Senior Director/Director, Data Management (14-151) FibroGen
The Senior Director/Director, Data Management (DM), Biometrics is responsible for managing, leading and overseeing DM operational activities by ensuring compliance with the corporate timelines and scope of work .
The candidate will be accountable for hands-on management of trials and resources while maintaining a high level of data quality by adhering to corporate, industry and regulatory agency standards. Additionally the candidate will supervise, manage, and lead the design, implementation and ongoing practices of clinical DM processes with internal study resource and/or vendors.
This role is responsible for setting the electronic data capture (EDC) strategy and implementation for the Biometrics Department. 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 role is also responsible for managing and tracking work orders associated with clinical DM activities to ensure that the operating costs for the DM department are achieved within budget.
This position reports to the Head of Biometrics.
Formulates short-term and long-term strategies to improve DM efficiencies, locally and globally.
Creates and maintains positive, cohesive local work environments to maximize harmonization across all functional areas within the Biometrics department and across the Company.
Responsible for the global standardization of DM processes and process improvement and efficiency
Establishes global DM competency models and assists with the development of training programs and ensures staff achievement of position competencies
Directs the activities of DM team members to complete project deliverables on schedule and according to quality standards, and requirements from study start-up through archival
Supports the Head of Biometrics to establish global harmonization among FibroGen and its clinical development partners.
Supports project teams on achieving delivery of quality data, on-time and on-budget
Participates in vendor and technology (e.g., EDC) evaluation, qualification and selection. Supports RFP development and contract negotiation, as needed. Identifies and implements solutions to global DM and EDC issues and concerns.
Assists the Head of Biometrics in reviewing competitive bids related to DM vendors and in deciding on awarding projects to competing CROs
Assists the Head of Biometrics in providing standards as pertains to Data Capturing on the Project level
Oversees and manage DM personnel and related activities outsourced to DM SPs 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.
Assesses the overall quality of data and identifies 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.
Ensures projects are conducted in compliance with operating procedures and good clinical practices. Ensures DM project documentation is in an audit-ready state.
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.
Communicates and escalates project level issues including processes, timelines, resourcing, performance, etc. and establish appropriate course of action with Senior Management.
Reviews literature and research technologies/procedures for improving global DM and EDC practices
Develops global, harmonized SOPs and specific quality processes and procedures for Data Management.
Responsible for ensuring SOP and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical DM Practices internally and with DM vendors via regular process auditing.
Provides Mentorship to DM Staff and aids in staff development, career development, and achievement of competency standards
Assists in preparation and support of clinical documentation for IND and NDA submissions as appropriate
Master?s degree in a relevant scientific discipline or equivalent
Minimum of 15 years of relevant clinical experience in the pharmaceutical, biotech and/or CRO industries, with at least 7 years of supervisory experience managing DM function and personnel.
Strong managerial and interpersonal skills
Extensive experience in core DM activities (e.g., DM 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 and key technologies (e.g., EDC, Scanning/Imaging, IVRS/IWRS)
Experience using clinical DM systems and/or EDC products (e.g. RAVE, Inform, Oracle Clinical/RDC, etc.)
In-depth Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required
In depth knowledge of the clinical trial process, electronic data capture systems, database programming, clinical operations, Biometrics, quality management, and systems applications to support operations
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
Extensive experience in managing and leading DM Staff. 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 |