Crinetics Pharmaceuticals

Senior Manager, Clinical Data Management - External Data Management

Remote, USA · Senior

Sponsorship not specified$138k-$172kDetected 83 days ago

GCPData VisualizationStatisticsProcess ImprovementSASAnimal StudiesLeadershipBiostatistics

About the role

The Senior Manager, Clinical Data Management - External Data Management (CDM‑EDM) is a hands‑on, individual contributor role responsible for executing and owning external (non‑EDC) data management activities for assigned clinical studies.
This position focuses on direct execution and plays a critical role in ensuring external vendor data are timely, high quality, inspection‑ready, and fit for statistical analysis and regulatory submission.
Essential Job Functions and Responsibilities:

Develop and maintain Data Transfer Agreements (DTAs) and external data specifications for each external data source (e.g., central labs, PK/biomarkers, ECG, imaging, eCOA, IRT and CTMS).
Coordinate and perform test data transfers, including hands‑on QC and approval prior to production data flow.
Establish and manage external data transfer schedules and reconciliation cycles aligned with study milestones.
Import, validate, and reconcile external datasets to ensure completeness, accuracy, and consistency.
Perform ongoing external data cleaning and reconciliation, including discrepancy identification, issue investigation, and resolution with vendors.
Utilize tools such as SAS (or similar) and data visualization systems to support data review, validation, and reconciliation activities.
Serve as the primary external data contact for vendors and CRO partners.
Act as the external data management lead on study teams.
Collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Safety, and Regulatory teams to ensure data readiness for analyses, reviews, and submissions.
Maintain complete and inspection‑ready documentation, including DTAs, data transfer logs, reconciliation records, and external data management plans.

Some walking and lifting up to 25 lbs. may be required.
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.
You may be required to travel for up to 5% of your time.
Alternatively, 12 years of progressive clinical data management experience is required if individual possessed a Bachelor's degree only.
Strong working knowledge of EDC systems, external data transfers, CDISC standards (CDASH/SDTM), and clinical data regulations.
Proficiency with hands‑on SAS experience (or equivalent) for data validation, reconciliation, and issue investigation.
Demonstrated ability to work independently with minimal oversight while managing multiple priorities, timelines, and stakeholders.

Experience supporting late‑phase and/or submission‑supporting studies, with ownership of external data readiness for analyses and regulatory milestones.
Experience contributing to process improvement initiatives under senior CDM leadership (e.g., SOPs, templates, inspection‑readiness practices).
Background or exposure to laboratory operations and/or bio-sample management, including lab data flows and reconciliation considerations.
Professional certification such as CCDM or equivalent.

Work directly with vendor data management teams to troubleshoot issues and ensure timely, high‑quality data delivery.
Monitor vendor performance related to data quality and timelines and escalate issues as needed.
Ensure all external data activities comply with ICH‑GCP, 21 CFR Part 11, CDISC standards, and internal SOPs.

The salary range for this position is: $138,000 - $172,000.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.

MS/BS degree in life sciences, health informatics, computer science, or a related field.
Environmental health and safety requirements also apply.
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.

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.
Crinetics is known for its inclusive workplace culture.
We are also a dog-friendly workplace.
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.

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.

tation, 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 s

This listing is sourced directly from Crinetics Pharmaceuticals's careers page and normalized into a canonical job model.