[JOB PURPOSE/PRIORITIES] The Clinical Project Leader (CPL) is responsible for the set up and progress of a clinical study within the country, ensuring compliance with sanofi-aventis quality standards and regulations in force, the forecasted timelines, milestones and budget. The CPL represents the country at the CSU CTT and is the main contact for the Regional Trial Manager (RTM)/Clinical Trial Operations Manager (CTOM) for R&D studies and Strategic Clinical Research team (SCR) for local studies.
[KEY ACCOUNTABILITIES] 1. Is accountable for set-up activities according to the company standards, regulations in force and country generic administrative timelines (submission to ECs/IRBs/HAs, approvals, contracts with sites, local AEDs), and that committed targets and timelines are met at all steps and until study completion (recruitment, active/inactive sites, deadlines for DMCs, DBL, closure of sites, archiving).
2. Participates in/organizes the kick-off meeting. - Organizes training of monitoring teams (study procedures, study devices, monitoring plan,¡¦). - Organizes local investigators meetings with CRAs and CPAs. - Provides support to MTs (protocol training, co-monitoring visits¡¦)
3. Prepares local study AED with optimal costs - Ensures the implementation of IT systems in the country (IXRS, ePortal, eCRF, CTP etc.) - Ensures adequate provisioning/import of devices and materials in the country enough in advance - Participates in the revision/preparation of study progress tools (newsletters,¡¦)
4. Gives inputs on the feasibility studies and performs study site selection visits with CRA.
5. Maintains and ensures the completeness of the local study files. Ensures the completeness of local study files in readiness for archiving.
[QUALIFICATIONS] Language skills: Ability to present clear messages accurately in both written and spoken English from complex information/data to all levels in the organization.
Education: University degree in Health Sciences or equivalent
Experience & knowledge: Minimum of 5 years of experience in clinical research
Core competencies: Knowledge of GCP/ICH phase I-IV clinical trials, pharmacoepidemiology studies, vaccine studies. leadership and communication skills, organizational, analytical and planning abilities, reactivity to emergent needs, able to prioritize, time management.