Director, Clinical Data Management (EDS)
Full Time
San Diego, CA 92121
Posted
Job description
POSITION SUMMARY:
As the subject matter expert for the handling and management of laboratory and other external data types, the Director, Clinical Data Management will serve as the Head of the External Data Solutions (EDS) team and oversee all data management activities associated with the management and transfer of data from external vendors.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
- Act as representative of the inter-department subject matter expert for EDS for all trials to enable planning, coordination, and timely delivery of complete, high quality, and reliable clinical trial data for internal decision-making, regulatory approval, and market acceptance
- Serve as a key contributor to evaluate, implement, and lead process and infrastructure development/improvement. This may include external vendor management and development, system evaluations and selections, external data integrations, and adhering to end-to-end data standards
- Ensure all external data comply with Data Transfer Specifications (DTS), standards, protocols, SOPs and overall clinical objectives. Help ensure the continued development, review and updating of SOPs and process documentation in accordance with corporate, industry and regulatory agency standards
- Assist with implementing the corporate strategic plan within the department – planning and managing internal and external EDS resources, and assisting with managing the department budget
- Provide strategic, organizational, and operational management and guidance to the personnel and teams within EDS.
- Provide technical and functional oversight of the day-to-day work and work products of EDS clinical data management staff, as needed, including clinical data collection, processing, quality control procedures, timelines, and documentation
- Assist with the selection and management of data management vendors; identify potential risks, resolve issues with CROs; oversee vendor management plans and review quality metrics; provide guidance, and monitor the progress of DM activities with CROs or other vendors
- Contribute to identifying, locating, evaluating, and validating CDM documents, data transfer processes and infrastructure, and databases required for report generation or regulatory submission
- Assist with the coordination of non-routine projects, as applicable, in support of Development initiatives
- Collaborate with cross functional peers to facilitate and optimize the product development and registration process
- Other duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
- Bachelor’s degree in life sciences, computer, statistics, etc. or equivalent combination of a bachelor’s degree and relevant job experience. Graduate degree is preferred but not required
- At least 12 years of relevant data management experience, including at least 5 years leading the management of external data, and at least 8 years of managerial experience leading CDM teams in the biotech, pharmaceutical, medical device or CRO industry, including experience in multiple therapeutic areas and in various phases of drug development.
- Experience leading CDM infrastructure setup & deployment and CDM process improvement
- Experience on CRO selection and oversight as well as management
- Knowledge of the current industry best practices, FDA and ICH regulations, ICH-GCP, GCDMP and other applicable local and international regulations
TECHNICAL KNOWLEDGE REQUIRED:
Experience in clinical trial data collection systems (EDC, eCOA, CTMS, Drug Safety Database Systems, IVRS/IXRS, reporting tools, data visualization, etc.) and practical knowledge of data integration between data collection systems.
Detailed knowledge of data standards (CDISC, CDASH, SDTM) in the clinical environment
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
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.
TRAVEL:
Travel may be required up to 5% of your time.
THE ANTICIPATED BASE SALARY RANGE: $110,000 - $210,000
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 in December.
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.
ABOUT CRINETICS:
Crinetics Pharmaceuticals Inc. (www.crinetics.com) is a rare endocrine disease and endocrine-related cancer therapeutics company. Crinetics’ benefit package includes health insurance, stock options, ESPP, a 401k, paid time off, and the company provides a dog-friendly work environment.
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