Senior Clinical Data Manager - Katalyst Healthcares & Life Sciences
Princeton, NJ 08540
About the Job
Responsibilities:
- Coordinate and oversee the external lab data reconciliation process, ensuring that all laboratory data is correctly integrated into the clinical database.
- Liaise with external vendors and laboratory teams to resolve discrepancies and ensure data accuracy.
- Perform QC checks to confirm that external data aligns with study-specific requirements.
- Oversee the LNR reconciliation process by managing the collection, integration, and validation of local lab data.
- Work closely with site and data management teams to resolve discrepancies and ensure data completeness.
- Lead data cleaning efforts, ensuring the integrity, consistency, and accuracy of the clinical trial data.
- Oversee data review processes, including identifying discrepancies, missing data, or protocol deviations, and implementing corrective actions.
- Collaborate with cross-functional teams, including biostatisticians, clinical operations, and regulatory teams, to ensure a seamless data review process.
- Co-lead clinical study data management activities from study setup through to database lock.
- Develop and execute Data Management Plans (DMPs) and database design in collaboration with the study team.
- Ensure adherence to timelines and milestones related to data management deliverables.
- Participate in database design discussions and perform User Acceptance Testing (UAT) as needed.
- Work closely with project managers, clinical teams, and external vendors to ensure data reconciliation processes and study milestones are achieved.
- Serve as the point of contact for data management issues and ensure timely resolution.
- Facilitate regular communication with study team members to provide updates on study progress, timelines, and deliverables.
- Ensure compliance with ICH-GCP, FDA, and other regulatory requirements throughout all study stages.
- Conduct periodic quality control checks to ensure the data management process aligns with both internal SOPs and external regulatory standards.
- Provide audit support and ensure all data management documentation is audit-ready at all times.
- Experience: 7 years of clinical data management experience, with a proven track record in external lab and LNR reconciliation.
- Education: Bachelor's degree in life sciences, clinical data management, information technology, or a related field. An advanced degree is preferred.
- Skills:Expertise in data reconciliation processes for clinical trials (external lab and LNR).
- Strong experience in clinical data cleaning, validation, and quality oversight.
- Familiarity with clinical database platforms (e.g., Medidata RAVE, Oracle Clinical, Veeva).
- Solid understanding of clinical data standards (CDISC, SDTM) and regulatory requirements (ICH-GCP, FDA).
- Demonstrated ability to manage study setup, conduct, and lock processes.
- Key Competencies:
- Self-starter: Demonstrates a high level of initiative and the ability to independently drive projects forward.
- Problem-solving: Proven ability to identify, analyze, and resolve data issues efficiently.
- Attention to detail: High level of accuracy in managing complex clinical data and reconciliation processes.
- Collaboration: Strong interpersonal and communication skills, with the ability to work effectively across functional teams.
- Learning Agility: Willingness and ability to quickly grasp new tools, systems, and processes.
Source : Katalyst Healthcares & Life Sciences