Clinical Lead for Therapeutic Expertise

1 week ago

Merthyr Tydfil, United Kingdom Simbec-Orion Full time

We are seeking a seasoned Clinical Lead to join our team at Simbec-Orion, a full-service Contract Research Organisation (CRO). With a focus on delivering studies from first-in-human through to Phase III, we provide comprehensive portfolio of trials. Our experts leverage wide therapeutic experience and specialist expertise to execute clinical development solutions for small and mid-size drug developers.

About the Role

In this role, you will be responsible for overseeing the design, execution, and delivery of clinical trials in a Clinical Pharmacology Unit. Your primary objective will be to ensure the safety and welfare of trial participants while delivering high-quality studies that meet clients' development needs.

  • Develop and implement study protocols, risk management plans, and training programs to ensure compliance with ICH-GCP, MHRA Phase I accreditation requirements, and The Independent Health Care (Wales) Regulations 2011.
  • Evaluate participant eligibility and obtain written informed consent for inclusion in a specific study, adhering to Investigator Brochure, Protocol, and Informed Consent Document guidelines.
  • Collaborate with volunteers' General Practitioners regarding their participation in a study, providing collaborative care and follow-up support.

You will also act as a Principal Investigator (including First-in-Human) / Sub-Investigator for clinical trials, ensuring data integrity and taking responsibility for trial decisions. Additionally, you will participate in Commercial Development activities, including feasibility assessments, budget reviews, and proposal development.

A successful candidate will possess strong leadership, line management, and teamwork skills, with excellent verbal and written communication abilities. They will have a thorough understanding of MHRA Phase I Accreditation requirements and be proficient in Advanced Life Support.

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