BE - R and D - Global Trial Manager - Senior
A globally renowned pharmaceutical company is seeking to recruit a R&D- Global Trial Manager - Senior to their office in Belgium. The organisation works across a range of industries, from medical devices to pharmaceutical and consumer goods, and operates in over 60 countries. This position offers an exciting opportunity to work with a prestigious and historic pharmaceutical establishment and provide real regulatory expertise.
- Acting as the single point of accountability for end-to-end operational management of the assigned programs.
- Overseeing the delivery of assigned programs within agreed budget.
- Ensuring accurate program budget management and reconciliation of assigned projects for both Out of Pocket (OOP) costs and FTE costs.
- Responsible for overall contract management, including reviewing & approving of external service provider (ESP) contracts, changing orders, and ensuring services are delivered per contract. This includes forecasting and pro-actively managing program specific budgets
- Tracking project progress against planned timelines.
- Monitoring patient enrolment at global and or regional level and ensuring timely and accurate documentation and communication of project progress.
- Initiating corrections to impacted operations.
- Providing regular status updates to the project team, project owners and Clinical Team / Medical Affairs members.
- Ensuring required reports are generated and available for real time tracking of project status.
- Maintaining project compliance within all applicable Health Authority (HA) regulations, guidelines, internal SOPs, and processes.
- Ensuring quality oversight of assigned projects utilizing the available tools so that the project is in a constant state of inspection-readiness.
- Participating in preparation for, and conduct of, HA inspections and internal Quality Assurance (QA) audits.
- Ensuring correct and timely reporting AEs/SAEs/PQCs, as appropriate.
- Ensuring Inspection readiness by maintaining complete, accurate, and timely data and essential documents in systems utilised for program management (e.g. CTMS and VTMF) according to expectations (metrics) and archiving retention requirements where applicable.
- Complying with relevant training requirements.
- Identifying and proactively managing issues in a timely manner.
- Regularly communicating and consulting with the AD GTL/GPL.
- Escalating issues to appropriate team members.
- Managing risks and building proposals for Action Plan(s) with the project team to implement solutions on a project level.
- Contributing to or leading (cross-) functional process initiatives.
Skills and Requirements:
- Bachelor's degree or equivalent required, preferably in Life Sciences.
- Minimum of 8 years of clinical research experience in the pharmaceutical industry or CRO; other relevant experiences and skills may be considered.
- Specific therapeutic area experience may be required depending on the position.
- Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols, and associated protocol specific procedures.
- Strong IT skills in appropriate software and company systems.
- Willingness to travel with occasional overnight stay according to business needs.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Emily Oakley-Keenan at +44 203 078 9576 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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