Note: The job is a remote job and is open to candidates in USA. Alnylam Pharmaceuticals is a biopharmaceutical company developing RNAi therapeutics for rare and common diseases. The Principal Clinical Data Manager will lead program-level data management activities across clinical drug development studies, including database builds, data review and cleaning, database locks, SDTM validation, vendor oversight, and inspection readiness.
Responsibilities
- Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies
- Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing
- Monitor data collection, coding, and cleaning by vendors through tracking of study metrics, internal data reviews and vendor key performance indicators
- Oversight of database lock activities and ultimate archiving of study data
- Collaborate 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 and local laboratories, and other vendors
- Establish cross-functional, internal data review plans, coordinate data cuts/transfers, conduct data reviews and oversee data review of team members
- Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation
- Collaborate with Statistical Programming to oversee SDTM validation efforts, performing review of validation reports, SDTM Reviewer Guides and define.xml files, and coordinating feedback to CRO while driving internal decision-making and overseeing issues to resolution
- Lead development and implementation of departmental workflows and infrastructure strategy & development (such as SOPs, work instructions and templates), reflecting industry best practices, standards and regulations
- Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
- Mentor and train internal colleagues on data management activities and tasks as needed, fostering a collaborative environment of learning, growth and development
- Participate in the training of external vendors and site staff
- Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met
- Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc
- Function as a leader for GCP inspection readiness activities for Data Management and serve as a primary point-of-contact for DM during inspections
- 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 of clinical data management experience in a pharmaceutical/biologics/biotechnology company
- Experience working in clinical drug development through Phase 3 in an outsourced CRO model while serving as program level DM lead; experience with drug development in rare diseases preferred
- Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems
- Experience leading initiatives/projects for SOP, process and standards development within clinical data management
- Expert knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH, with experience in overseeing study level SDTM implementation and validation
- Experience working with Medidata Rave
- Experience using standardized medical terminology, including MedDRA and WHODrug
- Experience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS Project
- Excellent written and oral communications skills
- Highly motivated and flexible, with excellent organizational, time and project management skills
- Ability to work independently and as part of a multi-disciplinary team
- 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
- NDA/MAA experience
- Experience with drug development in rare diseases preferred
Benefits
- This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive)
- This role is eligible for an annual long-term incentive award (e.g., equity)
- Medical, dental, and vision coverage
- Life and disability insurance
- A lifestyle reimbursement program
- Flexible spending and health savings accounts
- A 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