Senior Clinical Research Specialist
Há 4 dias
About the Role:
As a Senior Clinical Research Specialist at Phiture, you will play a pivotal role in ensuring the smooth conduct of clinical trials in Portugal. You will be responsible for capturing and aligning needs across R&D, Medical Affairs, and local Business Units.
Key Responsibilities:
- Act as the primary point of contact for clinical trial-related activities with Iberic CSU Leadership Team, CSU Medical Advisors, Clinical Project Leaders (CPL), Site Partnership Manager (SPM), CTA Regulatory Manager (CTARM), and other CSU team members.
- Represent Sanofi R&D in front of external stakeholders in Portugal and ensure traceability of R&D investments.
- Support regulatory activities, including updating CTARM on new regulatory requirements and participating in regulatory meetings.
- Interact with Health Authorities and Central Ethic Committee and bridge between Iberic CTARM and local teams.
- Main contact for APIFARMA and participate in Pharmaceutical Association meetings related to clinical studies.
- Distribute APIFARM Newsletter to relevant stakeholders.
- Align with CT priorities and targets and attend operational feasibility meetings.
- Sites identification and management, contributing to site lists agreed with SPM and Medical Advisors.
- Liaise with Cluster CPL to support sites in resolving issues and achieve Sanofi standards.
- Negotiate financial agreements with Contract Specialists and Legal Department for Clinical Studies.
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