EU Clinical Program Lead

2 months ago

London, United Kingdom EPM Scientific Full time

ABOUT THE COMPANY


A global specialty pharmaceutical group focused on developing and commercializing treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders, as well as healthcare solutions for the general population.


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. This role is in accordance with applicable regulations, ICH/GCP guidelines, and Standard Operating Procedures (SOPs) within one specific assigned program.



DESCRIPTION OF THE ROLE


Based in Surrey, the Clinical Program Lead is expected to:


Clinical Program Delivery

  • Support the Director, Global Clinical Affairs in implementing the vision for Clinical Affairs to 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 alongside other Clinical Program Leads.
  • Maintain an overview of the program status and issues, proactively communicating progress, risks, issues, or changes that may impact quality, timelines, and/or budget to the Director, Global Clinical Affairs; provide 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 are not limited to:

  • Building expertise and staying up-to-date in the scientific aspects of the program, e.g., scientific literature review.
  • Protocol development and implementation of Quality by Design principles.
  • Study monitoring, oversight of data quality and integrity, and ensuring the safety and rights of participants.
  • Data management and 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; maintaining relationships with principal investigators and/or expert physicians; investigators meetings (including site initiation visits/accreditation); supporting Clinical Study Leads/Clinical Project Associates in management and oversight.
  • Service providers: selection, contract development, and budget negotiation and monitoring; supporting Clinical Study Leads/Clinical Project Associates in management and oversight of activities and performance.
  • Records management.
  • Implement and ensure inspection readiness within the program; support GCP audits and inspections.


Clinical Program Enabling Activities

  • Implement activities and initiatives that support program and study delivery and overall portfolio efficiency. This includes process enhancements, modernization 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.
  • Manage direct reports within the Clinical Operations team.
  • Support the Director, Clinical Affairs, in professional development for the Clinical Operations Team.
  • Resource management within the Clinical Program, including delegation of responsibilities to project team members.
  • Assist in the training of relevant staff as needed.


Other Responsibilities

  • Support the development of external communications related to clinical programs and studies.
  • Attend conferences and external events.
  • Attend meetings with National Competent Authorities, where required.
  • Organize and lead regular internal clinical team meetings.
  • Organize and lead internal trainings.


ESSENTIAL REQUIREMENTS FOR THE ROLE

  • Graduate qualifications in Biological Sciences, Nursing, Pharmacy, or Medicine (post-graduate qualifications desirable).
  • Working knowledge of international clinical research regulations and requirements, including ICH/GCP guidelines.
  • Proven experience in the management of clinical trials in the EU.
  • Experience in establishing and managing a clinical trial program in the 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 to a team whose work directly benefits healthcare and strives to improve people’s lives.
  • A hands-on opportunity to gain a high degree of commercial exposure.
  • The chance to work alongside world-leading scientific experts.
  • Work with highly talented and dedicated colleagues in a fast-growing company that combines a focus on cutting-edge science with commercial delivery.

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