Clinical Trial Manager (ONC)
New
T
Tyra BiosciencesClinical trials
Location: Remote, US; Workplace: RemoteFull-TimeManager
SalaryBase Salary Range: $148,304 - $162,985 USD
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Job Details
- Experience
- Minimum 6-8 years relevant work experience; 1-2 years in a CTM role preferred.
- Required Skills
- Project ManagementMS Office
Requirements
- Bachelor’s degree in life sciences.
- Minimum 6-8 years of relevant hands-on clinical trial support experience in a pharmaceutical or biotech environment; a combination of CRO and pharma/biotech experience is considered.
- Extensive experience overseeing and managing early-phase and global registrational clinical trials.
- Experience managing external vendors and CROs, including leading vendor team changes.
- 1-2 years in a CTM role preferred.
- Strong project management skills.
- Extensive knowledge of ICH/GCP, FDA regulations, clinical trial processes, and protocols.
- High competency with eTMF, CTMS, EDC, or related electronic systems.
- Proficiency in MS Office applications and comfort with technology.
- Ability to work independently with minimal direction and within a team structure.
- Minimal travel required (5 to 10%).
Responsibilities
- Support clinical trial execution from protocol concept through the clinical study report.
- Assist with study set-up, including protocol and consent preparation, systems, regulatory submissions, manuals, training materials, investigator documents, and study plans.
- Prepare and maintain study files, organize meetings, record minutes, and ensure documentation is archived.
- Coordinate clinical trial equipment, supplies, and cross-functional project activities.
- Ensure study-specific training compliance and review the TMF for completeness.
- Support inspection readiness and help sites prepare for clinical audits and inspections.
- Assist with budget management and day-to-day study operations in accordance with SOPs, ICH/GCP guidelines, and regulatory requirements.
- Track subject and site metrics, perform quality checks, and identify and escalate issues affecting deliverables.
- Collaborate with CROs on TMF collection and archiving, and coordinate essential-document submissions with regulatory affairs.
- Support study close-out, including TMF and drug reconciliation, and work toward study timeline, enrollment, site activation, and data-cleaning goals.
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