Director, Clinical Operations - Great Boston Area (some remote flexibility)
Summary of job description:
The Director of Clinical Operations will provide leadership, project management, and program oversight to plan and conduct one or more high quality clinical trials concurrently in accordance with CFR, EMA, and ICH GCP regulations in support of regulatory authority submissions. The Director of Clinical Operations will manage all operational aspects of clinical development projects.
- Will take initiative to continually monitor each external vendor in performance management, escalate issues where appropriate, and make the appropriate changes in order to ensure trial conduct is completed in compliance and meets company's business objectives.
- Responsible and accountable for the conduct of clinical trials.
- Oversee, lead, and manage cross-functional team resources and external service providers (including clinical operations, medical monitoring, safety, data management, auditors, and consultants) to conduct trials on time, on budget, in compliance, and of highest quality.
- Coordination/execution of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review and approval of request for investigational test articles).
- Work collaboratively with cross functional internal and external teams including regulatory affairs, medical writing and biostatistics
- Identify, qualify, audit, and manage all external vendors, including CRO's.
- Ensure clinical trial team and clinical trial sites are properly trained and in compliance protocols, drive site selection, and patient recruitment programs that deliver enrollment targets. Performs site monitoring with field team, as needed.
- Facilitates all start-up activities including but not limited to investigational site contracts, investigational sites, and ethics committee submissions.
- Facilitate confidentiality agreements, negotiate study agreements and budgets with sites and external vendors.
- Responsible for writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB submissions/approvals, site activations, monitoring plan and tools, CRFs, DMP, edit checks, safety plan, DMC charter, close-out plans, and CSR's.
Experience and skill requirement:
- Minimum of 13 years of clinical research and/or clinical project management experience in domestic and international clinical trials.
- Excellent working knowledge of ICH, GCP guidelines, CFR, EMA, and HIPAA regulations.
- Able to work independently and make appropriate strategic decisions to operationalize and move the clinical trials forward.
- The ability to manage multiple priorities, while maintaining attention to detail is critical.
- Experience operating effectively within a matrixed environment, specifically in a healthcare/pharmaceutical start-up setting.
- Possess strong and influential leadership skills with proven ability to lead internal and external team members at all levels.
If you or a Director you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role.
Sthree US is acting as an Employment Agency in relation to this vacancy.