TMF Specialist
Categories: Clinical Operations
Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. 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 TMF Specialist will provide subject matter expertise (SME) and support required to ensure that the Trial Master File (TMF) is audit and inspection ready. This individual will ensure the TMF is managed in accordance with relevant regulations, ICH/GCP guidelines, and SOPs.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
- Provide TMF oversight to study teams, including external partners and CRO staff, to ensure that TMF activities are being conducted per SOPs and to Crinetics standards.
- Serve as the TMF liaison between the clinical study teams, CRO staff, and eTMF vendor personnel.
- Perform routine and ad hoc quality and/or completeness checks in the TMF, focusing on identifying issues and trends with completeness, quality, and/or timeliness.
- Provide regular updates at study team meetings on TMF health, including relevant TMF metrics and any areas of concern.
- Assist the Director, Clinical Systems and Processes with the development of functional policies, procedures, and training focused on increasing efficiency and quality of deliverables.
- Generate and maintain study-specific TMF management plans and contents lists in collaboration with functional/sub-functional area study team members.
- Maintain awareness of study events and associated documentation requirements through collaboration with functional/sub-functional area study team members.
- Support/train functional/sub-functional area study team members in understanding their TMF-related responsibilities, requirements, and expectations.
- Liaise with study teams, staff, and eTMF vendor personnel to ensure optimal relationships.
- Other duties as assigned.
Education and Experience:
Required:
- Bachelor’s Degree with 2 years of experience working in a clinical research (clinical operations) environment with 2+ years of direct “hands-on” TMF experience.
- Veeva Vault eTMF experience preferred.
- Strong knowledge of ICH/GCP guidelines, TMF Reference Model/CDISC, and global regulatory requirements as they pertain to the management and inspection of the TMF.
- Excellent planning, organizational, and time management skills, including the ability to support and prioritize multiple projects.
- Demonstrated experience or knowledge with the clinical research process, including the collection of documents at study start-up, during study conduct and close-out.
- Extensive knowledge of clinical trial documents that are maintained in the eTMF.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
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: $68,000-$90,000
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.