Clinical Project Manager

Reference: HAR-16-002


Our client is a global pharma company located at the west side of Brussels.

This function can be partially homebased.

Main purpose

  • To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with¬†Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.


  • Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA.
  • Lead Local Study Team(s) consisting of monitors and study administrator(s).
  • Contribute to review of monitoring visit reports and pro-actively advice the Monitor(s) on study related matters.Proactively identify and facilitate resolution of complex study problems and issues.
  • Perform QC and co-monitoring visits
  • Report study progress/update to the SMO Study Leader/Team.
  • Contribute to patient recruitment strategy with monitors, including regular communication with concerned Investigators as necessary.
  • Communicate and co-ordinate regularly with National Co-ordinating Investigator/National Lead Investigator on recruitment and other study matters.
  • Coordinate the process for selection of potential Investigators considering capability, competence, etc, of the Hospitals/sites.
  • Plan and lead national Investigator meetings, in line with local codes
  • Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs.
  • Work in close coordination with Study Drug Coordinator to create a robust Drug Consumption Plan.
  • Prepare and maintain study budget at country level in ACCORD.
  • Ensure timely preparation of country SMA, country fSMA and country Master CSA.
  • In collaboration with the local study team, ensure completeness of the electronic Trial Master File and/or paper Trial Master File on country and site level, and ensure essential documents are sent to SMO/Hub location/site.
  • Facilitate translation of documents (ICFs, patient diaries, participation cards, etc) through external providers.
  • Ensure timely submission of proper application/documents to EC/IRB.
  • Work together with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority.
  • Set up and maintain the study in IMPACT and/or other Clinical Trial Management System, at study country level
  • Ensure accurate payments related to the study are performed.
  • Participate in training and coaching new members of the Local Study Team.
  • Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
  • Plan and lead activities associated with audits and regulatory inspections in liaison with Line Manager, Clinical Process Manager and CA&A.
  • Provide input to process development and improvement.
  • Provide regular information to SMM Director/CRM at country level on study/ies and planned study milestones/key issues.
  • Update SMM Director/CRM about the performance of the monitors/CRAs.
  • Ensure that study activities at country level comply with company Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment)


  • Preferably master degree
  • At least 2 years experience as CPM at country level

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