The Clinical Data Manager provides accurate, timely, and consistent clinical data to client organizations and internal staff to support business objectives. The Clinical Data Manager defines and directs the data management workflow for assigned projects, ensuring all necessary data quality control measures are in place. The Clinical Data Manager serves as the data management expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables.
· Oversee all data management deliverables for assigned studies
· Adhere to all Synarc Clinical Data Management (CDM) procedures, policies, and work instructions
· Develop and track timelines and ensure CDM project milestones are met in coordination with the project team
· Develop file specifications and support development of reporting and transfer code
· Review data capture and analysis system requirements and configurations including reports
· Create or Review Transmittal Forms for a study, ensuring consistency with existing standards
· Ensure that system bugs and needs for enhancement are reported to the applicable Engineering Product Manager, and that any stop-gap CDM programming is approved
· Define, run, and review edit checks and resolve discrepant data
· Collaborate with other departments to identify and implement data corrections
· Coordinate and document the receipt and processing of electronic or ancillary data received from outside sources (e.g., data received from other central laboratories, CRO's, or Sponsors)
· Create and maintain the Data Management Plan when required
· Answer questions and propose technical solutions specific to data management processes
· Meet regularly with CDM management to discuss and seek resolution to department issues
· Participate in conference calls, Sponsor visits, and audits (internal and external) as needed
· Ensure accuracy in manipulation and scrutiny of clinical data and that CDM activities are carried out according to regulatory guidelines
· Ensure clean and on-time Data and Image Transfers to Sponsor
· Provide updates and study metrics to the Manager, Clinical Data Management
· Maintain documentation of important CDM decisions and current project deliverables in the CDM Tracker
· Escalate potential risks to data quality or timeliness of deliverables to supervisor as soon as they are identified
· Implement study closeout procedures
· Participate in departmental initiatives, including SOP development
Bachelor's Degree in Life Science preferred
2 or more years of CDM experience recommended
High degree of comfort working with relational databases recommended, including: complex queries and joins, file manipulation, table structure, SQL.
Excellent verbal and written command of English.
Strong organizational, inter-personal, and team skills.
Demonstrated contribution in a team based work environment.
Able to prioritize study load and associated tasks.
Self-motivated with ability to work under minimal supervision and aggressive timelines.
Strong attention to detail and ability to take ownership of complex issues, ensuring resolution.
Knowledge of clinical research, GCP, GCDMP, and related regulatory requirements preferred.
SYNARC Inc. - 17 months ago
Synarc enables its clients to demonstrate the efficacy of new therapies across a broad range of therapeutic areas through highly specialized...