Job Description
Our client, a fast-growing clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapies now has a newly created role of Clinical Trial Liaison reporting to Head of Clinical Development in Dublin, Ireland. This role will be based in Ireland and mainly cover EU region, hence EU and other international travel is required.
The Clinical Trial Liaison will work with the clinical investigators and site staff to provide education, support enrollment and retention initiatives, identify mitigate and provide solutions to enrollment hurdles, disseminate product/trial information, represent company interests and provide scientific intelligence.
The successful hire will lead Clinical Trial Recruitment, with oversight for vendor activities, managing insourcing and outsourcing partners to required standards, facilitating communication and transparency with vendors and sites and addressing study related issues appropriately and professionally.
The ideal candidate will be an experienced Global Clinical Trial Manager, with depth of experience in enhancing clinical trial execution and enrollment through building deep relationships with study investigators and research staff in their region. Prior experience as CRA is required.
Responsibilities for Clinical Trial Liaison, EU region:
Work with Head of Clinical Operations and internal team to develop study timelines and ensure cross functional adherence
Identify barriers to enrolment and develop solutions, recruitment plans
Contribute to the study level forecast for investigational product and comparators
Manage study budget, timelines, insourcing and outsourcing partners to required standards
Review and provide input for operational sections at a study level/across multiple studies for study related documents including Protocol, Study Plans, CSRs, Safety related documents
Contribute to execution of feasibility process and selection of sites per study plan
Develop with finance site budget template and approve budgets according to parameters
Organize and where appropriate lead investigator, study coordinator, and CRA training meetings
Author Site Evaluation Visit Plans
Coordinate cross-functional review of escalated issues from sites or other departments
Oversee identification, selection, set-up, management, and relationship of vendor
Approve vendor SOW, invoices and manage budget
Ensure timelines and deliverables are communicated appropriately
Monitor and act upon data flow metrics.
Additionally, this hire will also work to build relationships, where appropriate, with patients groups, scientific organizations, and advocacy organizations.
Requirements for Clinical Trial Liaison, EU region:
BSc in Biological Sciences or related field with experience in a clinical operations organization.
8+ years of experience in clinical operations, clinical development and/or life sciences or medically related field is required.
Proven track record of successful project management and direct experience with operations related responsibilities at a biopharmaceutical company.
Experienced in contributing to writing clinical docs including study protocols, investigator’s brochures, study manuals and plans, and CSRs.
Excellent organizational and communication skills to manage projects
Strong interpersonal skills and track record of managerial responsibility highly desirable.
Manage and co-ordinate clinical study design and implementation at a program and functional level according to GCP and company SOPs.
Provide leadership and support for clinical studies within company.
Exhibits high motivation and high energy level, self-starter.
Problem solver, presents and drives solutions
Effective relationship building
Flexible and adaptable to work in a dynamic, busy start-up environment.
Please contact Larry on +353 1 – 2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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