What are the responsibilities and job description for the Sr. Manager, Clinical Data Management position at Terumo Neuro?
Job Description
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:
US - United States
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.
US - United States
