Clinical Data Manager
We are currently searching for a Clinical Data Manager to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Rockville, MD
Duties & Responsibilities
- Oversee the Division’s sponsor Clinical Data Management activities and project timelines on
- multiple complex interventional clinical trials networks operating in a global setting.
- Oversee technical service providers performing core data management functions including but not limited to CRF/edit check development, user acceptance testing, data cleaning, listings review, data freeze, and database lock procedures.
- Responsible for the oversight of clinical data management deliverables.
- Evaluate and mitigate clinical data management-related risks across programs on behalf of the Division.
- Conduct data reviews.
- Review the development of database specifications, validation plans, and data management
- plans, ensuring alignment with case report forms, protocol, and safety data standards.
- Apply expert knowledge of regulations governing interventional clinical trials data collection, processing, and systems as evidenced by: proficiency in CFR 21 Part 11, GAMP5, ICH E6 R2, ISO, and any additional regulatory requirements and guidance for data management and electronic information systems for clinical trials, CDISC requirements, ICH Good Clinical Practice (GCP), and Good Clinical Data Management Practices (GCDMP) into routine oversight functions.
- Utilize expert technical knowledge and experience in developing and overseeing systems-development approaches and systems integrations for complex global interventional clinical trials data management requirements.
- Lead and participate in cross-functional data management-related process initiatives or working groups on behalf of the Division.
- Perform project management of multiple ongoing data management activities.
- Responsible for overseeing the end-to-end clinical data management-related activities and is the ultimate accountable person for the data management deliverables in terms of quality and delivery according to plan.
- Provide technical leadership for and oversight of clinical data management activities, including:
- implementation of data management aspects of clinical protocols and data collection systems
- strategic input into proposal or protocol design focused on data management considerations;
- mitigation of potential data management issues by reviewing protocols or other documents for cross-project consistency and identifying standard case report form modules to meet objectives;
- reviewing data management activities and recommending process improvements; and,
maintaining high-level oversight on data quality metrics and data management deliverables.
- Master’s degree in Clinical Sciences, Biological Sciences, or related field is required.
- Minimum of fifteen (15) years of relevant experience.
- Experience with extensive data reporting, data specifications, validations and data planning.
- Project management experience or experience managing timelines highly desired.
- Strong verbal and written communication skills.
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.
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