Sr. Manager, Clinical Data Management
Position Overview
The Senior Manager, CDM oversees clinical data management activities across multiple studies from study start-up through study closure. This includes prioritizing projects in support of corporate goals and objectives and developing and/or enhancing data management processes to ensure complete, accurate, high quality clinical data and adhering to Good Clinical Practices and FDA regulations. Job duties:
- Develop and implement SOPs to ensure GCP/ICH compliance for data management, database operations, clinical report writing, case report forms, and associated procedures.
- Participate on corporate global clinical research teams ensuring that colleagues are updated on all relevant issues.
- Assist in budget planning and resource allocation as it relates to data management.
- Develop and implement clinical trial database, including CRF development and all aspects of data management.
- Manage, plan, and coordinate the activities of the data management team members.
- Oversee data management vendors, ensuring requirements are met and consistent.
- Audit data management vendors, as appropriate.
- Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and other applicable regulations and guidelines.
- Review and approve CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements and data management plans.
- Review study documents, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells.
- Participate in the development of EDC User Acceptance Test (UAT) and custom report specifications as needed.
- Plan, manage and coordinate all data management activities to ensure consistency of clinical data process across studies.
- Work collaboratively with biostatistics, programming and other functions to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.Contribute to activities supporting audits & inspection readiness and regulatory inspections.
- Performs additional responsibilities as assigned.
- Bachelor’s degree in Science, Computer Science, or equivalent combination of training and experience.
- Minimum seven (7) years of clinical data- management experience in the pharmaceutical, device or CRO setting.
- Previous supervisory experience.
- Proven ability to prioritize and manage multiple tasks with conflicting deadlines in support of corporate goals and objectives.
- Experience reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans, Data Transfer Plans.
- Well organized, analytical and self-confident person.
- Solid experience in developing, implementing, and validating data management systems and Electronic Data Capture (EDC).
- Strong communication skills and interpersonal skills, ability to coach and mentor.
- Knowledgeable in GCP standards, FDA and ICH guidelines, and recommended CDM Best Practices.
- Hands-on extensive knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission.
- Able to work independently, as well as part of a team.