Senior Manager, Clinical Data Management – EDS
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:
As the experienced data manager for the systematic handling and management of laboratory and other data types from the external vendors. The individual in this position will be the key player supporting the External Data Solutions (EDS) and implementing the systematic processes for data management activities associated with the External data acquisition and data validation.
As the experienced data manager for the systematic handling and management of laboratory and other data types from the external vendors. The individual in this position will be the key player supporting the External Data Solutions (EDS) and implementing the systematic processes for data management activities associated with the External data acquisition and data validation.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
These may include but are not limited to:
- Serve as a key contributor to evaluate, implement, and lead the process and infrastructure development/improvement in the scope of external data acquisition and data validation. This may include external vendor management, 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.
- Provide technical support and functional oversight of the day-to-day work and work products of EDS in clinical data management, 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 EDS activities with vendors.
- Implement the data acquisition and validation solutions for systematic data management of the external vendor data.
- 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.
Education and Experience:
Required:
Required:
- Master’s with 8+ years of experience, or Bachelor’s with 10+ years of direct data management experience, in life sciences or related field.
- At least 10 years of programming, especially SAS programming, and relevant data management experience, including management of external data, implementing systematic data acquisition, validation and reporting in the biotech, pharmaceutical, medical device or CRO industry.
- Experience in CDM infrastructure setup & deployment, system integration and CDM process improvement. Experiences in eCOA, IRT/EDC integration are highly valued.
- Experience in Ext data validation process and automation are big plus.
- Experience on CRO management.
- Knowledge of the current industry best practices, FDA and ICH regulations, ICH-GCP, GCDMP and other applicable local and international regulations.
Preferred:
Graduate degree is preferred but not required.
Graduate degree is preferred but not required.
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.
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.
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.