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Company

Alnylam Pharmaceuticals · 7 hours ago

Director, Data Management

United States

Full-time

Remote

Director/Executive

15+ years exp

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BiotechnologyHealth Care

Comp. & Benefits

H1B Sponsor Likely

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Responsibilities

Direct and grow internal data management expertise area, including management of direct reports;

Direct and establish standards for data management CRO outsourcing strategy and deliverables, including the CRO selection process and the governance of CRO performance;

Oversee the successful execution of all data management activities in support of Alnylam clinical studies in partnership with CROs, including eCRF development, database build, data collection, data coding, cleaning, database lock and archiving;

Supervise the execution of cross-functional, internal data review plans by direct reports across all Alnylam clinical studies;

Partner with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Quality Assurance, Clinical Pharmacology and Pharmacometrics, Bioanalytical, Global Patient Safety & Risk Management (GPSRM), Regulatory Affairs, and Medical Affairs; CROs, central and local laboratories, and other vendors;

Lead development and implementation of data collection standards, consistent with industry best practice;

Lead data management contributions to the development of clinical protocols, clinical study reports and other regulatory documents, e.g. DSURs, Briefing Documents, etc.

Oversee development of department workflows, and infrastructure strategy and implementation, such as preferred provider initiatives, SOPs, and templates;

Collaborate with Statistical Programming and external vendors to ensure compliance of SDTM clinical datasets, consistent with CDISC standards;

Collaborate with Clinical Operations and Quality Assurance to certify the integrity and traceability of all clinical data sources, compliant with 21 CFR Part 11 standards;

Direct Data Management GCP inspection readiness efforts; function as a leader for Data Management in GCP inspections;

Represent Data Management at internal cross-functional meetings and external vendor leadership meetings;

Demonstrate clear alignment with Alnylam Core Values including, Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture and Passion for Excellence.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Clinical data managementEClinical processesCDISC standardsLeadership experienceEDC data management systemsRegulatory requirementsGlobal study managementPerformance reviewsMS Office SuiteMedidata Rave EDCMedical terminology

Required

BS/BA in scientific discipline

at least 15 years of clinical data management experience in a pharmaceutical/biologics/biotechnology company

at least 5 years in a leadership capacity

Extensive experience managing global studies utilizing an outsourced CDM model from start-up through close-out

Extensive experience managing direct reports and providing performance reviews and career development guidance

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

Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial data/Data Management Systems

Expert knowledge and understanding of regulations and industry-adopted data standards, such as CDISC-SDTM and CDASH

Experience using standardized medical terminology, including MedDRA and WHODrug

Experience working Medidata Rave EDC systems

Experience working with MS Office Suite (Excel, Word and PowerPoint) familiar with MS Project

Excellent written and oral communication skills

Highly motivated and flexible, with excellent organizational skills

Ability to work independently and as part of a multi-disciplinary team

Preferred

MS or equivalent preferred

Company

Alnylam Pharmaceuticals

Glassdoor

3.8

Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.

Founded in 2002

Cambridge, Massachusetts, USA

1001-5000 employees

http://www.alnylam.com

H1B Sponsorship

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Trends of Total Sponsorships

2022 (9)

2021 (23)

2020 (11)