Note: The job is a remote job and is open to candidates in USA. Alnylam Pharmaceuticals is a pharmaceutical and biotechnology company developing therapies for patients with serious diseases. The Senior Manager, Clinical Data Management will lead program-level data management activities across clinical drug development studies, oversee CRO and database activities, manage direct reports, and support regulatory and inspection-readiness deliverables.
Responsibilities
- 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
Skills
- BS/BA in scientific discipline
- 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 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)
- 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
- MS or equivalent preferred
- Experience with drug development in rare genetic diseases preferred
- NDA/MAA submission experience preferred
Benefits
- Annual short-term incentive award (e.g., bonus or sales incentive)
- Annual long-term incentive award (e.g., equity)
- Medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Lifestyle reimbursement program
- Flexible spending accounts
- Health savings accounts
- 401(k) with a generous company match
- Paid time off
- Wellness days
- Holidays
- Two company-wide recharge breaks
- Generous family resources and leave
Company Overview
Company H1B Sponsorship