines.
• Execute and deliver on allocated clinical stud(y)/(ies) from initial planning, setup and conduct until final reporting of results within agreed budget, timelines and with high quality.
• Initiate and coordinate the vendor selection process.
• Be the primary contact person for selected vendors and ensure high quality oversight of performance in accordance with agreed study plans, timelines & budget.
• Build a sound relationship with the key vendor and site staff in charge of the execution of allocated stud(y)/(ies).
• Develop the Clinical Study Oversight Plan and ensure that oversight activities are performed and documented accordingly.
• Monitor budget/timelines and provide accurate forecasting
• Monitor quality and progress of allocated stud(y)/(ies) versus agreed quality standards, budget and timelines. Flag variances to COPL and direct line management.
• Report status of allocated stud(y)/(ies) as required.
• Coordinate the timely creation of, review and/or approve study documents and plans.
• Ensure proper and timely set-up, maintenance, review (i.e. Quality checks) and archiving of the Trial Master File.
• Internal primary point of contact for assigned clinical stud(y)/(ies), close interaction with Clinical Study Team (CST) members.
• Build sound cross-functional relationships with relevant staff from the Project Team (PT), Clinical Development Team (CDT) and with all CST members.
• Organize and lead cross-functional Internal CST-Meetings and prepare, attend and follow-up on vendor meetings.
• Ad hoc, act as CST representative in the CDT.
• Interact with the Quality Monitor and follow-up on audit reports. Ensure timely creation of CAPA-plan and timely CAPA closure.
• Comply with GLPG procedures and processes, ICH-GCP and applicable regulations and guidelines.
• Actively initiate and participate in Process Improvement initiatives.
• Participate in/present at team and departmental meetings
• Participate in/present at Committee meetings (Protocol Review Committee (PRC), Management Review Committee (MRC), Development Management Committee (DMC)), as required.
• Specific accountabilities for Early Development studies:
  • Act as representative for Clinical Operations in the joint PT/CDT when relevant for the set-up of a study concept of an Early Development study.
  • Take part and provide operational input in Focused Clinical Team meetings where details on the study design of an Early Development study are being discussed.
  • Ensure a budget and timelines are allocated to a newly planned Early Development study in the GLPG project management system as required.

 

JOB REQUIREMENTS

The ideal candidate has:

• Academic level of education, preferably in the biomedical field;The ideal candidate has:Academic level of education, preferably in the biomedical field;
  Several years of experience with Clinical Trials in the pharmaceutical and/or CRO industry
  Preferably a minimum of 3 years experience as a Project Manager;
  Extensive multi-national study experience;
  Excellent command of written and spoken English and preferably also Dutch;
  Excellent knowledge of legislation and regulations and ICH-GCP guidelines.

Furthermore we are looking for a candidate with the following well developed skills and competences:

Analytical and social skills and flexibility;
Accuracy, self-motivating, self-starting, decisive with minimal supervision;
Ability to work on several projects, retaining timelines and quality;
The competences related to this function are: ownership, impact, overview, vendor management, leadership, style flexibility, organizational sensitivity and financial awareness.

 

COMPANY CULTURE

The company culture of our client can best be described as  non hierarchic, dynamic, open, co-operative, motivational, collegial, and inspirational. But also ambitious, looking for professionals with a pioneer mindset of continuous scientific exploration, risk-taking, and speed of action for the benefit of patients.

They set clear goals, work hard to attain them, and celebrate their successes.

Interested? Contact us via mail: office@schmidtconsultancy.nl or phone 0575-441001. We look forward to get in touch with you!

SENIOR CLINICAL PROJECT MANAGER ( min 0,8 fte); located in Europe

For one of our clients, we are looking for a self-starting, independently working Senior Clinical Project Manager with a broad skill set to join the Project Management Team in the planning and execution of projects within scope and budget and compliant with ICH-GCP guidelines, protocol and SOPs.

As part of the Project Management Team (12 people), you will directly report to a Project Director. 

