Senior Data Manager

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.  

Position Summary: As the Senior Data Manager (Sr. DM) you are a key member of the Development Operations, Data Management Team. The Sr. DM serves as a key member of project teams, responsible for managing all data management tasks from project start-up to database lock, to produce a clean and analyzable database. The Sr. DM will work closely with the Manager and/or Director, Data Management to support the data management capabilities and processes within Catalyst to provide efficient data management to clinical study teams.

Position Responsibilities:

Manages a Data Management project:

• Provides/oversees DM services for multiple and/or complex clinical trials.
• Serves as DM lead (LDM) for internal/client team meetings and communications.
• Produces and reviews metric reports for internal/external project teams.
• Has ownership of project deliverables within DM scope of services, including projections.
• Discusses roadblocks and solutions for completing project objectives in a timely manner.
• Reviews project budgets and staffing needs for data management activities, including providing input into project forecasts and achieved milestones/units.
• Identifies and manages activities outside of the scope of services for assigned projects.
• Provides training for other DM staff on project specific processes.
• Ensures adherence to GCP, regulatory guidelines and standard operating procedures.
• Manages database lock, transfer and CRF archiving for assigned projects.
• Manages client relationships.

Clinical Data and Query Review:

• Creates the Data Quality Review Plan and coordinates cross-functional input from project team.
• Defines the DM listings using ad hoc query tools.
• Reviews clinical and external vendor data to ensure a high degree of quality.
• Performs data review. Issues queries and reviews responses with the highest level of quality based upon the Data Review Specifications, Aggregate Checks (DM listings), Reconciliations (LAB, SAE, ECG), other reviewers (Biostatistician, Medical Monitor, Client), and ad hoc reports.
• Coordinates medical coding activities.
• Manages the processing of local laboratory data for studies and addresses inconsistencies with sites and CRAs as applicable.
• May assist in review of subject validity/population adjudication.
• Monitors data quality and integrity, ensuring compliance with company and regulatory standards.

Oversees System Development and Modifications:

• Drafts the CRF design, edits check specification and DM listings specifications.
• Facilitates clinical team review of system documents (CRFs, Edit Checks, Data Review Plan, etc.)
• Consolidates comments from internal team/sponsor for discussion and approval.
• Ensures all non-DM activities related to database development are completed in a timely manner.
• Manages all database modifications for DM activities.
• Oversees and performs the validation of CRF system (CRF content & edit checks), reports using EDC Reporting, and associated change control requests.
• Provides feedback to the other project team members and managers to improve the deliverables.

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