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Senior Clinical Data Manager

Company: Alnylam Pharmaceuticals, Inc.
Location: Cambridge
Posted on: June 10, 2021

Job Description:

Senior Clinical Data Manager

Overview

Alnylam is the world's leading RNA interference (RNAi) company.

Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with two approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.

Headquartered in Cambridge, Mass., Alnylam employs over 1,400 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work five years in a row (2015-2019), a Great Place to Work in the U.K. and Switzerland in 2020 and Science Magazine's #1 Top Employer in 2019. Please visit www.alnylam.com for more information.

The Senior CDM 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 Senior Manager, Data Management.

Summary of Key Responsibilities

  • Contribute to data management activities as a lead study 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 and targeted data reviews
  • Oversight of database lock activities and ultimate archiving of study data
  • Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, 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, and conduct data reviews
  • Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation
  • Contribute to development and implementation of department workflows and infrastructure strategy (such as preferred provider interactions, SOPs, and templates) that reflects data collection standards, consistent with industry best practice and regulation
  • 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 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.
  • Support GCP inspection readiness
  • Demonstrate clear alignment with Alnylam Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence

Qualifications

  • BS/BA in scientific discipline,
  • At least 7 years related experience in a pharmaceutical/biologics/biotechnology company
  • Experience working in clinical drug development through Phase 3 in an outsourced CRO model; experience with drug development in rare genetic diseases preferred
  • 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 Oracle InForm and 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 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
  • NDA/MAA experience

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

Keywords: Alnylam Pharmaceuticals, Inc., Cambridge , Senior Clinical Data Manager, Other , Cambridge, Massachusetts

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