 

TASKS AND RESPONSIBILITIES

You will:

• Start up and manage clinical projects which are complex in terms of design, scope of services and scale in accordance with all relevant guidelines, legislation and SOPs;
• Develop study-specific documentation (in cooperation with the Compliance department);
• Maintain oversight and manage the progress of the clinical project against the project plan and previously defined performance indicators in terms of quality, quantity and budget and adjusts implementation as necessary;
• Be able to have effective discussions with customers to resolve study complex or high impact study challenges;
• Ensures a robust risk management plan is in place and collaborates closely with the overseeing PD to ensure all relevant stake holders are involved and held accountable;
• Report the progress made to the sponsor, the next level internally, the MT and the study’s Steering Committee (if applicable);
• Act-as day-to-day point of contact for the sponsor and for other PMs as assigned to the project;
• Initiate process improvements, e.g. professionalization of work activities, methods of reporting, implementation of new legislation and regulations;
• Accountable for the project finances in accordance with the customer contract and the budget;
• Provide input to proposals and budgets and play a role in bid defense meetings.

 

JOB REQUIREMENTS

The ideal candidate has:

• Academic level of education, preferably in the biomedical field;
• A minimum of 6 years’ experience with Clinical Trials in the pharmaceutical and/or CRO industry and CRO experience is preferable;
• Preferably a minimum of 3 years experience as a Project Manager;
• Extensive multi-national study experience;
• Excellent command of written and spoken English and preferably also Dutch;
• Excellent knowledge of legislation and regulations and ICH-GCP guidelines.

 

Furthermore we are looking for a candidate with the following well developed skills and competences:

• Analytical and social skills and flexibility;
• Accuracy, self-motivating, self-starting, decisive with minimal supervision;
• Ability to work on several projects, retaining timelines and quality;
• The competences related to this function are: ownership, impact, overview, customer orientation, leadership, style flexibility, organizational sensitivity and financial awareness.

 

COMPANY CULTURE

The company culture of our client can best be described as dynamic, open, co-operative, motivational, collegial, and inspirational. They set clear goals, work hard to attain them, and celebrate their successes.

Interested? Contact us via mail: office@schmidtconsultancy.nl or phone 0575-441001. We look forward to get in touch with you!

STUDY START-UP PROJECT MANAGER ( min 0,8 fte)

Due to growh at one of our clients, we are looking for a Study Start-Up Project Manager with a broad skill set to join the Project Management Team in the planning and execution of projects within scope and budget and compliant with ICH-GCP guidelines, protocol and SOPs.

You will be based at the headquarters of our client in the Netherlands or will work remotely anywhere in Europe. As part of the Project Management Team (18 people), you will directly report to a (Associate) Project Director ( PD).

 

TASKS AND RESPONSIBILITIES

You will:

Lead the cross-functional team during the study start-up phase liaising directly with the Project Manager, core team members, local regulatory experts and the client;

Serve as client’s contact for start-up processes and oversight;

Monitor and control start up project schedule, budget, and scope;

Proactively engage in both quality assurance and risk management planning activities to ensure project deliverables are met.

Initiate improvements to enhance the efficiency and the quality of the start-up work performed on assigned projects;

Develop study-specific documentation (in cooperation with the Compliance Department);

Report the progress made to the sponsor, the next level internally, and the Management Team;

Provide input to proposals and budgets and play a role in bid defense meetings.

 

JOB REQUIREMENTS

The ideal candidate has:

An academic level of education, preferably in the biomedical field;

A minimum of 6 years’ experience with Clinical Trials in the pharmaceutical and/or CRO industry; CRO experience is preferable;

Preferably a minimum of 3 years’ experience as a Start-Up Lead or Project Manager;

Extensive multi-national study experience;

Excellent command of written and spoken English;

Excellent knowledge of legislation and regulations and ICH-GCP guidelines.

 

Furthermore, we are looking for a candidate with the following well developed skills and competences:

Analytical and social skills and flexibility;

Accuracy, self-motivating, self-starting, decisive with minimal supervision;

Ability to work on several projects, retaining timelines and quality;

The competences related to this function are: ownership, impact, overview, customer orientation, leadership, style flexibility, organizational sensitivity and financial awareness.

 

COMPANY CULTURE

The company culture of our client can best be described as dynamic, open, co-operative, motivational, collegial, and inspirational. They set clear goals, work hard to attain them, and celebrate their successes.

