FREELANCE: Clinical Trial Management Associate - Inflammation

Recruiter
Umbilical Ltd
Location
Uxbridge
Salary
Daily Rate
Posted
07 Sep 2020
Closes
05 Oct 2020
Sectors
Management
Contract Type
Contract
Hours
Full Time

#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.

Accountable for:

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.

Qualifications:

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

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