Sr. Manager, Clinical Data Management

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 :

• 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.

Qualifications

Desired Qualifications