SummaryThe Director, Clinical Data Management is responsible for the oversight of data management activities in support of Alnylam studies across all stages of clinical drug development. This position reports to the head of the Clinical Data & Insights group.
Responsibilities: - Direct and grow internal data management expertise area, including management of direct reports;
- Direct and establish standards for data management CRO outsourcing strategy and deliverables, including the CRO selection process and the governance of CRO performance;
- Oversee the successful execution of all data management activities in support of Alnylam clinical studies in partnership with CROs, including eCRF development, database build, data collection, data coding, cleaning, database lock and archiving;
- Supervise the execution of cross-functional, internal data review plans by direct reports across all Alnylam clinical studies;
- Partner with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Clinical Pharmacology and Pharmacometrics, Bioanalytical, Safety & Risk Management (SRM) and Regulatory Affairs; CROs, central and local laboratories, and other vendors;
- Lead development and implementation of data collection standards, consistent with industry best practice;
- Lead data management contributions to the development of clinical protocols, clinical study reports and other regulatory documents, e.g. DSURs, Briefing Documents, etc.
- Oversee development of department workflows, and infrastructure strategy and implementation, such as preferred provider initiatives, SOPs, and templates;
- Collaborate with Statistical Programming and external vendors to ensure compliance of SDTM clinical datasets, consistent with CDISC standards;
- Collaborate with Clinical Operations and Quality Assurance to certify the integrity and traceability of all clinical data sources, compliant with 21 CFR Part 11 standards;
- Direct Data Management GCP inspection readiness efforts; function as a leader for Data Management in GCP inspections;
- Represent Data Management at internal cross-functional meetings and external vendor leadership meetings;
- Demonstrate clear alignment with Alnylam Core Values including, Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture and Passion for Excellence.
Requirements- BS/BA in scientific discipline, MS or equivalent preferred, with at least 15 years of clinical data management experience in a pharmaceutical/biologics/biotechnology company, with at least 5 years in a leadership capacity;
- Extensive experience managing global studies utilizing an outsourced CDM model from start-up through close-out;
- Extensive experience managing direct reports and providing performance reviews and career development guidance;
- 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 systems;
- Experience working with elluminate or other data visualization systems a plus
- Experience working with MS Office Suite (Excel, Word and PowerPoint) familiar 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.
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U.S. Pay Range$197,200.00 - $266,800.00The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).
Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers
