Clinical Study Manager

Job description

For the expansion of our client's clinical team, we are looking for a Clinical Study Manager.

The company is a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Their unique antibody engineering technologies combined with the complementary expertise of their people enables them to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs.


The Clinical Study Manager will have the following key responsibilities:

The CSM is responsible for all clinical operational aspects for the assigned global clinical studies from preparation until closure. The study responsibilities include:

  • Responsible for leading and guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical studies based upon metrics and plan
  • Leading CRO contracts negotiations together with the argenx vendor manager
  • Providing input into and/or developing study related materials such as Clinical Protocol, Clinical
  • Monitoring Plans, Data Management Plans, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, study drug order forms etc.
  • Overseeing and tracking patient recruitment and pro-actively identifies ways to prevent recruitment delays
  • Ensuring that study Trial Master File is maintained and up to date
  • Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable legislations
  • Reviewing monitoring reports, protocol deviations and data listings for studies to ensure reliable quality data are delivered and proactive identifies and solves issues/concerns
  • Facilitating timely availability of investigational product supply on site and ensuring that clinical site accountability records on site are maintained
  • Ensuring timely collection of documentation for adverse event safety monitoring and collaborating in submission of MedWatch reports to FDA, EMEA and other applicable regulatory authorities
  • Ensuring timely SAE reporting to the responsible IRB and Competent Authority agencies according to the applicable (local) legislation.
  • Establishing and maintaining good relation with clinical site and study personnel
  • Co-monitoring CROs personnel upon predefined plan
  • Pro-actively identifying and solving issues in the assigned clinical studies and timely escalating them to
  • Project Manager, Head of Clinical Operations or Senior Management, if needed
  • Leading and guiding the internal clinical study team and chairing study team meetings
  • Communicating in a transparent, clear way and motivating team members to work towards achieving clinical study goals
  • Preparing of study timelines and budget and delivering studies within timelines, scope and budget, aligned with the clinical development plan
  • Ensuring that the assigned studies are executed according to the argenx quality standards
  • Responsible for risk management of the assigned studies: performing (pre-)study risk assessment and ensuring that mitigation steps for potential risks are taken
  • Responsible and contact person during inspections/audits for the assigned studies together with the
  • Quality Assurance representative

The CSM will also participate in activities other than study-related which include but are not limited to:

  • Providing input to the clinical development strategy/plan
  • Co-writing/maintaining SOPs within the Clinical Operations department
  • Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study
  • Experience with tools and systems for managing clinical studies (MS project, study progress and metric systems, eCRF databases)
  • Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences,
  • Pharmacy, Veterinary etc.) or equivalent by experience
  • Minimum of 5 years of experience in Clinical Operations and managing CROs and vendors
  • Biotech experience is a plus
  • Auto-immune and/or oncology clinical study background is a plus
  • Belgian residence required
Our offer
  • A competitive salary package with extensive benefits
  • A work environment in a human-sized, dynamic, rapidly growing biotech company
Contact person

Lies Deboiserie

Personal profile
Contact details
Managing Partner

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