Clinical Data Manager - Katalyst Healthcares & Life Sciences

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.

Requirements:

• BS/BA in scientific discipline

• At least 8 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; 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 ICH GCP and general knowledge of industry practices and standards.

• Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11.