Principal CRA

The role is an in-house role based at a growing Pharma company in the London area. Roughly 20% travel is required.
* Manages European component of global Phase 2-3 studies managed by a US based Clinical Program Manager
* Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports
* Maintains study timelines
* Contributes to development of study budget
* Contributes to the development of RFPs and participate in selection and management of CROs and vendors
* Coordinates review of data listings and preparation of interim/final clinical study reports
* May contribute to the development of abstracts, presentations, and manuscripts
* Ensure effectiveness of site budget/contract process
* May be responsible for training CROs, vendors, investigators, and study coordinators on study requirements
* Conducts monitoring/co-monitoring as required
* Assists in determining the activities to support a project's priorities within functional area
* Coordinates and supervises all aspects of clinical study
* Under supervision, may design scientific communications within the company
* Assists Clinical Operations International Therapeutic Area Leads in their duties
* Contributes to Clinical Ops International team activities and initiatives
* May serve as a resource for others within the company for clinical trials management expertise
* Under general supervision, is able to examine functional issues from an organisational perspective
* Works with Clinical Program Managers to manage the EMEA component of global clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes
* Interacts with cross functional teams internally and externally to ensure trial progress
* Will incorporate study logistics and planning to accomplish study objectives
* Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems

Qualifications:
* 4+ years of experience and a BSc or Nursing qualification in a relevant scientific discipline
* Must have multinational (preferably EU) clinical trials experience including study management and coordination
* Must have monitoring experience as site monitoring
* Thorough knowledge and understanding of EMEA Regulations, ICH Guidelines, and GCPs

Interested candidates may send CVs or contact Andrew directly to discuss further details.

Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice.