Top tier Pharmaceutical company
Clinical Operations is critical to the success of Company’s R & D strategies; our team is expanding and seeks a Study Team Leader to continue our growth in novel cellular immunotherapies. You will be responsible for study team management for phase 1 – 3 gene therapy trials in hematology oncology arena, the planning and execution of complex clinical trial in accordance with corporate timelines, and assist in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials.
The primary skills of the Study Team Leader include logical thinking, ability to prioritize, a flexible “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. The ideal candidate will have previous experience running pivotal trials and FDA inspection experience.
- Provide clinical trial management expertise, leadership and guidance to in-house and out-sourced study team members, ensuring process consistency and knowledge sharing.
- Manage multidisciplinary study team(s).
- Identify clinical trial investigators, perform pre-study visits for complex trials, manage site initiation visits, and develop trial-related training materials for study team members and clinical staff.
- Analyze and report safety issues, patient care issues and study design and/or study conduct issues.
- Prepare detailed study timelines and contribute to development of clinical site budgets for assigned clinical studies.
- Develop action plans to address issues with investigators, clinical sites, or Clinical Research Associates (CRAs) and direct study monitoring priorities.
- Maintain regular contact with relevant internal departments such as Manufacturing, Operations, Regulatory, Project Management, Quality Assurance, and Research.
- Develop and direct operational documents such as clinical monitoring plan, study management plan, study consent form, communication plan, medical oversight plan, study safety oversight plan, laboratory manual, and product administration guidelines.
- Work with Medical Writing and assigned Medical Director to develop clinical study protocols.
- Assist in the preparation of investigator brochures, clinical study reports, clinical sections of INDs, Appendix M, IND annual reports, etc.
- Collaborate with Quality Affairs staff to develop a quality plan, including audit readiness assessments, for assigned clinical trials.
- Ensure the study eTMF is maintained, complies with company standards, and is periodically audited throughout the clinical trial.
- Contribute to departmental Standard Operating Procedures (SOPs), procedures, and template forms.
- Identify and manage vendors as necessary to meet study goals and timelines. May develop RFPs and initiate contracts for CROs, central, bioanalytical or specialty laboratories, core radiology reading groups, etc.
- Produce monthly progress reports and risk mitigation plans to ensure assigned clinical trials are on target.
- May perform co-monitoring, as necessary.
- Eight or more years’ experience in clinical trial operations with at least 3 years’ experience in the management of complex oncology clinical trials. Previous hematology trial experience and experience with FDA inspections is desirable
- Thorough knowledge of FDA regulatory requirements, ICH guidelines and GCP
- Demonstrated proficiency in the implementation, monitoring and management of clinical trials
- Clear and concise verbal and written communication skills
- Strong organizational and motivational skills, with an exceptional attention to detail
- Proven experience successfully juggling multiple teams, external sites and projects in a dynamic environment
- Experience working with partner organizations both academic and pharma, biopharma, or CRO
- Proficiency with MS office suite, including MS Project, and SharePoint
- Availability to work onsite in Seattle office
- Ability to travel approximately 30-40%, including some weekend travel for business and to attend meetings
- Bachelors’ degree in scientific discipline required, MS or equivalent preferred
- Oncology or ICU nursing background desirable
* Can be based in San Francisco, CA or Seattle, WA