Job description:

Responsibilities-

These may include but are not limited to:

Lead and Manage the assigned Phase1/2/3 Clinical study/studies and makes expert recommendations and/or decisions that assure timelines, deliverables and data quality.
Review EDC design, UAT, study metrics and data quality report
End-to-End CDM expertise
Strong knowledge of Rave EDC
Project Management (Min 5 yrs)
Vendor & Stakeholder Management
Technical proficiency to manage CDM deliverables (startup conduct close-out)
Excellent communication skills
Experience in overseeing CDM deliveries and handling multiple vendors
Improve data quality for the study assigned
Collaborates cross-functionally to resolve clinical data issues and ensure effective communication throughout the drug development process.
Resolves and/or escalates issues encountered at the study level and ensures the performance of the data management function.
Provides effective CRO/vendor oversight to ensure requirements are met and the project plans are executed to meet the development needs.
Leverages data management and related expertise to promote best practices across the drug development lifecycle and enhances collaboration with relevant stakeholders.
Pay attention to details
Only US based candidates

Education and Experience:

Required:

MS/BS in life sciences or related field
8 + years of direct Clinical data management experience and at least 4 years of CRO oversight experiences
Experience with Medidata RAVE and other EDC systems
In depth knowledge of clinical data management in the Biotech, Pharmaceutical or CRO industry.
Detail oriented with excellent communication skills and extensive experiences working in cross-functional setting.
Highly knowledgeable and experienced in CDISC standards, CDASH requirements, and CFR-Part 11 Compliance
Knowledge of GCP, ICH and other regional regulations and compliance

Job Type: Contract

Benefits:

Experience:

Work Location: Remote

Lead Clinical Data Manager

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