Clinical Trials Data Manager
Location: Amherst, NY
Clinical Trials Data Manager for a non-profit cancer prevention clinical trials research network, to work with data management and study teams, biostatisticians, programmers, clinical research site investigators and personnel, medical personnel, and clinical trial sponsors.
Primary areas of responsibility:
- Communicate with sites regarding clinical trial start-up, conduct and close-out activities
- Support site personnel via email and phone
- Provide training and instruction to sites
- Collaborate with internal teams (e.g., programming, documentation/education, data management) to facilitate and integrate data management processes
- Review, reconcile and validate clinical trial data (e.g., baseline status, treatment, adverse events, follow-up), including discrepancy checking and querying
- Develop, review and acknowledge understanding of data management documentation (e.g., clinical trial protocols, SOPs, instruction manuals)
- Design and review electronic case report forms
- Develop specifications for quality control, metrics and site performance reports
- Participate in procedure development with internal teams, sites, and sponsor
- Train and mentor internal staff and interns as needed
- Bachelor's Degree, preferably in a related field
- Familiarity with medical concepts and terminology
- Strong working knowledge of MS Office Suite (including experience with Excel) and excellent overall technical skills
- Documentation experience (e.g., procedure/instruction development)
- Excellent communication and interpersonal skills, which includes the ability to work with people from diverse backgrounds, build effective relationships with site staff, and interact with colleagues
- Detail-oriented, resourceful, positive and professional demeanor
- Excellent organizational and problem-solving skills
- Ability to work independently and as a team player, multi-task, adapt to changing priorities, perform job duties with minimal guidance, and meet deadlines
- On-the-job learning required
Highly desirable but not required:
- Prior clinical trials management experience
- Experience with clinical trial management systems (Medidata Rave preferred)
- Knowledge of clinical trial guidelines and regulations
- Experience in biology, public health, or other health-related discipline
This position will be based out of the Amherst, NY office, but consideration will be made for a full time remote worker.
Applications will be received through the ADP Workforce Now Career Center using the following link: ADP Workforce Now Frontier Science Career Center.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, age, or veteran status.