24 Associate Director, Data Management Jobs in Cambridge, MA
Green Key Resources is Hiring an Associate Director, Data Management Near Cambridge, MA
- Manage and supervise a team of Clinical Data Managers (CDMs)
- Oversee each project assigned to the team.
- QC each deliverable prior to being sent to internal or external clients.
- Prepare and present individual performance reviews.
- Provide mentorship to DM staff and suggest/implement solutions for complex issues.
- Assist staff with interactions with sponsors and managing vendors.
- Keep supervisor updated on study progress and staff management through routine meetings.
- Maintain a positive, progressive, and proactive management style and communication!
- Develop and update data management SOPs and training manuals.
- Conduct data management training as well as study specific training for the CDM and study teams.
- Provide input from the data management perspective regarding the design of clinical trial protocols.
- Oversee, develop, and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Postproduction Database Change Control Documentation, Database Audit and Lock Procedures.
- Oversee and participate in the process of data review and query generation procedures.
- Oversee and participate in the coding of medical terms.
- Oversee/define/perform SAE reconciliation processes.
- Work with DM leads and DB programmers to design (e)CRFs and edit checks in EDC system.
- Ensure proper completion of UAT of EDC system and modules.
- Oversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliation
- Review queries and trends to ensure data completeness and integrity.
- Review/prepare training materials and user guides for EDC data collection tools, deliver user training.
- Participate in client and team meetings as required advising on best practices as appropriate.
- Provide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studies.
- Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changes.
- Implement technical solutions, new tools, and process improvement strategies.
- Lead large and complex projects.
- Identification of project scope changes.
- Present at sales and marketing meetings for prospective clients.
- Provide strategic input to the department and company goals.
- Lead key departmental goals and initiative.
- Minimum BS in a scientific or health related field or equivalent
- Minimum of 10 years of experience in Clinical Data Management
- Minimum 2 years supervisory experience is required.
- Knowledge of GCPs and regulatory agency guidelines
- Familiarity with medical terminology is required.
- Skilled in the use of data management software application, Medidata RAVE
- Excellent organizational and time management skills
- Strong collaboration and leadership skills
- Excellent oral and written communication skills
- Strong interpersonal skills
Job Summary
Full Time
Ambulatory Healthcare Services
$190k-232k (estimate)
06/21/2024
08/06/2024
greenkeyllc.com
POTOMAC, MD
500 - 1,000
2004
CHELSEA MURPHY
<$5M
Ambulatory Healthcare Services
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