Lead Data Manager

Brio Group; Pennsylvania; Hybrid; USD 120,000 - 180,000; Full time

Job summary

Brio Group is seeking an experienced Lead Data Manager in the Greater Philadelphia, PA area. The role focuses on independently leading clinical data management activities across assigned studies, from start-up to database lock, ensuring high-quality, inspection-ready trial data.

The Lead Data Manager will serve as the primary DM contact for studies, collaborating with Clinical Operations, Biostatistics, Programming, CROs, and external vendors to drive data integrity and timely delivery.

Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, or related field.
• 5–7+ years of clinical data management experience.
• Experience leading data management activities at study level.
• Familiarity with CDASH, SDTM, GCP, ICH, and FDA regulations.
• Experience managing CROs and external vendors.

Responsibilities

• Lead end-to-end data management from study start-up through database lock.
• Develop and maintain Data Management Plans, CRF guidelines, edit check specifications, and study documentation.
• Lead EDC setup, UAT, database changes, data review, query management, and data cleaning.
• Oversee external data integrations and reconciliation (labs, ECG, imaging, PK/PD, ePRO).
• Manage CRO and vendor deliverables, timelines, data quality, and issue resolution.
• Track study metrics and mitigate data-related risks or delays.
• Lead database lock planning and execution with cross-functional teams.
• Ensure compliance with GCP, ICH, regulatory requirements and SOPs.
• Contribute to data management process improvements, tools, and templates.
• Mentor junior Data Management team members as needed.

Skills

Leadership

Data management

Cross-functional collaboration

Regulatory knowledge

Data quality

Education

Bachelor's degree in Life Sciences or related field

Tools

Medidata Rave

Oracle InForm

Veeva CDMS

Job description

Location: Greater Philadelphia, PA | Hybrid – 3 days onsite per week

A growing biopharmaceutical company is seeking an experienced Lead Data Manager to independently lead clinical data management activities across assigned studies. This individual will oversee the full data lifecycle from study start-up through database lock, ensuring high-quality, accurate, and inspection-ready clinical trial data.

The Lead Data Manager will serve as the primary Data Management contact for assigned studies, partnering with Clinical Operations, Biostatistics, Programming, CROs, and external vendors.

Key Responsibilities

• Lead end-to‑end clinical data management activities from study start‑up through database lock.
• Develop and maintain Data Management Plans, CRF guidelines, edit check specifications, and study documentation.
• Lead EDC setup, UAT, database changes, data review, query management, and data cleaning.
• Oversee external data integrations and reconciliation, including labs, ECG, imaging, PK/PD, and ePRO.
• Manage CRO and vendor deliverables, timelines, data quality, and issue resolution.
• Track study metrics and proactively identify and mitigate data‑related risks or delays.
• Lead database lock planning and execution in partnership with cross‑functional teams.
• Ensure compliance with GCP, ICH, regulatory requirements, and applicable SOPs.
• Contribute to data management process improvements, standards, tools, and templates.
• Provide guidance or mentorship to junior Data Management team members as needed.

Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, or related field.
• 5–7+ years of clinical data management experience within pharmaceutical or biotechnology environments.
• Demonstrated experience independently leading data management activities at the study level.
• Strong experience with EDC platforms such as Medidata Rave, Oracle InForm, or Veeva CDMS.
• Knowledge of CDASH, SDTM, GCP, ICH, and FDA regulatory requirements.
• Experience managing CROs, vendors, study timelines, and deliverables.
• Strong organizational, analytical, problem‑solving, and cross‑functional communication skills.

Preferred Experience

• Data Management leadership for global Phase II or III clinical trials.
• Experience managing multiple external data sources and vendors.
• Experience supporting regulatory inspections or sponsor audits.
• Familiarity with data review and visualization tools such as JReview, Spotfire, or SAS listings.
• Experience with complex data models or adaptive trial designs.