Clinical Operations Manager

1 month ago


Uxbridge, United Kingdom Pharmiweb Full time

Job Description


We are seeking a highly skilled and experienced Clinical Operations Manager to join our team at Pharmiweb. As a key member of our clinical operations team, you will be responsible for leading the execution of large and complex clinical trials from study design through close out.


This role is ideal for individuals with a strong background in global clinical trial operations, including experience developing protocols and key study documents. You will have advanced expertise in implementing operational strategic direction and guidance for respective clinical studies, as well as exceptional interpersonal and leadership skills.


The successful candidate will have extensive experience in managing global clinical trials, including knowledge of ICH/GCP and regulatory guidelines/directives. Additionally, they will possess advanced project management skills, cross-functional team leadership, and organizational skills.


In this role, you will lead cross-functional study teams, oversee study timelines, budget, and ensure compliance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. You will also contribute to ongoing process improvement initiatives and drive innovation in clinical study execution.


Responsibilities:



  • Lead cross-functional study teams responsible for clinical study delivery and serve as primary point of contact for leadership and oversight (as required) for assigned studies.
  • Provide operational input into protocol development and oversee the development of study-specific documentation, including case report forms (CRF), data management plan, monitoring plan, and more.
  • Oversee set-up and maintenance of study systems, including Clinical Trial Management System (CTMS) and Trial Master File (TMF).
  • Ensure compliance with clinical trial registry requirements and identify outsourcing needs of the study, leading and overseeing engagement, contracting, and management of required vendors.
  • Manage budgets and timelines, including risk assessment and mitigation strategies at the study level.
  • Leads feasibility assessments, site evaluations, investigator meetings, and monitors progress for site activation and monitoring visits.
  • Develops and oversees implementation of patient recruitment and retention strategies, ensuring accurate budget management and scope changes for internal and external studies.
  • Ensures data quality, regular review of data metrics, and listings, and oversees the execution of clinical studies against planned timelines, deliverables, and budget.
  • Manages and oversees study close-out activities, including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability.
  • Contributes to clinical study report writing and review, facilitates lessons learned, and assigns tasks to Clinical Study Management staff.
  • Maintains technical proficiency in trial management software and MS applications, driving innovation and process improvement initiatives.

Requirements:



  • Bachelor's degree with a minimum of 8 years of relevant industry experience or advanced degrees considered in lieu of experience.
  • Direct experience managing global clinical trial operations, including experience developing protocols and key study documents.
  • Advanced expertise in implementing operational strategic direction and guidance for respective clinical studies.
  • Exceptional interpersonal and leadership skills, advanced project management skills, and cross-functional team leadership.
  • Technical proficiency in trial management software and MS applications.

Salary Range:


$120,000 - $150,000 per annum, depending on qualifications and experience.


Location:


This role may require up to 25% travel, but most work can be done remotely. The ideal location is flexible, with opportunities to work from anywhere in the world.



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