CURRENT OPPORTUNITIES
GLOBAL STUDY MANAGER
Key Responsibilities:
Lead a cross functional global study management team. Develop study timelines, budget, risk and quality plans. Management of CROs and vendors to ensure deliverables against scope of work are met.
Your Background:
Life Sciences degree or substantial Clinical Research experience. Good knowledge of ICH GCP is essential.
Proven Trial Management (at least 3 years) experience within a global setting is essential. Vendor and CRO management experience. Operational leadership experience.
CLINICAL RESEARCH ASSOCIATE
Key Responsibilities:
Site identification, feasibility and selection. Performing qualification, initiation, routine monitoring and close-out visits in accordance with the relevant SOPs and according to GCP. Identifying and resolving issues and potential site and study issues. Training of site staff as required. Preparation of regulatory and ethics applications.
Your background:
A relevant life science degree. Proven experience of monitoring clinical trials Previous experience of study site management. Thorough understanding of ICH-GCP and relevant regulatory requirements. Experience of using software systems such as CTMS, EDC, IXRS and eTMF