- 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
- Ensure that study is Inspection ready through the study lifecycle and partake in CAPAs when needed
- Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
- Collaborates with Clinical Science, 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
- Oversees TMF
- Manages study budget and timelines
- Management of vendors, including a CRO, to the required standards
- Bachelor's degree
- Experience & knowledge of clinical project management
- 8+ years of relevant and progressive clinical trial management experience
- Experience & knowledge of clinical project management
- Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
- Experience in running a trial from start to finish; initiating the trial that includes protocol development, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out.
- Strong understanding of clinical trials processes, protocols, and medical terminology
- Protocol development experience
- 25% travel required
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Clinical Operations Manager - California, United States - BioPhase
Description
Candidates must be located in the United States
Reporting to the Associate Director of Clinical Operations, the Clinical Trials Manager will be accountable for managing the clinical operation activities for 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.
Responsibilities:
Qualifications:
