The Manager/Sr. Manager, Clinical Operations will collaborate across a variety of functional groups including Clinical Development, Biostatistics and Data Management, Regulatory, Clinical Supply Chain, Project Management, Contracts and Finance in support of the execution of clinical trials.
Essential Duties and Responsibilities
- Manage the execution of phase 1-3 clinical trials in an out-sourced model from study start-up to final clinical study report; anticipate problems and propose risk mitigation plans to ensure successful and timely completion of the trials.
- Oversee CRO study conduct to monitor adherence to regulatory requirements, GCP per relevant contracts.
- Oversee CRO generation of applicable clinical documents, study-related manuals and procedures.
- Communicates study status reports to Project Team and Sr. leadership on a routine basis.
- Provide oversight of Trial Master Files for assigned clinical programs.
- Provide oversight and input to additional study-related external vendors, including execution of work and tracking of milestones and deliverables.
- Participate in Request for Proposals (RFP) and in the selection of CROs and other applicable vendors.
- Collaborate across a variety of functional groups including Clinical Development, Biostatistics and Data Management, Regulatory, Drug Supply, Project Management, Contracts and Finance to plan and execute responsibilities.
- Perform study site visits to provide Sponsor-level support as required.
- Provide clinical input to protocol and other documents as required.
- This position has some project management responsibility and no direct reports currently, but will collaborate internally and with CROs to plan, execute and close out clinical trials.
In addition to the responsibilities above:
- May assist with Standard Operating Procedure (SOP) development and implementation.
- Leads study team in RFP process and selection of CROs and applicable vendors.
- Independently leads Study Execution Team meetings and escalates issues to functional leadership and/or Clinical Development Team as appropriate.
- Proactively identifies trial risks/mitigations and escalates to Clinical Program Lead in a timely manner.
- May represent Clinical Operations at Development and/or Project Team meetings
- BA/BS in a relevant scientific discipline required.
- 8+ years experience in trial management for industry sponsored trials.
- Prior experience as a clinical research monitor required.
- Experience in oncology and/or auto-immune mediated diseases required.
- Experience leading global clinical trials and oversight of full-service CRO and/or third-party vendors is required.
- Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
- Working knowledge and experience with Word, PowerPoint, SharePoint and Excel.
- Excellent interpersonal skills and demonstrated ability to lead is required.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Creative problem solver with the ability to address issues quickly and independently, balanced with judgement to escalate issues as needed.
- Strong attention to detail and dedication to accurate and high-quality work.
- Focus on results, highly collaborative cross functionally, and proactive.