Senior Manager/Associate Director, Data Management (12-120) FibroGen
The Senior Manager, Associate Director is responsible for overseeing all Data Management (DM) operational activities ensuring compliance with the corporate timeline and scope of work outsourced to the DM service provider (SP) and coordinating activities from other external vendors that may also provide study data. This includes but is not limited to vendor and technology evaluation, qualification and selection, budget assessment and contract negotiations, training and oversight for all DM services from study start-up through study close-out and final reporting. This position reports to Head of Biometrics.
Participate in vendor and technology (e.g., EDC) evaluation, qualification and selection. Involved in RFP development and contract negotiation, as needed.
Oversee and manage all DM related activities outsourced to DM SP as well as other external data sources (e.g. central and/or specialty labs, IVR vendors, etc.) from study start-up through study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time and within budget.
Participate with the Study Operations Teams (SOTs) for all study activities, and lead all DM functional activities using established FGN templates/processes as applicable (e.g. FGN DM standards include CRFs, Completion Guidelines, edit check specifications, metric/status reports, transfer agreements, DMP template, medical coding conventions, etc.).
Provide operational leadership to the direction, planning, execution, collection and handling of all clinical data to the highest quality standards while ensuring the FibroGen established standards.
Review study data for completeness and general clinical sense. Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations.
Develop and manage the data review plan for each assigned study, including maintenance and tracking of findings from all team members through issue resolution and involving the data vendors as needed.
Responsible for ensuring SOP and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical Data Management Practices internally and with DM vendors via regular process auditing.
Participate in the development of SOPs, working practices, DM standards, policies and Clinical Development process improvement supporting clinical data management activities.
Ensure the receipt and proper filing, security and archiving of study related data, both paper and electronic media, at all times.
Able to cultivate effective and productive working relationships with colleagues, subordinates, vendors and management. Able to use clear judgment to solve problems and to escalate issues with proposed solutions, as necessary.
Assist the Head of Biometrics in reviewing competitive bids related to Data Management vendor and in deciding on awarding projects to competing CROs
Assist the Head of Biometrics in providing standards as pertains to Data Capturing on the Project level
Assist the Head of Biometrics in Assessing the Data Management capabilities for competing CROs
Provide Mentorship to Junior Data Managers
Bachelor?s degree in a relevant scientific discipline or equivalent
Minimum of ten years of relevant clinical experience in the pharmaceutical, biotech and/or CRO industries, or equivalent
Skills present in core data management activities (e.g., Data Management Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries). CCDM Certification a plus
Knowledge and experience with various clinical databases (e.g., Clintrials, Oracle Clinical, SAS) and key technologies (e.g., EDC, Scanning/Imaging, IVRS/IWRS)
Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required
Excellent communication, written and interpersonal skills
Self sufficient and able to work with minimal oversight
Demonstrate leadership skills and the ability to lead teams and motivate team members, as needed
Able to prioritize and handle multiple tasks and studies simultaneously
Able to manage direct staff, as needed. Ability to develop project management objectives and manage performance reviews, as needed
Proficiency with MS Word, Excel, Outlook, and PowerPoint, SAS programming a plus
Must be willing to travel as required
||San Francisco, CA |