Clinical Trial Manager perm job CTM
Posted on Jan 18, 2019 by Hays Specialist Recruitment Limited
Your new company
One of the world's largest research-based biopharmaceutical companies that discovers, develops and commercialises innovative medicines in areas of unmet medical need.
Your new role
A Clinical Trial Manager working within the HIV therapeutic area.
Managing European component of global Phases II-III, IIIb outsourced studies managed by a Clinical Program Manager.
Drafting and coordinating review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports. You will be maintaining study timelines and contributing to development of study budget, and contributing to development of RFPs and participate in selection of CROs/vendors.
Managing CROs/vendors, completing/coordinating review of data listings and preparation of interim/final clinical study reports.
You may be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
Responsibilities also include conducting oversight monitoring visits as required, coordinating and supervising all aspects of a clinical study. You may assist Clinical Operations European Therapeutic Area Leads in their duties.
You'll be contributing to Clinical Operations Europe team activities & initiatives, and working with Clinical Program Managers to manage the European 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.
Interacting with cross-functional teams internally and externally to ensure trial progress, and incorporating study logistics and planning to accomplish study objectives, as well as serving as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
What you'll need to succeed
- HIV/ infectious disease experience is desirable but not essential.
- Must have multinational (preferably EU) clinical trials experience including study management/coordination.
- Monitoring experience highly desirable as site oversight monitoring visits may be required.
- Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
- Must be able to generally understand, interpret, and explain protocol requirements to others.
- Ability to prioritise and exhibit critical thinking.
- Ability to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
- General, functional expertise to support SOP development and implementation.
- Ability to resolve problems using national and international regulations, guidelines, and investigator interaction.
- Excellent teamwork, communication, decision-making and organisational skills are required.
- Willingness to travel
- Competitive salary
- Extensive development
- Annual Bonus
- Possibility to be home-based 1-2 days
- Felxi time
- Dress down Fridays
Please contact Anu Luur for more information about this job.
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