Project Data Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead studies within a designated program.

• Supervise data managers and CRO/FSP resources involved in assigned studies.

• Actively participate as a member of Clinical Study Teams.

• Collaborate across functions to create timelines and ensure adherence to clinical data management deadlines.

• Define specifications for external data transfers and collaborate with outside vendors.

• Review and reconcile laboratory data with the established normal ranges.

• Develop or oversee the creation of eCRF and edit check specifications.

• Work alongside database builders on EDC databases, edit checks, and reports.

• Lead and conduct User Acceptance Testing for clinical trial database builds and modifications.

• Develop or supervise the creation of study-specific eCRF Completion Guidelines and Data Management Plans.

• Create and maintain documentation related to data management.

• Ensure that data cleaning activities align with Data Validation Specifications and Data Management Plans.

• Coordinate with coding teams regarding clinical study coding.

• Define listings necessary for data management, clinical, and medical reviews.

• Identify and resolve operational issues by utilizing metrics, audit reports, and input from project teams.

• Lead data review activities and escalate potential data concerns to the LDM.

• Train staff on eCRFs and EDC as required.

• Collaborate with Pharmacovigilance on the reconciliation of serious adverse events.

• Review and provide insights on protocols, Statistical Analysis Plans, CSRs, and other relevant documents.

• Support process improvement initiatives and the development and maintenance of SOPs and work instructions.

• Work with program leads and various functions to ensure timely and high-quality data delivery.

• Mentor junior Clinical Data Managers as necessary.

• Perform additional duties as assigned.

⛳️ Requirements

• Minimum of 6 years of experience in clinical data management within the pharmaceutical or biotechnology sector.

• Experience in oncology is preferred.

• Ability to thrive in cross-functional, team-oriented environments.

• Knowledge of ICH and regulatory frameworks relevant to data management.

• Proficient in SDTM/CDASH standards.

• Strong project management abilities.

• Excellent written, verbal, and organizational skills.

• Detail-oriented with a high level of accuracy.

• Proficient in computer applications, including Microsoft Office.

• Familiarity with at least one EDC system; Medidata Rave is preferred.

• Willingness to travel domestically and internationally as needed.

• Bachelor's degree or equivalent in a health-related discipline is preferred.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Participation in an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan.

• Flexible Spending Account/Health Savings Account options.

• Life insurance coverage.

• Paid Time Off.

• Wellness benefits.

• Reasonable accommodations for individuals protected by relevant laws.