Proclinical is currently recruiting for an Associate Director of Clinical Operations with a clinical-stage pharmaceutical company located in New York, NY. Successful candidate will be accountable for the implementation, management and reporting of assigned clinical trials.
Ensure successful completion of clinical studies that are on time and within budget. Works with the Director, Clinical Operations to ensure all needed aspects of clinical operations are identified (vendors, resources, contracts, budgets, etc.) and planned in timely manner.
Generates contingency plans where necessary, proactively identify potential issues/risks and mitigate, keeping manager informed.
Oversee the coordination of Investigator Meetings and necessary training of internal team and CRO study team staff.
Manage and monitor performance of all CROs and vendors to ensure successful completion of program in alignment with timelines and budget.
Escalate potential variances from the timeline/budget real time and proactively to the Director, Clinical Operations to manage changes to scope.
Has input into estimated study budget and supports RFI/RFP process for studies/programs.
Partners with Finance to manage forecasts and actual spends against the study budget on an ongoing basis.
Manage and report on performance metrics for the larger team/senior Clinical Operations team to ensure that trials/development program plans are on target.
Provide direct line management and support to more junior members of the operations team: Clinical Trial Manager, Clinical Trial Associate/In-house CRA.
Collaborate with other matrixed resources across the study team on activities and issues: Data Management, Programming, Biometrics, Safety/PVG, Clinical Research Liaisons, Clinical, Project Management, Clinical Supplies/CMC.
Skills and Requirements:
Bachelor's degree in Life Sciences, Pharmacy or Life Sciences. Advanced degree preferred.
Experience (e.g. Jobs, supervisory, industry, international, etc…):
5+ years of direct experience managing studies at a sponsor or with a CRO is required. The Director must be able to work collaboratively with others both internally and externally. 1+ years of oversight of team and/or direct oversight of Operations team members.
Good working knowledge of GCP and ICH guidelines
Demonstrated alignment with Axovant values and culture
This position requires approximately 20% travel
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Tong at (+1) 646-878-6308 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.