Principal Clinical Data Manager
Principal Clinical Data Manager
Posted on :
25-06-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
25-06-2025
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 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.
- 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.
Employment Type
Full Time
Key Skills
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