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Sr. Manager, Clinical Data Management (SOP Development)
Ref No.: 18-13543
Location: San Francisco, California
Skilled leading the data management components of a clinical trial ranging from small early phase to large global and late phase programs. Accountable for development of SOPs and working practices to enhance the Data Management quality framework. Must be familiar with industry Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. Duties include serving as the liaison for data management with cross-functional partners and senior management. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Exercise judgment in managing tasks within generally defined practices and policies in selecting methods and techniques to track and manage timelines, risk, and data quality. Maintain effective communication with management and Nektar's internal stakeholders through oral and written correspondence, project status and progress reports. Independently manage the planning, implementation and overall direction of developing and implementing working processes for clinical trial data management activities including contractual arrangements with vendors, protocol review, electronic system configuration, Case Report Form (CRF/eCRF) design, database development, validation programming, and discrepancy management.

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. Fluent English is required. Proficient computer skills using Word, Excel, PowerPoint, MS Project, email and the internet are required. Demonstrated self-starter with the ability to mentor and handle multiple tasks to meet deadlines while delivering high quality work in a dynamic work environment. Must possess excellent project management skills and have demonstrated ability to develop data management processes and training.