The CTM/Sr. CTM is responsible for the management of clinical trials from study start-up activities through the clinical study report. This role drives completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identifies, communicates and resolves clinical study operational issues; and participates in process improvement initiatives as required.
- Manages all clinical aspects of study under oversight of Clinical Operations senior management including: initial operational feasibility, study timelines, budget and metrics; study document development and review (training documentation, ICF, study specific plans, eCRF Guidelines, lab and radiology manuals, etc.), plans and manages study-specific meetings (e.g. Study Team Meetings, Investigator meetings, etc.).
- Ensures clinical trials are executed in compliance with the protocol and ICH/GCP guidelines/regulations: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation; reviews monitoring reports to ensure quality and resolution of site-related issues. Includes interfacing with QA for CAPA documentation and resolution.
- Manages the study submission to IRB/ECs in coordination with CRO, as appropriate.
- Leads selection activities for external vendors and is responsible for the management/oversight of external vendors including: the development vendor specifications; review vendor reports, budgets, and metrics.
- Works with Clinical Operations senior management and finance to manage the study budget. And ensures it aligns with department financial goals; reviews and approves clinical invoices against approved budget and work performed. Coordinates review of updates or revisions with key cross-functional partners, as necessary.
- Manages the internal review of investigator contracts and payments, as necessary.
- Prepares and presents project debriefings to Clinical Operations management.
- Uses operational and therapeutic expertise to optimize trial execution and works with the study team to implement operational strategy.
- Works with the CRO to select and approve sites and manages start-up processes toward activating sites; develops relationships with investigators and site staff.
- Interfaces with cross-functional teams as Clinical Operations study lead (e.g. Medical Monitor, Regulatory Affairs, CMC/Supply Chain, CRO, vendors and Investigators/site staff). Works cross-functionally and with external vendors to proactively manage the execution of the clinical trial.
- Provides study-related guidance and leadership to internal and external partners, as appropriate.
Education & Professional Experience
- Bachelor’s degree or equivalent combination of education/experience in science or health-related field.
- Minimum of 4-7 years of clinical trial management experience in a Pharmaceutical/Biotech organization.
- Phase 1-3 trial experience, including global trials, strongly preferred.
- Oncology experience, with T-cell immunotherapy experience preferred.
- Robust understanding of ICH/GCP, and knowledge of regulatory requirements.
- Strong clinical study/project management skills.
- Excellent communication and organizational skills (ability to prioritize a number of tasks of varying complexity), along with problem solving, conflict resolution, leadership and team-building skills.
- Ability to succeed in a remote work environment, including the ability to maintain necessary team communication
- Candidates may be based in Los Angeles, CA, San Francisco, CA, Cambridge, MA and their surrounding areas.
Travel: Travel is required (up to 25%)
Physical Requirements: Subject to periods of sitting or standing, vision is required to monitor data. Work is generally performed in an office environment.