Senior CDM Lead — Remote Contract (Inspection-Ready)

Penfield Search Partners Ltd.; Fairfield (CT); Remote; USD 140,000 - 190,000; Full time

Job summary

Penfield Search Partners Ltd. seeks an Associate Director of Clinical Data Management to lead data management strategy and oversee CRO/vendor partnerships remotely on a contract basis.

The role drives inspection readiness, data integrity, and cross-functional collaboration across biotech programs. You will mentor data managers, coordinate with QA and other functions, and ensure acceptance criteria for data deliverables through database lock and study close-out.

Qualifications

• Bachelor’s degree in a scientific, technical, or clinical discipline; an advanced degree is a plus.
• Typically 8–10+ years of clinical data management experience in biotech/pharma/CRO with program leadership.
• Regulatory inspection experience is required, direct interaction with inspectors preferred.
• Experience leading data management inspection activities and cross-functional communication.
• Hands-on with EDC systems such as Medidata Rave, Oracle, or Veeva; CDISC SDTM/ADaM knowledge.
• Knowledge of GCP and regulatory expectations for data management and vendor oversight.

Responsibilities

• Lead data management strategy and execution across programs from startup to database lock.
• Oversee CROs and vendors; set expectations, review deliverables, resolve issues.
• Prepare data management for upcoming regulatory inspections with QA and other functions.
• Coordinate documentation and responses; manage data requests and inspections follow-up.
• Serve as subject matter expert during inspections, explaining processes and controls to inspectors.
• Mentor Data Managers; provide technical guidance and review deliverables.
• Align data strategies with Clinical Operations, Biostatistics, Medical, Safety, and QA.
• Contribute hands-on to DMPs, eCRF design, edit checks, query logic, and UAT.
• Direct data review, query management, and data reconciliation for data integrity.
• Identify data risks early and communicate status to stakeholders.
• Drive SOPs, data standards, and process improvements for inspection readiness.

Skills

Leadership

Data Management

Regulatory Compliance

Vendor Oversight

Cross-functional Collaboration

Education

Bachelor’s degree in a scientific

Advanced degree

Tools

Medidata Rave

Oracle Clinical

Veeva CDMS

Job description

Penfield Search Partners Ltd. seeks an Associate Director of Clinical Data Management to lead data management strategy and oversee CRO/vendor partnerships remotely on a contract basis.

The role drives inspection readiness, data integrity, and cross-functional collaboration across biotech programs. You will mentor data managers, coordinate with QA and other functions, and ensure acceptance criteria for data deliverables through database lock and study close-out.