Interested? Contact us via mail: office@schmidtconsultancy.nl or phone 0575-441001. We look forward to get in touch with you!

CLINICAL PROJECT MANAGER ( min 0,8 fte); located in Europe

Due to growh at one of our clients, we are looking for a Project Manager with a broad skill set to join the Project Management Team in the planning and execution of projects within scope and budget and compliant with ICH-GCP guidelines, protocol and SOPs. We welcome both junior and senior Project Managers.

You will be based at the headquarters of our client in the Netherlands or will work remotely anywhere in Europe. As part of the Project Management Team (18 people), you will directly report to a Project Director ( PD).

 

TASKS AND RESPONSIBILITIES
You will

• Start up and manage clinical projects (which are complex in terms of design, scope of services and scale) in accordance with all relevant guidelines, legislation and SOPs;
• Develop study-specific documentation (in cooperation with the Compliance Department);
• Monitor and manage the progress of the clinical project against the project plan and previously defined performance indicators in terms of quality, quantity and budget and adjusts implementation as necessary;
• Identify risks and develop and execute plans to mitigate risk in collaboration with key team members;
• Report the progress made to the sponsor, the next level internally, the Management Team and the study’s Steering Committee (if applicable);
• (May) Act-as day-to-day point of contact for the sponsor and for other PMs as assigned to the project;
• Contribute or initiate process improvements, e.g. professionalization of work activities, methods of reporting, implementation of new legislation and regulations;
• Manage or is accountable for the project finances in accordance with the customer contract and budget;
• Provide input to proposals and budgets and play a role in bid defense meetings.

 

At a more senior level you will also:

• Be able to have effective discussions with customers to resolve study complex or high impact study challenges;
• Ensure a robust risk management plan is in place and collaborate closely with the overseeing PD to ensure all relevant stake holders are involved and held accountable.

 

JOB REQUIREMENTS
The ideal candidate has

• An academic level of education, preferably in the biomedical field;
• A minimum of 4 years’ experience with Clinical Trials in the pharmaceutical and/or CRO industry; CRO experience is preferable;
• Preferably a minimum of 2 years’ experience as a (junior) Project Manager;
• Extensive multi-national study experience (for a more senior level);
• Excellent command of written and spoken English;
• Excellent knowledge of legislation and regulations and ICH-GCP guidelines.

Furthermore we are looking for a candidate with the following well developed skills and competences:

• Analytical and social skills and flexibility;
• Accuracy, self-motivating, self-starting, decisive with minimal supervision;
• Ability to work on several projects, retaining timelines and quality;

The competences related to this function are: ownership, impact, overview, customer orientation, leadership, style flexibility, organizational sensitivity and financial awareness

 

COMPANY CULTURE

The company culture of our client can best be described as dynamic, open, co-operative, motivational, collegial, and inspirational. They set clear goals, work hard to attain them, and celebrate their successes.

Interested? Contact us via mail: office@schmidtconsultancy.nl or phone 0575-441001. We look forward to get in touch with you!

SENIOR CLINICAL PROJECT MANAGER ( min 0,8 fte); located in Europe

For one of our clients, we are looking for a self-starting, independently working Senior Clinical Project Manager with a broad skill set to join the Project Management Team in the planning and execution of projects within scope and budget and compliant with ICH-GCP guidelines, protocol and SOPs.

As part of the Project Management Team (12 people), you will directly report to a Project Director. 

 

TASKS AND RESPONSIBILITIES

You will:

• Start up and manage clinical projects which are complex in terms of design, scope of services and scale in accordance with all relevant guidelines, legislation and SOPs;
• Develop study-specific documentation (in cooperation with the Compliance department);
• Maintain oversight and manage the progress of the clinical project against the project plan and previously defined performance indicators in terms of quality, quantity and budget and adjusts implementation as necessary;
• Be able to have effective discussions with customers to resolve study complex or high impact study challenges;
• Ensures a robust risk management plan is in place and collaborates closely with the overseeing PD to ensure all relevant stake holders are involved and held accountable;
• Report the progress made to the sponsor, the next level internally, the MT and the study’s Steering Committee (if applicable);
• Act-as day-to-day point of contact for the sponsor and for other PMs as assigned to the project;
• Initiate process improvements, e.g. professionalization of work activities, methods of reporting, implementation of new legislation and regulations;
• Accountable for the project finances in accordance with the customer contract and the budget;
• Provide input to proposals and budgets and play a role in bid defense meetings.

