Clinical Trial Manager (CTM)

About the role

This is a unique opportunity for a Clinical Trial Manager (CTM). You will be responsible for independently managing one or more Phase 1–3 studies or complex components of larger trials with cross-functional oversight and vendor management.

Responsibilities

• Apply advanced expertise and exercise considerable latitude to determine objectives and to develop effective solutions to guide the successful completion of complex assignments under limited supervision.
• Participate in the Clinical Study Execution Team (CSET) discussion and may lead aspects of the meeting agenda as it pertains to vendors, study metrics, etc.
• Drive site activation and document readiness activities; analyze enrollment and operational metrics, supporting the study lead in decision-making.
• Participate and sometimes lead meetings internally and externally with CROs, vendors, and multi-functional teams with minimal supervision.
• Lead TMF reconciliation and inspection readiness activities.
• Support the review of study documents such as protocols, ICFs, CRFs, monitoring plans, etc.
• Lead department process improvement initiatives.
• Participate in CROs/vendor trainings as it relates to a limited aspect of study requirements.
• Manage the CRO and some ancillary vendors and ensure deliverables.
• May participate in the interview process for similar or junior roles within Clinical Operations.
• Mentor and support Clinical Trial Assistants (CTAs) and Clinical Trial Management Associates (CTMAs).
• Follow up and follow through on team action items and identification, escalation, and resolution of issues as needed.
• Review and identify trends when performing routine data surveillance of data listings, and support in the preparation of interim and final Clinical Study Reports and the resolution of data discrepancies.
• Support other Clinical Operations activities as appropriate.

Requirements and Qualifications

• BS, BA, or RN in a relevant scientific discipline.
• 5–7+ years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
• Advanced knowledge of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures.
• Strong communication and coordination skills; global trial experience and strong operational judgment.
• Proactive contributor to trial execution and issue resolution, with strong ownership of responsibilities for complex studies with multiple sites.
• High sense of priority and commitment to excellence in the successful execution of deliverables.
• Ability to analyze operational data, perform with an emphasis on quality, timeliness, and multitasking, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
• Travel may be required (~15%).

Preferred Qualifications

• Decision-making skills.
• Familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
• Oncology experience, early and/or late stage, strongly preferred.

Pay

Pay Rate: $80 – $85 per hour

Schedule

Location: Redwood City, CA – Remote Role