Parexel has an exciting opportunity for a Study Start-Up Manager to join our single sponsor dedicated team in France.
Job Summary: The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the Client procedures, documents, local and international guidelines such as ICH - GCP and relevant regulations.
Working in close collaboration with CRAs and the wider local study team, the SSU Manager will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics, ensuring that study start-up activities and milestones are achieved in a timely and efficient manner.
Key Accountabilities: Trial and site administration Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
Actively participate in Local Study Team (LST) meetings.
Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.
Provide feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
Support Study Management and Monitoring (SMM) in different initiatives (local, regional or global) as agreed with the SMM Line Management.
May support site selection process by identifying and assessing potential sites/investigators.
Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements.
Support Quality Control (QC) checks performed by study lead or delegate to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol and in line with client SOPs.
Regulatory and site Start Up responsibilities Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process.
Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period.
Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
May be accountable for continuing submission of proper application/documents to IEC/IRB and to Regulatory Authorities for the duration of the study.
Budgeting, Agreements and Payments May be accountable for preparation, review and negotiation of contracts with investigational sites being the primary point of contact for investigational sites to ensure the contracts are fully executed.
Assist where required in initial forecasting for budget, study materials and drug supplies.
Plan applicable local drug activities (local purchase or reimbursement).
Skills and Experience: 2 years' experience in a similar position in either CRO or Pharma.
Good collaboration, interpersonal, verbal and written communication skills.
Excellent attention to detail and negotiation skills.
Proficient in written and spoken English language required.
Fluency in French is essential.
Analytical and problem-solving skills.
Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
Demonstrative ability to prioritize and manage multiple tasks with conflicting deadlines.
Knowledge and Experience (Essential) : Good knowledge of international guidelines ICH-GCP as well as relevant local regulations, basic knowledge of GMP/GDP.
Excellent understanding of Clinical Study Management and study start-up.
Basic understanding of drug development process.
Education: Bachelor's degree in related discipline, preferably in life science, or equivalent qualification.
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