Clinical Research Lead

2 days ago

Dublin, Dublin City, Ireland WEP Clinical Full time

At WEP Clinical, we are seeking a highly experienced Clinical Research Lead to join our team. This key role plays a crucial part in ensuring the success of clinical trials and Expanded Access Programs (EAPs) by providing expert medical guidance and scientific oversight.

About the Role:

  • The Medical Director will serve as the primary medical and scientific expert for clinical trial protocols and EAPs, ensuring the accuracy, integrity, and successful execution of studies.
  • This includes guiding investigators and internal/external teams in implementing and adhering to the study protocol, medical and safety monitoring, data interpretation/presentation, and providing expert input on all medical aspects of the trial.

Your Key Responsibilities:

  • Act as the primary point of contact for all medical-related inquiries from investigators, regulatory agencies, and internal/external teams, providing clarification and ensuring consistent protocol interpretation.
  • Monitor clinical trials and/or EAPs to ensure participant's safety, data accuracy, and compliance with the protocol. Address medical issues as they arise throughout the study and/or program.
  • Participate in discussions with investigators during the site selection phase to assess their experience and suitability for the trial and/or programs.
  • Book and lead conference calls with investigators to discuss inclusion/exclusion criteria and provide personalized attention to ensure optimal site selection and patient recruitment.
  • Serve as the primary medical expert for the clinical trial protocol, ensuring full comprehension and adherence by investigators, study teams, and stakeholders.
  • Review adverse events (AEs), serious adverse events (SAEs), and other safety-related reports to ensure proper documentation and timely reporting.
  • Provide causality assessment of adverse events (AEs), especially those that may request expedited reporting to regulatory authorities.
  • Work with Data Safety Monitoring Boards (DSMBs) and other safety committees to provide safety oversight and evaluate ongoing trial data for participant safety.
  • Provide ongoing training and support to investigators, site staff, and internal/external teams on the protocol and therapeutic area, ensuring thorough understanding and adherence to the medical and scientific objectives of the study.
  • Participate in investigator meetings, site initiation visits, and study-related training to present and explain protocol-related issues, clarify eligibility criteria, and address any medical concerns.
  • Lead protocol, treatment guidelines, and other project documents by providing key medical input on study design, endpoints, inclusion/exclusion criteria, and overall trial/program methodology.
  • Provide oversight to ensure that study conduct aligns with the protocol, identifying, classifying, and resolving any deviations, as well as ensuring the scientific and ethical integrity of the trial.
  • Collaborate closely with clinical operations, regulatory, and project management teams to ensure trials comply with Good Clinical Practice (GCP) and regulatory requirements.
  • Work with pharmacovigilance teams to ensure timely and accurate safety reporting and management of safety signals during the trial.
  • Represent Medical Affairs in marketing and sales efforts by developing project bid proposals, participating in bid defence meetings or performing client presentations, as requested.
  • Provide expert medical guidance in cross-functional meetings, helping to resolve protocol-related challenges and ensuring the scientific objectives of the trial are met.

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