Director, Data Management

Position Summary:

We are seeking a Director, Data Management (DM) to oversee the quality of our outsourced Data Management activities for active and planned clinical studies. This person will initially serve as the lead data manager for our ongoing Phase 1 oncology studies as well as creating and leading the strategy for forming and building the internal Data Management infrastructure for Synthekine’s multiple programs and clinical studies. This experienced data manager will direct project teams and external vendors towards efficient strategies and tactics for clinical data collection and integration across multiple platforms. Also, the successful candidate will be comfortable interacting with key stakeholders from a multitude of scientific disciplines. This position will report to VP, Clinical Development Operations and will be located in Menlo Park, CA.

Key Responsibilities:

The Director of DM will be responsible for working in conjunction with the Clinical Team Managers on the following activities:

• Serve as a data management expert and will be the Clinical Data Management lead for assigned clinical studies on multidisciplinary project teams to deliver high quality data for analysis and study milestones. Review and provide input into protocols to ensure the data collection, database and reporting requirements can be met and are standardized across the programs
• Manage and oversee data management related activities with external vendors including data management timelines, EDC/IWRS set up, study database design, clinical data capture, data transfer specification development, data discrepancy management and data reconciliation.
• Develop data visualizations in collaboration with third party resources or CROs
• Develop, review and revise global SOPs providing team training where applicable
• Manage design and development of eCRFs, clinical review, and communication with applicable vendors
• Oversee and manage the development and implementation of edit check specifications and work with programmers and applicable vendors during programming & validation, including overseeing User Acceptance Testing 
• Lead data reviews with clinical team to ensure accuracy, consistency, and reliability of data
• Review and approve key clinical data management deliverables including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, serious adverse event reconciliation plans, medical coding, data listing specifications, and electronic data transfer agreements
• Manage/oversee study setup, testing and system validation for new studies in partnership with the DM vendor
• Collaborate with cross functional team members on identifying critical variables in the clinical dataset, for protocol-specified endpoints. Coordinate implementing these variables into CRO DM activities.
• Lead Data Management related vendor audits as necessary, as well as authoring, review, and revision of SOPs.
• Monitor vendor performance to ensure timelines and data quality standards are met.
• Ensure compliance of clinical data management processes with applicable regulations and guidelines

Qualifications:

• Bachelor’s degree with at least 12 years relevant work experience. Minimum 10 years of clinical data management experience in a biotech, pharmaceutical or CRO environment
• Understanding of clinical development process, CDISC standards and health authority guidelines and regulations; Knowledge of data management, tools and platforms 
• Significant knowledge on different data visualization platforms and how they can best be leveraged to provide efficient and timely data driven decisions
• Demonstrated ability to establish effective business process and relationships with external stakeholders, including implementation process change with selected vendors
• Excellent written and oral communication skills and interpersonal skills; capability to work within a team environment and manage competing priorities in a changing environment 
• Must be willing to work onsite at least three days per week
• Hands-on experience with Electronic Data Capture systems (Medidata Rave required)
• Experience with vendor management required, including vendor budgeting and auditing
• Experience in developing study documents and SOPs
• Working knowledge of CDISC including CDASH, and SDTM as well as data privacy regulations e.g. GDPR
• Successfully manage clinical data management vendors, contractors and service providers for program deliverables 
• Experience in Oncology and/or Immuno-oncology trials preferred
• Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
• Strong analytical and problem-solving skills

The anticipated salary range for the position of Director, Data Management based in our Menlo Park, CA office is $192,000-234,000.  The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc.  Synthekine is a multi-state employer, and this salary range may not reflect positions that work in other states. We comply with all state federal and local laws regarding pay practices.