Principal Clinical Data Managerv

Responsibilities :

• Lead data management activities as a program-level lead data manager in support of 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 & Risk Management (GPSRM), 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 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 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.

Requirements :

• BS / BA in scientific discipline preferred.
• At least years of clinical data management experience in a pharmaceutical / biologics / biotechnology company.
• Experience working in clinical drug development through Phase in an outsourced CRO model while serving as program level DM lead;

experience with drug development in rare diseases preferred.

• Expert knowledge of clinical 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 WHO Drug.
• 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 CFR Part .
• NDA / MAA experience.
19 days ago