Description
Primary Job Responsibilities:- 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
- Participates in the CRO and vendor selection process; manages all aspects of the relationship with vendors throughout clinical study lifecycle
- Site management; Allocates CRA resources; oversees all site visit activities and reviews CRA site visit reports
- Negotiates site CDAs, budgets and contracts
- Prepares/writes clinical protocols and amendments under the guidance of the medical monitor
- Performs feasibility assessment and contributes to the investigator/site selection process
- Creates, reviews and refines clinical study management and vendor oversight plans
- Oversees submission of study-related documents to the Trial Master File
- Assists in providing cross-functional operational plans and cost estimates
- Position may include up to 20% domestic and/or international travel
Education & Skill Requirements:
- Bachelors degree with 7+ years of clinical experience
- 5+ years direct experience managing industry sponsored clinical studies
- 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
To find out more about Real please visit www.realstaffing.com