Description
Primary Responsibilities:- Leads a multi-functional study team responsible for the implementation of a clinical study or clinical program
- Participates in the CRO and vendor selection process
- Manages all aspects of the relationship with CRO(s) and other clinical vendors throughout clinical study lifecycle
- Site management (either directly or through a CRO)
- Prepares/writes clinical protocols and amendments under the guidance of the medical monitor
- Develops template informed consent forms and reviews and approves site specific informed consent forms
- Creates, reviews and refines clinical study management and vendor oversight plans
- Leads study data review for quality and consistency with study objectives
- Oversees submission of study-related documents to the Trial Master File
- Maintains effective relationships with clinical collaborators and clinical site personnel
- Manages study timelines, budgets, and resource allocation; reviews and reconciles financial aspects of study to ensure the study is executed within the timeline and budget
Experience / Skills Required:
- Bachelors degree in a scientific field or equivalent
- 5+ years direct experience managing industry sponsored clinical studies, including field monitoring experience
- Thorough knowledge of ICH/GCP guidelines, FDA requirements for INDs, NDAs, and drug approval process
- Excellent analytical, negotiation, and problem-solving skills
- Outstanding organizational, communication, and presentation skills
- Thorough understanding of clinical study activities including data management, drug safety, biostatistics, and medical writing
- Pro-active and transparent communicator
- Ability to multi-task and communicate at all levels within the organization
To find out more about Real please visit www.realstaffing.com