Global Trial Manager
For one of the leading pharmaceutical companies in the world Real Life Sciences is currently looking for a Global Trial Manager
Global Trial Manager
12 month contract (extension possible)
40 hours per week (3 days on site, 2 remote)
Leiden, the Netherlands.
The Global Trial Manager is accountable for end-to-end operational management of data generation activities or managed access requests. This includes start-up, execution, close-out, analysis and reporting according to planned timelines and budget, and with high quality standards per company procedures and regulatory requirements. You serve as the single point of end-to-end accountability for assigned programs leading the program teams on a global, regional level or local level, while partnering with the Program Leader, Operations Head and Global -Clinical Trial Assistant to ensure overall program delivery at the global, regional and country level.
- Single point of accountability for end-to-end operational management of the assigned programs;
- Accountable for delivery of assigned programs within agreed budget;
- Keeps track on project progress against planned timelines;
- Maintaining project compliance within all applicable Health Authority (HA) regulations, guidelines, internal SOPs and processes;
- 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 utilized for program management (e.g. CTMS and VTMF) according to expectations (metrics) and archiving retention requirements where applicable;
- Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements;
- Identifying and proactively manages issues in a timely manner;
- Communicates and consults timely and regularly with the AD GTL/GPL;
- Escalates issues to appropriate team members;
- Manages risks and builds proposal for Action Plan(s) with the project team to implement solutions on a project level.
Education and (other) experience 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;
- Specific therapeutic area experience may be required depending on the position;
- Project management skills and proficient communication skills are required;
- Ability to work in a virtual and highly matrixed environment.
- Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures;
- Excellent decision-making and strong financial management skills;
- Flexibility and ability to manage study teams in a virtual environment
- Willingness to travel with occasional overnight stay according to business needs.
Are you looking for a very interesting role within one of the leading pharmaceutical companies currently, with many possibilities, please send your most recent resume to m.rill#realstaffing.com or call 0031 20 522 1588.