Crinetics Pharmaceuticals · 2 days ago
Clinical Trial Manager (Phase 3)
United States
Full-time
Onsite
Mid, Senior Level
$122K/yr - $152K/yr
7+ years expCrinetics Pharmaceuticals is a pharmaceutical company based in San Diego, California, developing therapies for rare endocrine diseases. The Clinical Trial Manager is responsible for executing phase 3 clinical studies, ensuring compliance with protocols, and managing cross-functional team interactions.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Provide oversight of late-phase clinical research studies across all functional areas of the drug development process
Provide operational and strategic input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc
Develop the subject recruitment/retention strategy and related initiatives
Oversight of TMF set-up, ongoing quality review, and final reconciliation of study documents, including review of site regulatory documents/packages and obtaining of appropriate site insurance
Development of training materials for study team, investigational sites, and vendors
Proactive management of information sharing with key stakeholders using standardized reports and other mechanisms
Assure clinical studies are compliant with ICH/GCP and other regulations as appropriate
Oversee preparation of RFPs and prepares bid templates to facilitate selection of the CROs/vendors
Collaborate with counsel to negotiate and draft research contracts and agreements with CROs/vendors and clinical study sites, as needed
Acts as liaison with Regulatory Affairs to assure adherence to GCPs; maintenance of SOPs; and assure site and CRO/vendor audits are completed
Perform study risk management and implement mitigations
Identify potential study issues and recommend and implement solutions or corrective actions as needed
Create realistic plans that clearly define goals, milestones, responsibilities and results
Maintain focus on strategic objectives while accomplishing operational goals
Make timely, data-driven decisions
Qualification
Required
Bachelor's degree required with 7 years of experience of prior clinical operations experience preferably with CRO/small biotech experience
2 years in a supervisory role
Must be able to travel up to 25% of time, may be higher in accordance with project requirements
Computer skills should include proficiency with Microsoft Office suite of software, electronic TMF systems, IXRS and EDC systems
Excellent understanding of drug development process
Able to make appropriate decisions to move the project(s) forward
Effective verbal and written communication skills
Data flow from sites to data processing, review, and resolution
Analysis and report generation
FDA regulatory requirements (i.e. GCPs, CFRs, etc.). Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential
Study initiation procedures
Ability to exercise judgment and determine appropriate action
Benefits
Discretionary annual target bonus
Stock options
ESPP
401k match
Top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
20 days of PTO
10 paid holidays
Winter company shutdown
Company
Crinetics Pharmaceuticals
Crinetics is a clinical-stage pharmaceutical company that develops therapies for people with rare endocrine diseases.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2BKey Investors
Frazier Healthcare PartnersNational Institutes of HealthPerceptive Advisors
2026-01-07Post Ipo Equity· $349.22M
2024-10-08Post Ipo Equity· $500M
2024-02-28Post Ipo Equity· $350M
Leadership Team
R. Scott Struthers
Founder, CEO
A
Alan S. Krasner
Chief Endocrinologist
Recent News
2026-01-07
2026-01-07
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