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Kelly Scientific Resources is a specialty service of Kelly Services . As the world's largest provider of HR solutions to the scientific community, Kelly Scientific Resources is focused exclusively on placing skilled scientific professionals in contract, contract-to-hire, and full-time science jobs across a full spectrum of related industries and disciplines. Our scientists contribute to the research and development of therapeutics that change the lives of those affected with disease. We have an exciting contract opportunity in San Francisco for a Manager, Clinical Data Management to join a leading biotherapeutics client. Manager, Clinical Data ManagementDuties: The Manager, Clinical Data Management leads the data management components of a clinical trial ranging from small early phase to large global and late phase programs. The Manager, Clinical Data Management is responsible for ensuring study launch, conduct, and closeout are performed according to company quality standards, Standard Operating Procedures SOPs, Good Clinical Practices GCPs, and International Conference on Harmonization ICH guidelines to fulfill all federal and local regulations. The assigned clinical trials may be high complexity or high risk. Duties include serving as the primary data management liaison with vendors and senior management. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by senior data management when needed. Skills: 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. 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. 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. Manages 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. 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. Provide input to the data management study budget and responsible for managing assigned vendor budgets. 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.
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Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
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