|Title:||Clinical Study Manager II|
|Location:||Seattle, WA 98021|
This individual will play a key role in assisting the Clinical Development team in conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials.
The Sr. CTM provides operational leadership to the clinical operations team to ensure project milestones delivery on time, within budget, high quality, and in compliance with the ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/Work Instructions (WIs).
The CTM should have critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study (ies) with effective communication across organization. This position may have line management responsibilities.
- Oversight and day to day management of CRO and/or in -house Clin Ops Team
- Oversight of Clinical Operations Study Team
- Management of Direct Reports as necessary
- Able to manage CRO budget and adjust up or down as necessary
- Select and manage a variety of vendor types
- Lead defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines
- Serve as a member of one or more Clinical Operations study teams
- Participate in CRO and vendor selection; develops RFPs for study vendors, review proposals and make CRO and vendor selection recommendations in collaboration with the Study Team
- Day-to-day management of CRO and assigned vendors to ensure that project goals are achieved; organize and lead teleconferences with key vendor personnel, facilitate vendor activities and oversee adherence to scope of work and service agreement
- Participate in developing & finalizing cross-functional Study Team deliverables such as clinical study protocols, CRFs, consent forms, study reference manuals, study reports, annual reports and other clinical documents
- Review invoices for assigned vendors, provide input to study budget forecast
- Conduct site feasibility and partner with Study Team and CRO if applicable to identify and select clinical trial sites
- Partner with Contracts department on the development of site budget and clinical trial agreement (CTA) templates and on the negotiations with clinical sites. Ensure site payments are accurate and reconciled against patient visits.
- Perform oversight and/or co-monitoring visits of clinical sites, as required
- Review CRO monitoring reports or field staff monitoring reports and ensure completion of action items. Identify trends and risks. Escalate unresolved issues.
- Partner with Study Team, vendors, and sites to ensure that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled
- Participate in data review as required
- Help create and implement assigned study management plans, (e.g. monitoring, vendor oversight, TMF oversight)
- Proactively identify issues and risks and propose mitigation strategies
- Assist with planning investigator meetings and developing content and/or site training materials
- Assist with training vendors and team members on study protocol and processes
- For studies managed in-house lead and coordinate activities of Clinical Operations staff
- Help coordinate data review and KPI monitoring
- Occasional travel