 

JOB REQUIREMENTS

The ideal candidate has:

• Academic level of education, preferably in the biomedical field;
• A minimum of 6 years’ experience with Clinical Trials in the pharmaceutical and/or CRO industry and CRO experience is preferable;
• Preferably a minimum of 3 years experience as a Project Manager;
• Extensive multi-national study experience;
• Excellent command of written and spoken English and preferably also Dutch;
• Excellent knowledge of legislation and regulations and ICH-GCP guidelines.

 

Furthermore we are looking for a candidate with the following well developed skills and competences:

• Analytical and social skills and flexibility;
• Accuracy, self-motivating, self-starting, decisive with minimal supervision;
• Ability to work on several projects, retaining timelines and quality;
• The competences related to this function are: ownership, impact, overview, customer orientation, leadership, style flexibility, organizational sensitivity and financial awareness.

 

COMPANY CULTURE

The company culture of our client can best be described as dynamic, open, co-operative, motivational, collegial, and inspirational. They set clear goals, work hard to attain them, and celebrate their successes.

Interested? Contact us via mail: office@schmidtconsultancy.nl or phone 0575-441001. We look forward to get in touch with you!

SENIOR CLINICAL PROJECT MANAGER ( min 0,8 fte); located in Europe

For one of our clients, we are looking for a self-starting, independently working Senior Clinical Project Manager with a broad skill set to join the Project Management Team in the planning and execution of projects within scope and budget and compliant with ICH-GCP guidelines, protocol and SOPs.

As part of the Project Management Team (12 people), you will directly report to a Project Director. 

 

TASKS AND RESPONSIBILITIES

You will:

• Start up and manage clinical projects which are complex in terms of design, scope of services and scale in accordance with all relevant guidelines, legislation and SOPs;
• Develop study-specific documentation (in cooperation with the Compliance department);
• Maintain oversight and manage the progress of the clinical project against the project plan and previously defined performance indicators in terms of quality, quantity and budget and adjusts implementation as necessary;
• Be able to have effective discussions with customers to resolve study complex or high impact study challenges;
• Ensures a robust risk management plan is in place and collaborates closely with the overseeing PD to ensure all relevant stake holders are involved and held accountable;
• Report the progress made to the sponsor, the next level internally, the MT and the study’s Steering Committee (if applicable);
• Act-as day-to-day point of contact for the sponsor and for other PMs as assigned to the project;
• Initiate process improvements, e.g. professionalization of work activities, methods of reporting, implementation of new legislation and regulations;
• Accountable for the project finances in accordance with the customer contract and the budget;
• Provide input to proposals and budgets and play a role in bid defense meetings.

 

JOB REQUIREMENTS

The ideal candidate has:

• Academic level of education, preferably in the biomedical field;
• A minimum of 6 years’ experience with Clinical Trials in the pharmaceutical and/or CRO industry and CRO experience is preferable;
• Preferably a minimum of 3 years experience as a Project Manager;
• Extensive multi-national study experience;
• Excellent command of written and spoken English and preferably also Dutch;
• Excellent knowledge of legislation and regulations and ICH-GCP guidelines.

 

Furthermore we are looking for a candidate with the following well developed skills and competences:

• Analytical and social skills and flexibility;
• Accuracy, self-motivating, self-starting, decisive with minimal supervision;
• Ability to work on several projects, retaining timelines and quality;
• The competences related to this function are: ownership, impact, overview, customer orientation, leadership, style flexibility, organizational sensitivity and financial awareness.

 

COMPANY CULTURE

The company culture of our client can best be described as dynamic, open, co-operative, motivational, collegial, and inspirational. They set clear goals, work hard to attain them, and celebrate their successes.

Interested? Contact us via mail: office@schmidtconsultancy.nl or phone 0575-441001. We look forward to get in touch with you!

PROJECT DIRECTOR (0,8-1 FTE; LOCATED IN WEST OR CENTRAL EUROPE)

Are you an experienced Project Director or do you have senior clinical project management experience and are you looking for the next step in your career? Than this might be the opportunity you are looking for!

