Senior Manager, Clinical Data Management (Technical)
Categories: Biometrics
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 Senior Manager, Clinical Data Management, will be responsible for all clinical data management activities and deliverables for the assigned study/studies in accordance with ICH/Good Clinical Practices (GCP), GDCMP and other relevant regulations, procedures, and guidelines. The responsibilities of this position include but are not limited to vendor service oversight, vendor invoice verification, budget contract negotiations and management, being the subject matter of expert of data management to provide guidance and suggestions to vendor and the study team for all data management deliverables and timelines from study start-up through study close-out, final reporting, and data archiving.
The Senior Manager will be involved in development of SOP(s), data standards and standardization, managing and leading the ongoing practices in DM processes with internal study resources and/or vendors for the responsible study/studies and driving for DM deliverables and operation excellence.
The Senior Manager will also partner and collaborate with other functional groups and external vendors to ensure timelines and quality of project deliverables of the responsible study/studies.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
- Manage the assigned study/studies and make expert recommendations and/or decisions that ensure timelines and deliverables.
- Collaborate cross-functionally to resolve clinical data issues and ensure effective communication throughout the drug development process.
- Resolve and/or escalate issues encountered at the study level and ensures the performance of the data management function.
- Provide effective CRO/vendor oversight to ensure requirements are met and the project plans are executed to meet the development needs.
- Leverage data management and related expertise to promote best practices across the drug development lifecycle and enhances collaboration with relevant stakeholders.
- Contribute to team building and best practices to achieve the defined data quality with cost efficiency.
- Participate in regulatory audit and/or company initiatives.
- Responsible for performance of the function for the assigned study/studies
Education and Experience:
- Master’s with 8+ years of experience, or Bachelor’s with 10+ years of direct data management experience, in life sciences or related field, and at least 3 years of CRO oversight experiences. In depth knowledge of clinical data management in the Biotech, Pharmaceutical or CRO industry.
- Strong project management skills and experience working with CROs/vendors
- Demonstrated organizational and interpersonal skills.
- Detail oriented with excellent communication skills and extensive experiences working in cross-functional setting.
- Highly experienced in CDISC standards, SDTM requirements, and CFR-Part 11 Compliance
- Knowledge of GCP, ICH and other regional regulations and compliance
- Experience with clinical data lifecycle from database set-up and maintenance to database lock and archiving
- Working knowledge of current technologies in clinical trial data collection systems. Competence in Excel and/or SAS programming is a big plus
- Knowledge in current data collection technologies and integration (EDC, eCOA, CTMS, Drug Safety Database Systems, IVRS/IXRS).
- Skills in EDC building 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.
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 5% of your time.
The Anticipated Base Salary Range: $131,000-$174,000
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.
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.
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.