Manager, Clinical Operations
10770 Wateridge Circle , Suite 210 San Diego, CA 92121 US
The Manager, Clinical Operations will oversee clinical trials sponsored by client and support the growth and development of the Clinical Operations department. This individual will oversee all aspects of clinical trial conduct including study start-up, enrollment, maintenance, and close-out
- Oversee all operational aspects of assigned clinical trial(s), including conduct such as study start-up, enrollment, study maintenance and close-out.
- Manage and track study timelines, budget, metrics, and milestones; reports status updates to senior management team.
- Develop and oversee completion of the clinical document below, including, but not limited to:
- Clinical study protocol
- Informed Consent form template: (master and/or country-level)
- Cell therapy product procedure manual and requisition forms
- Clinical monitoring/management plan including report templates
- SIV training slides
- Protocol training material
- ISF structure and template documents
- Other as needed study-specific documents, plans, charters, tools, trackers, etc. including that of CRO
- Principal contributor and reviewer of the clinical documents below:
- Clinical laboratory manual and requisition forms
- CRFs and CRF completion guidelines
- IRT manual
- Central imaging manual
- Edit check / data review plan
- Data review board charter (eg, DSMB, SRT)
- Safety management plan and SAE report form template
- Lead internal study team meeting and other internal clinical operations meetings and/or working group meetings. Participates as the study operations representative in other study-specific or internal meetings.
- Manage and/or participate in the selection process of vendors and/or contractors supporting a study, including but not limited to:
- Clinical trial monitors
- Central lab
- Central imaging
- EDC system
- IRT system
- Act as primary point of contact overseeing, managing, and tracking performance of vendors selected for a clinical study including budget review, invoicing, and the approval of study specific documents.
- Provide and/or ensures training for internal study team, vendors, third party contractors, and sites.
- Manage, oversee, and track performance of clinical sites selected for a clinical study.
- Offers sponsor review and approval of site-specific documents (eg, site-specific ICF, patient facing materials, etc.).
- Proactively identifies potential study issues/risks and recommends/implements solutions.
- Participate in the development, review and implementation of departmental SOPs and processes.
- Contribute to the selection of contractors or FTEs that join client.
- Other duties as assigned.
- Experience and/or knowledge of transplant patient care and apheresis collection for clinical trials strongly preferred.
- Experience managing and selecting CROs and other clinical trial vendors (eg, central lab, central imaging, etc.).
- Thorough knowledge and understanding of ICH guidelines, GxPs for conduct of clinical trials, and FDA and EMA regulations.
- Excellent interpersonal, verbal and written communication skills, while being able to work and think independently, to support a collaborative work environment.
- Strong analytical and problem-solving skill; and be able to proactively identify and communicate risks and/or other issues and develop appropriate mitigation, action plans, or solutions in collaboration with key stakeholders.
- Strong clinical research knowledge and cross-functional understanding of clinical trial methodology with proven ability to execute clinical trials within expected timelines and budget.
- Ability to deal with time demands, incomplete information or unexpected events
- Attention to detail required.
- Outstanding organizational skills with the ability to multi-task and prioritize
- Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
- Willing to travel at least 10 – 20%.
- Minimum requirement of a BA/BS or equivalent degree, plus 3 years of direct experience in clinical operations supporting clinical drug development within the oncology and/or cell therapy space; OR minimum 5 years of direct experience in clinical operations supporting clinical drug development with no experience in oncology and/or cell therapy clinical studies.
**CO candidates may not be considered
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