For one of our clients we are looking for a proactive and entrepreneurial Project Director with strong communication skills, line management and full-service experience.  Experience or affinity with Infectious Disease and Immunology is preferred and experience with SMO trials and / or Real World Evidence experience is welcome as well. You will be responsible for overseeing (international) industry driven studies in Infectious Disease and Immunology with a high and challenging profile with key clients. The key clients vary from biotech start-ups to large pharma.

 

JOB PROFILE

As Project Director have a diverse and dynamic set of responsibilities. Acting at the crossroads of academic research and trials for biopharmaceutical companies you’ll be an important player in securing new business and overseeing the delivery of these projects. Our client prides itself in being able to deliver full service clinical trials but doing so in close collaboration with their scientific collaborators. As Project Director you provide strategic direction, leadership and management across multiple divisions to direct the delivery of projects/programs within cost, time and quality requirements. You provide direct supervision, support, training and mentoring to a staff of Project Managers.

Our client has a demonstrated track record to prove that by bringing science and operations close together they motivate their sites to perform better and to find creative solutions to the challenges that many clinical trials pose.

You will have line management responsibility for a team of project managers and be an active member in Therapeutic Expert Teams which bring together operations, science and business development.

 

JOB REQUIREMENTS

• Academic level of education in biomedical sciences;
• A minimum of 10 years of progressive experience in life sciences, including 5 years of experience in a project management position in the biopharmaceutical industry;
• A minimum of 3 years of CRO experience;
• Strong communication skills;
• Extensive experience with management of multinational/ international clinical trials;
• Proficiency in working with complex design issues (e.g., multiple arms, crossover, double blind, and multi-center) in all phases of pre-approval clinical trials;
• Experience with contributing to proposals, budgets and Bid Defense Meetings for new opportunities;
• Experience with financial planning.

 

JOB OFFER

An open culture in an innovative and dynamic environment with inspiring colleagues and good working conditions. An environment where you have room to be creative, take initiative and have direct influence on the way we work.

Employees have the flexibility to work from home or from the office or a combination of the two. The Project Director can be located anywhere in West or Central Europe.

Interested? Contact us via mail: office@schmidtconsultancy.nl or phone 0575-441001. We look forward to get in touch with you!

PROJECT COMPLIANCE MANAGER ( min. 0,8 fte); located in the Netherlands

 

JOB OVERVIEW

Are you an experienced CRA, CTL or associate Project Manager with a passion for processes and training? Then we are looking for you!

Working as a Project Compliance Manager means every day is different. The one day you are developing processes, the other you are creating a tool or a training-program for CRA’s. Whether you are creating a monitoring manual, organizing an investigator meeting, answering questions about last week’s training program or training CRA’s; one thing is for sure, you are constantly interacting with people in- and outside the organization of our client. You will deal with different stakeholders throughout the organization and will answer questions from every corner of the organization. You will work at the same time on different (international) clinical trials, in different therapeutic areas and in different phases. Each study requires its own approach, which makes the job very interesting and challenging.

As Project Compliance Manager you will ensure compliance with the company quality requirements and standards by providing compliance management of clinical trial processes, tools, reports and systems across assigned trials. The job asks you to perform in a calm, inspirational and collected way during demanding, challenging circumstances.

 

TASKS AND RESPONSIBILITIES

Depending of your working experience and skills, you will be more or less supportive in the following tasks/ responsibilities:

• Develop standardized clinical trial processes for assigned clinical trials as defined in the scope of work (e.g. monitoring manual, roadmaps, forms and templates, etc.);
• Ensure implementation of the clinical trial processes with all parties (including sponsor) involved in the clinical trial by means of training;
• Participate in developing, maintaining and improving the clinical trial processes as required;
• Act as the primary contact for escalation of any issues with procedures by the involved parties and sponsor;
• Review clinical trial processes proposed by 3rd parties for compliance and practical issues and contribute to risk analysis;
• Initiate updates of written clinical trial processes (e.g. monitoring manual, roadmaps, forms and templates, etc.);
• Develop, plan and execute compliance checks on clinical trial processes in accordance with the project specific compliance management plan;
• Analyze the findings of the project specific compliance checks for relevance across the assigned clinical trial.

