Clinical program lead
We're currently partnering with a leading international pharmaceutical company to recruit a Clinical Program Lead.
ABOUT THE ROLE
The Clinical Program Lead is responsible for activities including design, monitoring, data interpretation and
reporting related to the conduct of interventional and/ or non-interventional clinical studies, in accordance
with applicable regulations, ICH/GCP regulations and Standard Operating Procedures (SOPs) within one
specific assigned program.
Clinical Program delivery
* Support the Director, Global Clinical Affairs in the implementation of the vision for Clinical Affairs that drive the quality, cost, speed and efficiency of clinical studies delivery.
* Implement the program strategy and contribute to the overall strategy of the Clinical Affairs department along with other Clinical Program Leads.
* Maintain an overview the program status and issues and proactively communicates to the Director, Global Clinical Affairs progress, risks, issues or changes that may impact quality, timelines and/or budget; provides clinical program level updates as requested.
* Engage cross functionally to ensure transparency, transfer of knowledge and alignment within the program.
* Areas of focus for execution and oversight include, but not limited to:
* Building expertise and keeping up to date in the scientific aspects of the program e.g. scientific literature
* Protocol development, implementation of Quality by Design principles o Study Monitoring, oversight of data quality and integrity, and safety and rights of participants o Data management, data cleaning activities according to timelines Reporting, analysis review and Clinical Study Report development
* Clinical sites: selection, contract development, budget negotiation and monitoring, recruitment, regulatory and ethics submissions requirements, maintain relationships with principal investigators and/ or expert physicians, investigators meetings (including site initiation visits/ accreditation), support Clinical Study Leads/ Clinical Project Associates in management and oversight.
* Service providers: selection, contract development and budget negotiation and monitoring, support Clinical Study Leads/ Clinical Project Associates in management and oversight of activities and performance.
* Records management
- Implement and ensure inspection readiness within the program; and supports GCP audits and inspections.
Clinical Program enabling activities
* Implement activities and initiatives that support the program and study(ies) delivery and overall portfolio efficiency. This includes, but not limited to, processes enhancement, modernisation of clinical trials (i.e. digital integration) and transfer of knowledge. People Management:
* Provide leadership, support, feedback, coaching and mentoring to the core Study Management Team.
* Direct reports within the Clinical Operations team.
* Support the Director Clinical Affairs with professional development for Clinical Operations Team.
* Resource management within the Clinical Program i.e. delegate, as appropriate, to assign responsibilities to project team members.
* Assist in the training of relevant staff as needed. Other
* Support development of external communications related to clinical program and studies.
* Attend conferences and external events.
* Attend meetings with National Competent Authorities, where required.
* Organise and lead regular internal clinical team meetings.
* Organise and lead internal trainings.
QUALIFICATIONS/EXPERIENCE
* Graduate qualifications in Biological Sciences, Nursing, Pharmacy or Medicine (post-graduate qualifications desirable)
* Working knowledge of international clinical research regulations and requirements ICH/GCP guidelines
* Proven experience in management of clinical trials in EU
* Established and managed a clinical trial program in EU
* Working knowledge of data management
* Excellent communication skills, both written and verbal
* Project management skills
* Independence and the ability to lead a team effectively
* Observational and analytical skills
* Good time management and the ability to work to tight deadlines
* Ability to problem solve and make decisions quickly
WHAT'S ON OFFER
* A competitive salary with benefits.
* The chance to contribute and be part of team whose work directly benefits healthcare and strives to improve people's lives.
* A real hands-on opportunity to gain a high degree of commercial exposure.
* The chance to work alongside world-leading scientific experts.
* Working with highly-talented and dedicated colleagues in a fast-growing company that combines
Interested in making a differnece?
Apply now or reach out to learn more about this exciting opportunity!
FAQs
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