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.
Creates and maintains documentation for the project:
- Develops study-specific Data Management Plan along with supporting DM documents, such as CRF Completion Guidelines, Trial Design Document, Edit Specifications, Reconciliation Guidelines, and Report Specifications.
- Provides and/or maintains relevant data management documentation for filing in the Trial Master file.
- Develops Project Specific SOPs/Work Instructions (Wis) (as directed by PM or Director, DM).
Works closely with a wide range of clients and internal colleagues on behalf of the business and supports the bid defense process. May support regulatory and sponsor audits, as required.
Position Qualifications:
Education: Bachelor’s degree in related field, or equivalent knowledge and experience.
Experience:
- Seven plus years of clinical data management experience in pharmaceutical industry and/or contract research organization.
- Extensive experience as a Lead Data Manager.
Required Skills:
- Team player with ability to learn new things and teach others.
- Ability to work well with technical and clinical team members and collaborate with entire clinical team (CRAs, Safety, Bios, etc.) and maintain positive and open relations with internal, sponsor, and vendor team members.
- Ability to facilitate team meetings.
- Knowledge of clinical trials concepts.
- Ability to create detailed DM project instructions and documents (CRF guidelines, trial design document, edit check specifications, data review plan, etc.).
- Proficiency with data processing systems (EDC systems, preferably RAVE).
- Proficiency with Catalyst SOPs, WPs for general and DM operations.
- Solid understanding of Good Clinical Practices and relevant regulatory guidelines.
- Familiarity with CDISC standards.
- Efficient with organizational skills to meet deadlines.
- Organized and thorough with attention to detail.
- Excellent presentation skills.
- Effective interpersonal skills and excellent communications skills, verbal, written and listening.
- Ability to accept constructive criticism.
- Effective logical thinking ability regarding problem-solving skills.
- Proficiency in computer applications and time management tools (Excel, Word, Outlook, Project, etc.).
- Ability to travel for meetings or training activities.
Working Conditions: General office working conditions apply. Employee may be office or home based.
Originally posted on Himalayas
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