Director, Data Management

Summary

The Director, 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 Data Management 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, Global Patient Safety & Risk Management (GPSRM) 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 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.

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.