Senior Manager, Clinical Data Management

Company: Bevov
Location: Oakland
Posted on: October 17, 2020

Job Description:

Position Overview: We're looking for an excellent Senior Manager, Clinical Data Management to join our client's dynamic team in South San Francisco who independently leads the data management components of a clinical trial ranging from small early phase to large global and late phase programs.

Responsibilities: Serve as the primary data management liaison with vendors and senior management

Maintain effective communication with vendors and company’s internal project team through oral and written correspondence, project status and progress reports

Manage the planning, implementation and overall direction of executing clinical trial data management activities including protocol review, electronic system configuration, Case Report Form (CRF/eCRF) design, database development, validation programming, and discrepancy management

Design, produce and distribute standard and customized status, resourcing, and tracking reports as well as functional area plans, to appropriate team members and senior management

Oversee and manage the interaction with data management vendors to ensure that data management tasks remain on target according to project timelines

Manage the clinical study budget, ensuring the project remains within scope and that out of scope activities are identified and handled appropriately

Contribute to the development and implementation of departmental policies, standards and process improvement initiatives

Qualifications and Skills: A bachelor's degree in clinical, biological or mathematical sciences, nursing degree, or equivalent related field education and experience is required. A master's degree is preferred

A minimum of 10 years actively managing clinical research projects in collaboration with other functional areas with at least 4 years successfully managing CROs is preferred

Previous supervisory, oncology and/or central nervous system experience is preferred. A thorough knowledge of FDA regulations, drug development and clinical monitoring procedures is required

Demonstrated problem solving abilities and strong presentation, documentation, organizational, and interpersonal skills as well as a team-oriented approach are required

Excellent written and verbal communication skills are required. Demonstrated proficiency with ICH, GCDMP, and GCP is required

Proficient computer skills using Word, Excel, PowerPoint, MS Project, email and the internet are required

Must possess excellent project management skills and have demonstrated ability to develop data management processes and training. Previous people management experience is preferred

Benefits: Company offers competitive salary commensurate with candidate’s experience, and an excellent benefits package including company 401K plan, full medical, dental, vision and paid time leave.

Keywords: Bevov, Oakland , Senior Manager, Clinical Data Management, Other , Oakland, California