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For Companies At a Glance
- Tasks: Lead and oversee clinical programs from development to post-marketing activities.
- Company: Join a leading biopharmaceutical company focused on innovative therapies for rare conditions.
- Benefits: Enjoy a hybrid work model, career growth opportunities, and a collaborative culture.
- Why this job: Be part of a mission-driven team making a real impact on patient outcomes.
- Qualifications: 5+ years in clinical trial management with a background in life sciences or medicine.
- Other info: Work in a fast-paced environment with a focus on excellence and innovation.
The predicted salary is between 43200 - 72000 £ per year.
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!
Clinical program lead employer: EPM Scientific
Contact Detail:
EPM Scientific Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical program lead
✨Tip Number 1
Network with professionals in the biopharmaceutical industry, especially those who have experience in clinical trial management. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends in clinical development.
✨Tip Number 2
Familiarise yourself with the specific therapeutic areas that the company focuses on. Understanding the nuances of rare and underserved conditions will help you demonstrate your passion and commitment during interviews.
✨Tip Number 3
Prepare to discuss your hands-on experience in managing clinical trials. Be ready to share specific examples of how you've led cross-functional teams and navigated challenges in previous roles.
✨Tip Number 4
Showcase your knowledge of ICH/GCP guidelines and EU regulatory requirements in conversations. This will highlight your expertise and reassure the hiring team of your capability to ensure compliance in clinical programs.
We think you need these skills to ace Clinical program lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant clinical trial management experience, especially in the EU. Emphasise your hands-on leadership skills and any specific achievements in managing complex clinical programs.
Craft a Compelling Cover Letter: In your cover letter, express your passion for innovation in biopharmaceuticals. Mention your experience with ICH/GCP guidelines and how you can contribute to the company's mission of improving patient outcomes.
Highlight Cross-Functional Collaboration: Demonstrate your ability to work cross-functionally by providing examples of past collaborations with teams such as Medical Affairs, Regulatory, and Data Management. This will show your capability to lead diverse teams effectively.
Showcase Leadership Experience: Detail your leadership roles in previous positions, particularly in mentoring clinical operations staff or leading project teams. Highlight any specific projects where your leadership made a significant impact on outcomes.
How to prepare for a job interview at EPM Scientific
✨Showcase Your Clinical Trial Experience
Make sure to highlight your hands-on experience with clinical trials, especially in the EU. Be prepared to discuss specific projects you've led or contributed to, focusing on your role in managing complex programmes and ensuring compliance with ICH/GCP guidelines.
✨Demonstrate Leadership Skills
As a Clinical Program Lead, you'll need to exhibit strong leadership qualities. Share examples of how you've mentored teams or led cross-functional collaborations. This will show that you can inspire and guide others while managing multiple stakeholders effectively.
✨Prepare for Questions on Regulatory Knowledge
Expect questions about your understanding of EU regulatory requirements and ICH/GCP standards. Brush up on these topics and be ready to discuss how you've ensured compliance in past roles, as this is crucial for the position.
✨Express Your Passion for Patient Outcomes
Since the role focuses on delivering life-changing therapies, convey your commitment to improving patient outcomes. Share personal anecdotes or motivations that drive your passion for clinical excellence and innovation in the biopharmaceutical field.
