Title- Sr. Clinical Trials Management Associate (Junior CTM)
Location- Hybrid- South San Francisco
Type- FTE
Therapeutic Area- Oncology
The Sr. Clinical Trials Management Associate will support all aspects of clinical trial conduct including study start-up, enrollment, study conduct and close-out. The candidate must know clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. This role will require an ability to operate in a fast-paced, highly dynamic environment within a matrix team and have partnerships that include both internal and external stakeholders.
This is your chance to thrive in a fast-paced, high-energy environment, collaborating with both internal teams and external partners to bring transformative treatments to patients. If you’re ready to lead the charge and make a real difference, this is your opportunity!
WHAT YOU’LL DO
- Assist in all operational aspects of assigned clinical trials, including supporting the full trial process from vendor selection and study start-up through enrollment, ongoing study conduct, and close-out
- Assist in reviewing study-related and essential clinical study start-up documents (e.g., Clinical protocols, Informed consent forms, CTA/Budget, Investigational Product Manual, Monitoring Plan, Laboratory Manual, Case Report Form (CRFs), CRF Completion Guidelines, training documentation/tools, and other relevant study plans and charters)
- Responsible for apheresis planning to support enrollment of study participants and liaise with investigative sites and supply chain to support activities involved in the cell journey
- Coordinate with supply chain on all aspects of study participant sample collection and “cell journey” including apheresis, shipping, processing, manufacturing, and return of investigational product back to the clinical trial sites
- Collaborate with translational operations on bio-specimen sample routing, tracking, and query resolutions between clinical sites and the central lab and CROs.
- Assist with the review of IRB/EC documents in coordination with CRO, as appropriate
- Assist in site selection and the start-up processes toward activating sites
- Responsible for filing necessary documents in the electronic trial master file (eTMF), and for leading regular cross-functional reviews of the eTMF
- Maintain tracking of various study activities to assist the study lead with required updates required for senior leadership
- Assist in data review and/or data metric review in preparation for data cuts
- Assist in training and managing CRO and vendors such as Central lab, Imaging, etc
- Assist in CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring report review, site management, TMF, EDC, etc)
- Develop productive relationships with investigators and site staff as well as serve as a liaison and resource for investigational sites
- Participate in the development, review, and implementation of departmental SOPs and processes with supervision
- Support other studies as required
- Other duties as assigned
WHO YOU ARE
- BS/BA in nursing, science or health-related field with 4+ years experience of related oncology clinical trial management experience
- Competent knowledge of transplant patient care and apheresis collection is a plus.
- Clinical research knowledge and cross-functional understanding of the clinical trial methodology
- Willing to travel to clinical sites as needed
- Ability to productively and successfully deal with time demands, incomplete information, or unexpected events
- Must display strong analytical and problem-solving skills
- Outstanding attention to detail and organizational skills with the ability to multi-task and prioritize
- Demonstrated excellence in interpersonal, verbal, and written communication skills, with the ability to collaborate effectively within a matrix team environment
- Creative and innovative mindset to approach novel problem statements
- Willingness to learn and adapt to new technologies
- Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
