Principal Clinical Data Manager

Alnylam Pharmaceuticals•Cambridge, MA

2d•$147,900 - $200,100•Remote

About The Position

The Principal Clinical Data Manager, Data Management will lead and contribute to data management activities in support of Alnylam studies across all stages of clinical drug development. This position reports to the Director, Data Management or Associate Director, Data Management.

Requirements

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
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

Nice To Haves

experience with drug development in rare diseases preferred

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