Senior Manager, Clinical Data Management

Summary

Join RQM+, a leading MedTech service provider, as a Senior Manager to provide strategic guidance and support for data management and physical infrastructure. You will contribute to data management activities for Alnylam clinical studies, oversee database activities, and collaborate with internal and external partners. Responsibilities include establishing data review plans, reviewing study documentation, and managing junior data managers. This role requires a BS/BA in a scientific discipline, at least 5 years of related experience, and expert knowledge of eClinical processes. RQM+ offers a rewarding work environment with an industry-leading compensation package and a focus on work-life balance.

Requirements

• BS/BA in scientific discipline, MS or equivalent preferred, with at least 5 years related experience in a medical
• Experience with global studies, utilizing an outsourced CRO model
• Experience in clinical MedTech and drug development through concept to post-approval
• Education or work experience in a health-related field
• Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems
• Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH
• Experience working with multiple EDC platforms
• Experience using standardized medical terminology, including MedDRA and WHODrug
• Experience working with MS Office Suite (Excel, Word, and PowerPoint) and familiarity with MS Project
• Excellent written and oral communication skills
• Highly motivated and flexible, with excellent organizational and time 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 and applicable ISO and CFR regulations

Responsibilities

• Contribute to data management activities in support of Alnylam clinical studies, including eCRF development by leading cross-functional reviews of eCRF content
• Establish database build activities, including review of edit check specifications and performance of user acceptance testing
• Monitor data collection, remote and source data verification (SDV), coding, and cleaning by vendors through tracking of study metrics and targeted data reviews
• Oversee database lock activities and ultimate archiving of study data
• Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Product Safety; CROs, central and local laboratories, and other vendors
• Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews
• Review CRO data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications and other study documentation
• Ability to manage junior data managers within a functional team structure
• Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
• 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
• Support GCP inspection readiness

Preferred Qualifications

MS or equivalent

Benefits

• Industry leading compensation package
• Focus on work life balance