Reporting to the Associate Director / Director of Clinical Operations, the Sn Clinical Operations Manager will be accountable for managing the clinical operation activities for 2 to 3 clinical studies. This person will be key in driving the clinical studies day to day activities, ensuring on time delivery of main clinical milestones, as well as respect of GCP.
Key Elements and Responsibilities
- Lead, manage and co-ordinate the conduct of assigned clinical trials from study start-up to close out in accordance with ICH-GCP
- Oversees the quality of the clinical operations for the studies he/she is in charge of
- Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
- Coordinates medical writing and all the activities necessary for delivering of documentation: publishing, QC, etc
- Manages data management and statisticians ensuring data base maintenance, interim and final database locks.
- Manages clinical sites and academics institutions, ensures adherence for keeping clinical records, source documents, data entry, manages clinical trial logistics, applications (IRB, local agencies)
- Planning, management and reporting of clinical studies through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables
- Ensuring implementation and conduct of study(ies) in accordance with ICH-GCP guidelines
- Ensures development, review, finalization and delivery of high quality key study documents in order to meet study timelines.
- Manages CRFs creation, implementation, collaborating closely with data management for the study activities
- Ensures accurate maintenance and archiving of study records
- Management of study budget and timelines
- Management of vendors, including a CRO, to the required standards
- Expererience & knowledge of clinical project management
- Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
- Understanding of regulatory environment, GCP/ICH
- Experience working in an academic environment is a plus, as well as experience in orphan disease field
Skills and Abilities
- Excellent organisational and communication skills;'
- Can-do' attitude and willingness to be flexible
- BsC in life sciences
- Msc/PhD in life sciences is a plus