The Senior Program Data Manager independently leads the data management components of a clinical trial ranging from small early phase to large global and late phase programs. The assigned clinical trial(s) may be high complexity or high risk. The Senior Program Data Manager is accountable for ensuring study launch, conduct, and closeout are performed according to Nektar’s quality standards, 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 primary data management liaison with vendors 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.
Work on problems of a diverse scope. 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 vendors and Nektar’s internal project team through oral and written correspondence, project status and progress reports. Independently 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. Prepare information for internal meetings. Maintain and evaluate project progress by managing timelines and other tracking/analysis tools. 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. Independently manage the cross-functional collaboration, development, and maintenance of the components of the study Data Management Plan (DMP) and data management deliverables including the Case Report Form (CRF), CRF completion guidelines, SAS annotated CRFs, data handling plan, data review plan, edit check specifications, data transfer specifications, data quality plan, etc. Oversee and manage the interaction with data management vendors to ensure that data management tasks remain on target according to project timelines. Proactively organize on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies. Facilitate the correction of errors and discrepancies through the site query process, document permanent data issues, communicate issues with team members, and deliver a quality locked database for analysis. Manage the clinical study budget, ensuring the project remains within scope and that out of scope activities are identified and handled appropriately. Lead new data management initiatives such as establishing capacity for electronic data capture and clinical outcome assessments. Conduct CRO data management function inspections and audits. Contribute to the development and implementation of departmental policies, standards and process improvement initiatives. May mentor and develop junior data management staff.
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. 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. Previous people management experience is preferred.