Senior Study Start Up Specialist
il y a 20 heures
Parexel is seeking a highly skilled Senior/Lead Study Start Up Specialist to join our single sponsor dedicated team in France. As a key member of the Local Study Team, you will be responsible for managing and conducting start-up activities in compliance with client procedures, documents, local and international guidelines such as ICH-GCP and relevant regulations.
Key Responsibilities:- 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.
- 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.
- 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).
- 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.
- 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.
- Bachelor's degree in related discipline, preferably in life science, or equivalent qualification.
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