Senior Manager, Clinical Data Management

Job Description: • Manages the assigned study/studies and makes expert recommendations and/or decisions that assure timelines, deliverables and data quality. • 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. • Contributes to team building and best practice to achieve the defined data quality with cost efficiency. • Participates in regulatory audit and/or company initiatives. Requirements: • MS/BS in life sciences or related field • 7 + years of direct data management experience and at least 3 years of CRO oversight experiences • In depth knowledge of clinical data management in the Biotech, Pharmaceutical or CRO industry • Strong project management skills and experiences working with CROs/vendors • Demonstrated organizational and interpersonal skills • Detail oriented with excellent communication skills and extensive experiences working in cross-functional setting • Highly knowledgeable and experienced in CDISC standards, SDTM requirements, and CFR-Part 11 Compliance • Knowledge of GCP, ICH and other regional regulations and compliance • Experiences with clinical data lifecycle from database set-up and maintenance to database lock and archiving • Working knowledge of current technologies in clinical trial data collection systems. Benefits: • Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance • 20 days of PTO • 10 paid holidays • Winter company shutdown Apply tot his job Apply To this Job