Clinical Project Manager
Our client is a global pharma company located at the west side of Brussels.
This function can be partially homebased.
- 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