Description
Responsibilities:- Lead the implementation and on-time execution of all clinical trials assigned by complying with international regulations from inception through to reporting and publication
- Assist the Head of Clinical Operations to manage internal/external resources and budgets to deliver the agreed clinical trial plan
- Work closely with the Head of QA on all audit issues and deliverables
- Assist in training CRO CRAs and CTMs, site staff, external healthcare professionals and vendor employees
- Provide sites with specific direction and training to ensure the timely and quality completion of clinical trials
- Write and implement SOPs, ensuring adherence for quality and audit accountability
Skills Requirements:
- Experience as Sr. CRA / CTM and study lead for global oncology clinical trial programs
- Understanding and experience in compliance with regulatory and other guidelines in clinical trial conduct
- Project management skills to ensure on-time, high quality delivery of clinical trials within budget
- A strong communicator (both verbal and written)
- Skill in dealing with external vendors (CROs)
- Expertise in audit report accountability; ability to review audit reports and liaise with site members to resolve on site observations and close out on site company audits
- Experience with co-monitoring and parallel monitoring, ensuring quality of data, and escalating site issues to Head of Clinical Operations
- Proficient in revising and creating Standard Operating Procedures (SOPs)
To find out more about Real please visit www.realstaffing.com