Senior Clinical Trial Manager
Categories: Clinical Operations
Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with rare endocrine diseases. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.
Position Summary:
The Senior Clinical Trial Manager is responsible for managing the execution of clinical studies and data collection. The incumbent oversees the review, monitoring, and adherence to clinical protocols, taking ownership of key projects and working independently. The Senior Clinical Trial Manager will interact internally and externally with members of the cross-functional study team and may supervise more junior CTMs and Associate CTMs as required.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
- Provide oversight of clinical research studies across all functional areas of the drug development process.
- Provide operational and strategic input into study planning and study specific 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.
- Coordinate and lead study team meetings and provide[PC1] key stakeholders with updates on study progress including timelines, budget, and key milestones for the study.
- Develop the subject recruitment/retention strategy and related initiatives.
- Oversee 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, and/or supervision of team members performing these activities.
- Develop training materials for the study team, investigational sites, and vendors.
- Manage information proactively by 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 prepare bid templates to facilitate selection of the CROs/vendors, and/or collaboration/supervision with team members performing these activities.
- 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.
Education and Experience:
Required:
- Bachelor’s degree required, preferably in a scientific discipline. An equivalent combination of relevant education and applicable job experience may be considered.
- Minimum of 8 years of prior clinical operations experience managing clinical trials, preferably with CRO/small biotech experience; at least 5 years in a supervisory role. Experience managing early phase studies is preferred.
- Must be able to travel up to 10% of the time, may be higher in accordance with project requirements.
- Computer skills should include proficiency with Microsoft Office suite of software, electronic TMF systems, IRT and EDC systems.
- Excellent understanding of the 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.). The 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.
- Experience in rare disease and/or oncology is preferred.
Physical Demands and Work Environment:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
Travel:
You may be required to travel for up to 10% of your time.
The Anticipated Base Salary Range: $127,000-$169,000
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide 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, and a winter company shutdown.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process
Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Vaccination Requirement:
Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.