Senior Manager, Clinical Data Management - External Data Management

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.

Position Summary:

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.

The role partners closely with external vendors, CROs, and internal cross‑functional stakeholders to set up data transfer agreements (DTAs), validate test files, manage ongoing data transfers, and perform data reconciliation and quality control activities in compliance with ICH‑GCP, 21 CFR Part 11, and internal SOPs.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• 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.
• 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.
• Act as the external data manag