Sr. Manager, Clinical Programmer BIOMETRICS
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POST DATE 9/4/2016
END DATE 11/2/2016
Theravance Biopharma US, Inc.
South San Francisco, CA
JOB DESCRIPTIONThe Clinical Programming Senior Manager will be responsible for clinical data programming tasks that support clinical drug development programs.
The position requires a broad, comprehensive and detailed knowledge of statistical programming languages and software, filing support, clinical trial databases, and pharmaceutical drug development process. The incumbent will assist the head of Clinical Programming to develop, recommend, and implement standard procedures, measures of performance, and training programs. Serve as Principle Analyst on programs to organize and allocate resources according to multi-project requirements and deadlines. Provide leadership to the company in the area of technical expertise.
Duties and Responsibilities
The duties and responsibilities include but are not limited to the following:
Act as principal analyst to provide clinical programming services
Develop, revise, and maintain Standard Operating Procedures and Work Instructions
Support the Head of Clinical Programming to achieve the corporate objectives
Stay abreast of current regulatory environment focusing on data and submission standards
Provide input in the selection of CROs, manage CRO programming activities
Lead task forces to develop complex, technical solutions for projects or business needs
Independently bring technical solutions to the Clinical Programming group
Develop and maintain good communications and working relationships with internal/external functions
Ensure that the company business needs and partner organizations are satisfied within agreed-upon timelines with respect to clinical programming activities and the exchange of data sets for clinical studies
Lead the effort of programming process improvement
Assist in validating software products used by the Biometrics department