 

JOB REQUIREMENTS

• Higher level of education in a (bio)medical field;
• Basic knowledge of legislation and regulations, clinical processes, industry practices and ICH-GCP and guidelines;
• A minimum of 3 years of experience as a Clinical Research Associate, Clinical Team Lead or (associate) Project Manager;
• Experience with working (on site) in international clinical trials is preferable;
• Experience in and passion for training/instruction and harmonising clinical project processes is preferable;
• Adequate command of English (in speech and writing) and preferably also in Dutch;
• Creative /out of the box approach; multitasking, flexible, stress resistant and good overview skills.

 

Our client offers:

• The company culture of our client can best be described as dynamic, open, co-operative, motivational, collegial, and inspirational.
• They set clear goals, work hard to attain them, and celebrate their successes.
• Training and support to become a specialist in compliance and develop personal and professional skills.
• You will be trained on the job and they will guide you well at the start by for example assign you a buddy and an onboarding program.

 

Interested? Contact us via mail: office@schmidtconsultancy.nl or phone 0575-441001. We look forward to get in touch with you!

Position filled

For one of out clients, we are looking for a communicative, proactive and independently working Data Manager who likes a good challenge. The Data Management team is a part of the Clinical Operations Department. The team consists of a Manager Data Management, 1 senior Data Manager, 1 Data Manager, 3 junior Data Managers and a Statistical Officer. The Clinical Data Manager will be reporting to the Manager Data Management. If you like variation and differentation in your CDM role and to be encouraged to share your ideas to the further development of the department, this could be the perfect next step in your career . The CDM represents data management in the study team of clinical research projects possibly in diverse therapeutic areas, ensures that all data management activities are performed with high quality from the start of the study. The CDA also represents the team within the company (cross team) and if necessary also has contact with external parties.

 

TASKS AND RESPONSIBILITIES

The CDM will:

• Represent Data Management in (internal) study teams and within the company;
• Depending on experience level, the CDM coaches and supports Junior Data Manager(s) and other (project) Data Managers on project related tasks;
• Serve as point of contact for external parties such as vendor(s) for Central Laboratory or Investigational Medicinal Product (IMP) vendor and sponsor(s);
• Designs, manages and delivers – in collaboration with an external party- a clinical database within the agreed timeframes according to all relevant quality standards;
• Organize data capture, quality and management processes to safeguard study data integrity and quality in full accordance with the Standard Operating Procedures ánd international laws and guidelines;
• Keep oversight on relevant Data Management activities within a project, as specified in the Data Management Plan;
• Organise and distribute study data to facilitate statistical analysis and reporting;
• Contribute to process improvements, e.g. professionalization of work activities, methods of working, implementation of new legislation and regulations.
• Support or even ensure the implementation of the latest Data Quality requirements to the clinical trial processes, including to business processes;
• Assist the IT department in validating the computerized clinical study management systems;
• Provide input for Data management services cost proposal.

 

JOB REQUIREMENTS

• Higher level of education preferably in (bio)medical, scientific or computer science;
• At least 1 year of relevant experience, preferably within the Food, Health or Clinical Research sector;

 

COMPANY CULTURE

• An open culture in an innovative and dynamic environment with inspiring colleagues and good working conditions;
• An environment where you have room to be creative, take initiative and have direct influence on the way we work;
• Good opportunities for (personal) growth and further development.

 

Interested? Contact us via mail: office@schmidtconsultancy.nl or phone 0575-441001. We look forward to get in touch with you.

CLINICAL TEAM LEAD; 0,8-1 fte

 

For one of our clients we are actively looking for a Clinical Team Lead (CTL) who manages clinical monitoring and site management activities in one or more countries. The CTL also provides training and coaching for the CRA teams in the assigned countries with regard to protocol, Case Report Forms and study-specific procedures.

The CTL will be involved in one or more (international) studies. The CTL can either work as singular CTL on a study, or in larger studies, as part of an (international) team of CTLs. The current CTL team consists of 7 CTLs, with whom knowledge and experiences are shared on a regular basis.

