Trial Capabilities Associate - French speaking

Competitive
Permanent
Cork
24 Jan 2020
BBBH751730

Exciting new opportunity for a French speaking Clinical Trials Associate to join a Cork based leading global company.

Key Responsibilities include:

Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site's ERB and Competent Authority (CA)(where applicable), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities

Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out

Identify, communicate, and resolve issues

Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems

Leverage previous site / review board engagements to efficiently drive new work

Populate internal systems to ensure accuracy of trial / site performance

Understand and comply with procurements, legal and financial requirements and procedures

Populate Trial Master Files and libraries for future reference

Provide feedback and shared learning for continuous improvement

Leverage trial prioritization

Anticipate and monitor dynamically changing priorities

Basic Qualifications:

Bachelor's degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred

Experience in clinical submission ERB

Experience in guidelines and policies (budget and contract) and Contrat Unique decret

Understanding of the overall clinical development paradigm and the importance of efficient site initiation

Applied knowledge of project management processes and skills

Appreciation of / experience in compliance-driven environment

Effective communication, negotiation, and problem solving skills

Self-management and organizational skills

Language capabilities in the followings (English with French)

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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