Director, Clinical Data Management

Alnylam Pharmaceuticals•Cambridge, MA

1d•$197,200 - $266,800

About The Position

The 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.

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.

Nice To Haves

Experience working with elluminate or other data visualization systems a plus

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.