FREELANCE: Clinical Trial Management Associate - Inflammation
#11132 - West London - 12 month+
James Carrera at Umbilical Life is engaged with a Pharmaceutical client to source an experienced Clinical Trial Management Associate with strong CRA / monitoring experience to work on Phase I-IIII Trials, specifically within Inflammation; site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
Working closely with Global Trial Managers, you will;
- Assist with set-up of central labs and study vendors as required, including liaising with study management CRO to ensure site training and timely initiation.
- Performs accompanied visits with CRO CRAs to ensure correct study procedures
- Review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
- May assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts, clinical study reports and compilation of investigator brochures under close supervision.
- Vendor Management.
Educated to degree level in a relevant scientific discipline or RN qualification, with;
- Minimum 3 years relevant clinical trial experience in the pharmaceutical or health care industry or equivalent
- CRA, monitoring or Study Management experience highly desirable
- HIV experience preferred but not essential.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
- Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision as required.
- Must be able to prioritise multiple tasks, plan proactively and accomplish goals using well defined instructions and procedures...... click apply for full job details