The Position

The Associate Director, Data Management, reporting to the Senior Director, Data Management, will play an integral role in the success and growth of the functional area at Verve. In this role, you will be responsible for leading Verve data management activities for assigned studies while operating as a direct contributor in an outsourced model. You will also play a significant departmental role by contributing to SOP and standards development initiatives and can grow as a leader within the team as the organization grows and expands our clinical trial portfolio of work.

Job Responsibilities

• Perform vendor oversight (as Verve DM study lead) to ensure adherence to work agreements & study documents, and to ensure quality and timeliness of deliverables in compliance with GCP, SOP & regulatory requirements, and in accordance with key milestones & study timelines
• Represent the Verve data management function at internal and external cross-functional team meetings to align expectations between internal stakeholders & external vendors and to ensure all Verve team needs are addressed related to data deliverables
• Oversee the design and user acceptance testing of clinical study databases in accordance with the clinical protocol and in alignment with industry best practices & standards (for both initial study builds and mid-study updates)
• Serve as primary reviewer & approver for all key data management documents such as CRF completion guidelines, edit check specifications, SAE reconciliation plans, coding plans, data management plans, and data transfer agreements, ensuring that all external vendors meet the highest quality standards
• Lead, facilitate, and conduct internal DM and cross-functional review of clinical data via the authoring and execution of a data review plan for assigned studies
• Plan, coordinate, and manage tasks, timelines and data flow related to Verve clinical data cuts & database locks in collaboration with cross-functional team members & vendors
• Oversee Biometrics service providers as needed via review of statistical analysis plans, SDTM specifications, validation reports, etc. (from a data management perspective) in support of Verve oversight of statistical analysis deliverables & compliance with CDISC standards
• Hire, manage, and mentor internal staff with additional expected expansion of the department and portfolio of studies
• Support Senior Director, Data Management CRO outsourcing strategy and partnership development, including request for proposal development & selection process, partnership management, key performance indicator & budget oversight, process improvement initiatives, issue escalation, and risk mitigation
• Author and contribute to development & implementation of departmental standards and initiatives, such as SOPs, data collection standards & document templates, file sharing platform administration, and exploration of emerging data collection technologies
• Support GCP inspection readiness and comprehensiveness of Trial Master File contributions for Data Management
• Other duties as assigned

Qualifications

• Bachelor's degree required. Scientific or health care related field preferred
• 9 years of clinical data management experience in a biotech or pharmaceutical company
• Extensive experience providing oversight of outsourced clinical data management vendors on global clinical trials and managing vendor relationships
• Phase I – III clinical development experience
• Phase IV and/or long-term observational study experience preferred
• Experience leading data management process improvement initiatives and/or SOPs and standards development
• Prior managerial experience preferred
• Collaborative team player that has a positive approach and is highly motivated, solutions-oriented, flexible and proactive
• Excellent written and oral communication skills, with strong attention to detail
• Excellent organizational, strategic and critical thinking skills with the ability to effectively lead and collaborate with various business functions in a dynamic environment
• Proficiency with EDC databases such as Medidata RAVE, IBM EDC, etc.
• Experiencing working with other clinical data systems such as data visualization, IRT, etc.
• Knowledge of, and experience with CDISC standards (CDASH, SDTM)
• Knowledge of medical dictionary coding standards, and regulatory requirements & guidelines such as FDA & ICH/GCP regulations as applicable for Data Management, 21 CRF Part 11, etc.
• NDA, BLA, MAA submission experience preferred
• Prior pre-approval and/or GCP inspection experience preferred
• Experience with eTMFs pertaining to CDM documentation