What are the responsibilities and job description for the Director, Data Management position at Alnylam?
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, Clinical Research, Quality Assurance, Clinical Pharmacology and Pharmacometrics, Bioanalytical, Global Patient Safety & Risk Management (GPSRM), Regulatory Affairs, and Medical 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 withAlnylam Core Valuesincluding, Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture and Passion for Excellence.
Requirements
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 the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, 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. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.
