Associate Director, Clinical Data Management

Role Summary

The Associate Director, Clinical Data Management is responsible for program level oversight of clinical data management activities in support of Alnylam studies via both strategic and hands-on support, management of direct reports, oversight of vendors, and contributions to departmental process and standards development, including Risk-Based Quality Management (RBQM). This position reports to the Director, Clinical Data Management.

Responsibilities

• Operate as program level Data Management lead in support of multiple Alnylam clinical studies in an outsourced model by providing strategic support, coordination, and oversight of key Data Management deliverables and activities such as eCRF development and user acceptance testing, review of CRO data management documentation, data cleaning and coding review (including oversight and execution of internal Data Review Plan), SDTM dataset development, and database lock.
• Manage a team of direct reports, providing oversight of individual study lead work activities along with strategic advice, career development guidance, and mentorship; establish performance goals for each direct report and provide regular performance review feedback; develop and execute onboarding plan for training of new hires.
• Serve as an active member of the Data Management leadership team, supporting growth of the expertise area via ownership of and/or participation in standards and process development initiatives and projects, such as authoring SOPs, work instructions, documentation templates and data collection standards consistent with industry best practices.
• Support Director with aspects of Data Management CRO outsourcing strategy and partnership development, including request for proposal development, selection process, partnership management, key performance indicator and budget oversight, process improvement initiatives and the day-to-day oversight of CRO deliverables.
• Support Director with internal resource planning and other strategic planning initiatives and objectives.
• Collaborate with Statistical Programming and external vendors to ensure compliance of SDTM clinical datasets, consistent with CDISC standards.
• Collaborate with internal stakeholders to certify the integrity and traceability of all clinical data sources, including CRF and non-CRF data, compliant with 21 CFR Part 11 standards and with the appropriate supporting documentation of the data flow.
• Collaborate with Clinical Operations on Risk-Based Quality Management activities, including supporting cross-functional study team and Clinical Risk Manager in protocol risk assessment, risk identification and evaluation, and set-up and maintenance of RBQM system; participate in development and expansion of clinical data risk analyst team.
• Support GCP and pre-approval inspection readiness by functioning as a lead for Data Management for all associated preparatory activities (including strategic planning, documentation assembly and mock inspections); participate in the live GCP and pre-approval inspections as a subject matter expert for Data Management.
• Represent Data Management at internal cross-functional team meetings and external vendor meetings, effectively assessing and communicating risks, requirements, and timeline expectations
• Demonstrate clear alignment with Alnylam Core Values including Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence

Qualifications

• BS/BA with at least 12 years of related industry data management experience in a biotechnology/pharmaceutical company, including at least 3 years in a management role.
• Extensive CRO/vendor management experience in an outsourced data management model.
• Extensive experience managing direct reports and providing performance review feedback and career development guidance.
• Experience leading data management process improvement initiatives and/or standards development.
• Experience leading data management in clinical drug development through Phase 3, managing multiple global studies in an outsourced model from start-up through close-out; experience with rare disease and cardiac therapeutic areas preferred.
• Experience working with Medidata RAVE EDC system.
• Experience using standardized medical terminology, including MedDRA and WHODrug.
• Knowledge of CDISC SDTM data standards and direct experience with the Pinnacle21 validation process.
• NDA, BLA, MAA and/or J-NDA submission experience as a data management lead preferred.
• Direct experience participating in FDA, EMA and/or PMDA pre-approval inspections preferred.
• Expert knowledge of industry regulations and best practices, including ICH GCP and 21 CFR Part 11 requirements and CDASH standards for data collection.
• Excellent written and oral communication skills with extensive experience presenting to senior management.
• Experience working with MS Office Suite (Excel, Word, PowerPoint) and familiarity with MS Project.
• Highly motivated and flexible, with excellent organizational and project management skills.
• Ability to work independently and as part of a multi-disciplinary team.
• Fully vaccinated against COVID-19 as defined by the CDC is required where applicable.