Senior Manager, Clinical Data Management - External Data Management

Position Summary: The Senior Manager, Clinical Data Management 6 External Data Management (CDM 9EDM) 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 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.
• Ensure all external data activities comply with ICH GCP, 21 CFR Part 11, CDISC standards, and internal SOPs.
• Support regulatory inspections and audits as the external data management subject matter expert.
• Other duties as assigned.

Education and Experience: Required:

• MS/BS degree in life sciences, health informatics, computer science, or a related field.
• 8+ years of progressive clinical data management experience, including deep, hands on specialization in external (non EDC) data management and direct vendor/CRO execution. Alternatively, 12 years of progressive clinical data management experience is required if individual possessed a Bachelor 9s degree only.
• Demonstrated experience independently managing complex external data across the full clinical data lifecycle (study startup through database lock, regulatory submission support, and archiving).
• Proven expertise serving as the external data subject matter expert on studies with multiple vendors and data streams.
• 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.
• Solid understanding of ICH GCP, 21 CFR Part 11, and regulatory inspection expectations for external vendor data.
• Demonstrated ability to work independently with minimal oversight while managing multiple priorities, timelines, and stakeholders.

Preferred:

• 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.
• BASE SAS Certified Programmer (required or strongly preferred), with demonstrated ability to write SAS programs for external data reconciliation and validation (e.g., conformance checks, cross source comparisons, issue identification).
• Professional certification such as CCDM or equivalent.

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. 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. Salary Range 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. 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. Apply tot his job Apply To this Job