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Select Projects is part of the Select group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis. Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro) chemical, Construction and Rail. From our offices in Antwerp and Rotterdam we optimally support our experienced specialists so that they can deliver high quality to our customers at all times.
CLINICAL TRIAL MANAGER
Description de la fonction
For one of our pharmaceutical clients in Beerse, we are currently looking for a motivated Clinical Trial Regulatory Leader:
- You will be responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 - Phase 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).
- You will ensure that the required regulatory intelligence is in place to comply with country specific requirements and will lead a cross-functional team that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.). Furthermore, you will either submit the CTA's directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country.
- You are responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTA's.
- You manage the Output Protection Process for assigned trials and ensure that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system. If Clinical Research Organizations are contracted to handle some (or all) aspects as outlined above, you will be responsible for liaising with and overseeing CRO staff, as required.
- You identify and (proactively) respond to issues, problems or opportunities as it relates to the leading the CTA workgroup.
- You identify the need for and collect information (from CTA working groups, GCO, HA-interactions, Local Operating Companies, Regional offices etc.) to better understand and resolve issues/challenges and seize opportunities.
- You integrate information from a variety of sources, detect trends, associations and cause-effect relationships and communicates to supervisor, CTA working group and others as appropriate.
- You propose relevant options for addressing problems or opportunities to supervisor.
- You make decisions independently for day-to-day activities of CTA workgroup. Decisions as they relate to changing processes that affect external stakeholders require consultation with supervisor and CTA Process Owner.
You have overall relations with:
- Regulatory Affairs staff within the global, regional, and therapeutic area organizations
- Cross-functional CTA working group team members
- Local clinical trials staff
- Health Authorities
- CRO's (if applicable)
As Clinical Trial Manager you possess the following competences:
- You have a Bachelor's or Master's degree required with experience in the pharmaceutical or health sciences industry
- You possess a minimum of 4-6 years' experience within regulatory affairs in the pharmaceutical industry. An understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is also required
- You must have strong communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur
- You have strong project management skills (e.g. planning, prioritization, management of schedules and timelines, detail orientation, strong sense of urgency)
- You are able to lead complex projects and a high degree of problem solving capability required
- You have a high level of self-awareness and adaptability and strong impact and influencing skills
- You have demonstrated the ability to lead multi-functional teams and build strong, productive relationships across the organization
- You are able to work independently, strong initiative
- You can work remotely from supervisor
You get an attractive salary package with interesting fringe benefits. A company car, meal vouchers, group insurance and mobile phone subscription are possible. We ensure that you end up in a pleasant working environment with nice colleagues and opportunities to develop and further develop. Together with you, we map out a training course tailored to your future plans and needs.
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- Type de fonction : Qualité
- Beerse (lieu de travail)
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