 

TASKS AND RESPONSIBILITIES

• Manages the clinical activities in the assigned countries in accordance with previously defined performance indicators in terms of both quality and quantity and implements actions as necessary
• Monitors the clinical activities in accordance with protocol, SOPs, applicable laws and ICH-GCP guidelines
• Ensures that information is conveyed effectively between the sponsor, Project Manager and the CRA team
• Ensures adherence of the CRA team to study timelines
• Reviews monitoring visit reports
• Performs accompanied site visits
• Contributes to the development of study-specific documentation
• Trains CRAs with regard to protocol, Case Report Form (CRF) and study-specific procedures
• Participates in, and jointly organises meetings for investigators and CRAs
• Ensures the correct query process is followed in collaboration with Data Management
• Ensures the correct reporting and follow-up of Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions
• Supports the CRA team during inspections by healthcare authorities or audits
• Ensures the reliable documentation and archiving of study documents, both at the study site and ‘in-house’.

DESIRED SKILLS AND EXPERTISE

• Higher level of education preferably in a (bio)medical field
• A minimum of 3 years’ experience as CRA in the pharmaceutical and/or CRO industry
• Work experience as a Clinical Team Lead or a simular position is an advantage
• Up-to-date knowledge of legislation and regulations and ICH/GCP guidelines
• Experience with multi-centre, international studies
• Adequate command of written and spoken Dutch and English.

COMPANY CULTURE

The company culture of our client can best be described as dynamic, open, co-operative, motivational, collegial, and inspirational. We set clear goals, work hard to attain them, and celebrate our successes. Good working conditions.

 

Interested? Contact us via mail: office@schmidtconsultancy.nl or phone 0575-441001. We look forward to get in touch with you.

CLINICAL RESEARCH ASSOCIATE (CRA), at least 2 years experience; 0,8 – 1 fte

 

Do you like to coordinate and monitor (inter)national, multicentre clinical trials in order to assure the quality of the clinical data? Then this could be the opportunity to develop your career! For one of our clients we are looking for talented and proactive Clinical Research Associates with strong communication and negotiation skills and with willingness to travel (Corona proof) on an irregular base.

You will be part of the CRA team, currently existing of thirteen (13) CRA’s, and you will report to the Manager Clinical Monitoring.

 

TASKS AND RESPONSIBILITIES

• Monitors clinical research in accordance with the protocol, SOPs, applicable laws and ICH-GCP guidelines, including visit report compilation and follow-up within the set timelines
• Performs feasibility, site selection, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices, applicable laws and regulations SOPs and Work Instruction
• Performs Medical ethics Committee Health authority activity and can be involved in contract negotiation activities with investigator or hospital
• Evaluates the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalates quality issues to Clinical Team Lead, Project Manager and/or Linemanager
• Manages the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution
• Trains investigators and site staff (including laboratory, pharmacy and other staff involved) in the correct implementation of the protocol, the CRF and study-specific procedures and establish regular lines of communication with sites to manage ongoing project expectations and issues. And assists to organize CRA/ Investigator meetings, if applicable
• Develops and maintains an effective working relationship with site staff; Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action items by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation
• Ensures the correct reporting and follow-up of Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions
• Supports the investigator during inspections by healthcare authorities or audits
• Is involved in SOP development, maintenance and training.

JOB REQUIREMENTS

• Higher level of education preferably in an (bio)medical field
• Two or three years of relevant experience, as a CRA, in clinical research
• Up- to- date knowledge ICH-GCP guidelines, clinical trial regulations and legislation
• Effective oral and written communication skills in English and Dutch
• Proactive, strong communication and negotiations skills
• Ability to work independently as well as in a team matrix organization
• Ability to travel on an irrugular base
• Practical knowledge of Microsoft Office
• Driver’s License.

JOB COMPETENCIES

Ownership, initiative, stress resistant, planning and organisation, accuracy, customer focus, coaching, communication, partnership, persuasiveness.

 

COMPANY CULTURE

An open culture in an innovative and dynamic environment with a lot of inspiring colleagues.
Good working conditions.

 

Interested? Contact us via mail: office@schmidtconsultancy.nl or phone 0575-441001. We look forward to get in touch with you.