Clinical Research Specialist

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for an experienced Clinical Research Specialist to work with one of our partner biopharmaceutical companies. This is a full-time (1 FTE) position, to work hybrid at their office in Diegem, initially for a 12 month fixed term contract, with the possibility of extension.  

The Clinical Research Specialist will join the Post-Marketing Clinical Follow-Up team, which is linked to clinical studies but despite it’s name, nothing to do with post-marketing studies. The selected candidate will provide data for the documentation for the team, write and review technical and medical documentation, comply with Medical Device Regulation (MDR), regulatory and clinical domain. The ideal candidate is someone who has previous experience with Post-Marketing Clinical Follow-Up (PMCF) and Medical Device Regulations (MDR).

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

 

Main Job Tasks and Responsibilities:

• Draft and maintain the Post-Marketing Clinical Follow-up (PMCF) Plans and the Post-Marketing Clinical Follow-up (PMCF) Evaluation Reports.
• Support in optimizing the Post-Marketing Clinical Follow-up (PMCF) process (SOP/templates), as part of the Post-Marketing Suvellience (PMS) and to keep the clinical evaluation up to date.
• Review and contribute to the Periodic Safety Update Reports (PSURs). Ensure alignment with Post-Marketing Clinical Follow-up (PMCF) findings.
• Review and contribute to Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance (SSCPs) and State of the Art (SoA) Protocol and Report. Ensure alignment with Post-Marketing Clinical Follow-up (PMCF) findings.
• Assist in data analysis and interpretation to assess product safety and performance.
• Contribute to Post-Marketing Clinical Follow-up (PMCF) Evaluation Reports, summarizing findings and clinical relevance.
• Maintain documentation for audits, inspections and regulatory submissions. Prepare, assist and attend where relevant.
• Collaborate to address feedback from Notified Bodies and Competent Authorities.
• Work closely with Clinical Research and Scientific Operations, Regulatory Affairs, Medical Affairs, Post-Marketing Surveillance and other departments as appropriate.
• Support training and awareness initiatives related to Post-Marketing Clinical Follow-up (PMCF) to optimize collaboration.

 

Education, Experience and Skills:

• BSc in a life sciences discipline, or similar.
• Experience with Medical Devices, including familiarity with Medical Device Regulations (EU) 2017/745 and MDCG 2020-6/7/8.
• Experience with Post-Marketing Clinical Follow-up (PMCF).
• Experience with medical writing.
• Strong writing and analytical skills.
• Attention to detail.
• Ability to connect the dots across different sources and cross-functional inputs.

 

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

 

Who will you be working for?

 

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

 

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

 

 

Key words: Post-Marketing Clinical Follow-up, PMCF, Medical Device Regulation, MDR, MDCF, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated