Principal Clinical Data Manager

Katalyst CRO; City of Albany (NY); On-site; USD 150,000 - 190,000; Full time

Job summary

Alnylam is seeking a Lead Data Manager to drive data management activities across clinical studies. You will lead database build, review cross-functional eCRF content, and manage vendor performance while ensuring data integrity and regulatory compliance.

You will collaborate with Biostatistics, Clinical Operations, Regulatory Affairs, and external CROs; mentor team members and guide data review processes within a robust eClinical framework.

Qualifications

• BS/BA in scientific discipline or equivalent experience.
• 10+ years of clinical data management experience in pharma/biotech.
• Experience leading DM initiatives in CRO outsourcing models.
• Expert knowledge of CDISC, SDTM, CDASH; oversee SDTM implementation/validation.
• Experience with Medidata Rave and data management systems.
• Regulatory knowledge including 21 CFR Part 11.

Responsibilities

• Lead data management activities at the program level for clinical studies.
• Oversee database build, eCRF content review, edit checks, and UAT.
• Monitor data collection/cleaning by vendors and track study metrics.
• Oversee database lock activities and data archiving.
• Collaborate with Biostatistics, CRA, QA, Reg Affairs, and vendors.
• Develop data review plans, data cuts/transfers and oversee reviews.
• Review CRO DM plans, CRF guidelines, and data transfer specs.
• Coordinate SDTM validation with Statistical Programming and CRO.
• Lead DM workflows and infrastructure strategy; create SOPs and templates.
• Represent DM in cross-functional meetings and vendor interactions.
• Mentor/train colleagues; participate in vendor/site staff training.

Skills

Lead data management

Data governance

CDISC SDTM

CDASH

ICH GCP

Regulatory compliance

Vendor management

SDTM validation

Medidata Rave

E DC systems design/build

Excellent communication

Project leadership

Mentoring

MS Office Proficiency

Education

BS/BA in scientific discipline

Tools

Medidata Rave

MS Project

MS Office Suite

Job description

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 on SDTM validation efforts, performing supplemental review of validation reports, SDTM Reviewer Guides and define.xml files as required, 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 as needed.
• Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met.
• Serve as DM reviewer of 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, Fiercely Innovative, Purposeful Urgency, Open Culture and Passion for Excellence.

Requirements

• BS/BA in scientific discipline or equivalent amount of combined educational and work experience is required. Exceptional candidates may be considered with less years depending on experience and education.
• 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; experience with drug development in rare diseases preferred.
• 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.
• NDA/MAA experience.
• 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.