[Hiring] Senior Manager, Clinical Data Management @Alnylam Pharmaceuticals

Role Description

The Senior Manager, Clinical Data Management will lead and contribute to data management activities in support of Alnylam studies across all stages of clinical drug development.

• Function as program level data management lead in support of Alnylam clinical studies, operating both as an individual contributor and manager of direct reports.
• Lead oversight of database build activities, including cross-functional review of eCRF content, review of edit check specifications, and performance of user acceptance testing.
• Monitor data collection, cleaning and coding by CROs via the execution of internal data review plans and review of all vendor data management documentation; provide oversight of all study database lock activities.
• Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met.
• Provide strategic guidance to direct reports and internal cross-functional team members regarding data management activities in support of database locks, regulatory submissions and/or other key study deliverables.
• Train, mentor and oversee work activities of direct reports; provide regular performance review assessments.
• Author and contribute to development and implementation of departmental standards and infrastructure strategy, such as SOPs, data collection standards and document templates, consistent with industry best practices.
• Support GCP inspection readiness and participate as subject matter expert in GCP inspections.
• Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors.
• Collaborate effectively with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Quality Assurance, Global Patient Safety and Risk Management and Regulatory Affairs; CROs, central laboratories, and other vendors.
• Review clinical protocols/amendments, clinical study reports, etc.
• 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 in scientific discipline, MS or equivalent preferred.
• At least 10 years related experience in a pharmaceutical/biologics/biotechnology company.
• Extensive experience managing global studies through Phase 3 in an outsourced CRO model from start-up through close-out; experience with drug development in rare genetic diseases preferred.
• Experience managing direct reports and providing performance reviews and career development guidance.
• Experience developing Data Management SOPs and standards.
• Understanding of ICH GCP as well as general knowledge of industry practices and standards.
• Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11.
• Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial data/Data Management Systems.
• Expert knowledge and understanding of regulations and industry-adopted data standards, such as CDISC-SDTM and CDASH.
• Experience using standardized medical terminology, including MedDRA and WHODrug.
• Experience working with Medidata Rave EDC system.
• Experience working with MS Office Suite (Excel, Word and PowerPoint), familiarity with MS Project.
• Excellent written and oral communication skills.
• Highly motivated and flexible, with excellent organizational skills.
• Ability to work independently and as part of a multi-disciplinary team.
• NDA/MAA submission experience preferred.

Benefits

• Comprehensive benefits including medical, dental, and vision coverage.
• Life and disability insurance.
• Lifestyle reimbursement program.
• Flexible spending and health savings accounts.
• 401(k) with a generous company match.
• Paid time off, wellness days, holidays, and two company-wide recharge breaks.
• Generous family resources and leave.

Company Description

Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.