CLINICAL DATA MANAGER at cGxPServe San Francisco, CA

cGxPServe; San Francisco (CA); Sur place; USD 100 000 - 140 000; Plein temps

Résumé du poste

cGxPServe is seeking a Clinical Data Manager in San Francisco, CA to oversee clinical data management activities in support of Alnylam clinical studies. The successful candidate will lead database build activities and monitor data collection and cleaning by vendors. An expertise of at least 8 years in clinical data management and familiarity with regulatory standards is essential.

The role requires strong project management skills, excellent communication abilities, and experience with clinical trial systems. You will collaborate across various functions while ensuring compliance with industry standards.

Qualifications

• At least 8 years of clinical data management experience.
• Experience in drug development through Phase 3 in an outsourced CRO model.
• Knowledge of CDISC, SDTM, and CDASH standards.

Responsabilités

• Lead data management activities for Alnylam clinical studies.
• Monitor data collection and coding by vendors.
• Collaborate with teams including Biostatistics and Clinical Operations.

Connaissances

Clinical data management

Cross-functional collaboration

Regulatory knowledge

Project management

Excellent communication skills

Medidata Rave

Formation

BS/BA in scientific discipline

Outils

MSOffice Suite

MedDRA

WHO Drug

Description du poste

CLINICAL DATA MANAGER job at cGxPServe. San Francisco, CA.

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 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.