Senior Manager, Clinical Trial Operations Lead

3 weeks ago

United Kingdom Regeneron Ireland DAC Full time £12,000
Job Summary

We are seeking a highly experienced Senior Manager, Clinical Trial Operations Lead to join our team at Regeneron Ireland DAC. As a key member of our clinical operations team, you will be responsible for the operational strategic direction and guidance for respective clinical studies.

Key Responsibilities
  • Develop and implement the operational strategic direction and guidance for respective clinical studies.
  • Lead and manage cross-functional study teams responsible for clinical study delivery.
  • Provide operational input into protocol development and oversee the development of study-specific documentation.
  • Ensure compliance with clinical trial registry requirements and identify outsourcing needs of the study.
  • Lead and oversee engagement, contracting, and management of required vendors.
  • Provide input into baseline budget development and management.
  • Lead risk assessment and identifies risk mitigation strategies at the study level.
  • Lead the feasibility assessment to select relevant regions and countries for the study.
  • Oversee/conduct site evaluation and selection.
  • Lead investigator meeting preparation and execution.
  • Monitor progress for site activation and monitoring visits and acts on any deviations from plan.
  • Lead the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan.
  • Monitor data entry and query resolution and acts on any deviations from agreed metrics.
  • Ensure accurate budget management and scope changes for internal and external studies.
  • Oversee and provides input to the study drug and clinical supplies forecasting, drug accountability, and drug reconciliation.
  • Escalate issues related to study conduct, quality, timelines, or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues.
  • Oversee the execution of the clinical study against planned timelines, deliverables, and budget.
  • Oversee data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites.
  • Oversee and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work.
  • Ensure clinical project audit and inspection readiness through the study lifecycle.
  • Support internal audit and external inspection activities and contributes to CAPAs as required.
  • Manage and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability.
  • Contributes to clinical study report writing and review.
  • Facilitates and contributes to study level lessons learned.
  • Assigns tasks to Clinical Study Management staff and supports their deliverables.
  • Recommends and participates in cross-functional and departmental process improvement initiatives.
  • Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs.
  • May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring.
  • Responsible for direct supervision of CTM staff.
Requirements
  • Exceptional interpersonal and leadership skills.
  • Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies.
  • Demonstrates expert knowledge and a data-driven approach to planning, executing, and problem-solving.
  • Advanced communication skills via verbal, written, and presentation abilities.
  • Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization.
  • Ability to influence and negotiate across a wide range of stakeholders.
  • Strong budget management experience.
  • An awareness of relevant industry trends.
  • Ability to build, lead, and develop productive study teams and collaborations.
  • Applies advanced negotiation and interpersonal skills to vendor management.
  • Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC.
  • Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents.
  • Knowledge of ICH/GCP and regulatory guidelines/directives.
  • Advanced project management skills, cross-functional team leadership, and organizational skills.
  • Line management experience.
Education and Experience

In order to be considered qualified for this role, you must possess a Bachelor's degree with a minimum of 8 years of relevant industry experience.

Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents.

You will also need technical proficiency in trial management software and MS applications to be considered.

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