Associate Manager, Clinical Data Management

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

📋 Description

• Oversee data management processes for clinical studies from initiation to database lock.

• Assume responsibility for project documentation, system configuration, data entry, and validation procedures.

• Collaborate directly with Sponsors to comprehend and fulfill their requirements.

• Lead studies involving healthy volunteers and patients, multi-site research, client management, or expedited timelines.

• Organize and prioritize tasks and deliverables effectively.

• Manage DM deliverables, guide study teams, review outputs, and adjust resource allocations as necessary.

• Ensure adherence to protocols, globally harmonized SOPs, and GCP standards across projects.

• Develop project timelines with Project Managers to achieve contracted milestones.

• Facilitate data-centric internal project meetings and coordinate deliverables with EDC Design, SAS Programming, Statistics, and PK teams.

• Identify risks and mitigation strategies, engage in data-driven discussions, and support database lock timelines.

• Keep Project Managers, Biometrics management, and sponsor services updated on project status, budgets, scope modifications, and timeline changes.

• Cultivate client relationships and assess client satisfaction through surveys.

• Monitor scope alterations and secure Sponsor approvals.

• Provide leadership, mentorship, coaching, and constructive feedback to members of the study team.

• Acquire and implement new DM technologies and processes for enhanced efficiency.

• Maintain precise work records.

• Reconcile clinical databases with safety, laboratory, and third-party data.

• Utilize local laboratory systems and batch data loading facilities as appropriate.

• Represent Data Management and Biometrics in new business pursuits.

• Participate in client or internal audits and address any issues that arise.

• Address client feedback in collaboration with the study team.

• Promote Biometrics services to sponsors.

• Perform additional duties as assigned.

⛳️ Requirements

• University or college degree; relevant and equivalent experience may be accepted in place of formal education.

• Relevant work experience and/or education that equals a bachelor's degree may substitute for the degree requirement.

• Proficiency in English, both written and spoken.

• Approximately 3 years of experience in a primary data management role within complex in-house studies, or over 5 years of hands-on data review and reconciliation support.

• 6 to 8 years of DM experience, including at least 1 year in direct sponsor management.

• Experience with in-house study initiation, execution, and closure.

• Ability to create/update Data Management Plans, eCRF Completion Guidelines, Data Review Plans, SAE Reconciliation Plans, and Edit Check Specifications.

• Conduct User Acceptance Testing (UAT) of EDC databases and data validation listings.

• Expertise in complex external data reconciliation including eCOA, PK, local lab ranges, and Biomarkers.

• Perform data cleaning in EDC.

• Raise queries in EDC based on findings from monthly cross-functional data reviews.

• Maintain an issue log for tracking purposes.

• Upload documents to the electronic Trial Master File (eTMF).

• Generate metrics reports during team meetings.

• Experience with protocol deviation reconciliation.

• Familiarity with database lock procedures.

• Excellent communication skills.

• Capacity to work on fast-paced studies.

• Knowledge of clinical trial processes, data management, clinical operations, biometrics, and system applications.

• Strong time management skills and ability to meet project productivity metrics and deadlines.

• Understanding of medical terminology.

• Minimum 3 years of experience with Electronic Data Capture.

• Previous experience with Veeva EDC is advantageous.

• Preferred degree in life sciences, health sciences, information technology, or a related field.

• A scientific background or knowledge in science is preferred.

• Comprehensive understanding of Fortrea organization and SOPs is preferred.

• Availability for overtime and weekend work may be required.

• Willingness to work flexible shifts as needed.

🏝️ Benefits

• Medical coverage.

• Dental insurance.

• Vision care.

• Life insurance.

• Short-term and long-term disability insurance.

• 401(K) retirement plan.

• Paid time off (PTO) or Flexible time off (FTO).

• Company bonus where applicable.

• Flexible shifts based on business needs.

• Work environment options include office and home-based settings.