Clinical Trial Manager - Real World Evidence

ICON

Sofia, Bulgaria1w ago

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Key details

Location
Sofia, Bulgaria
Work style
Onsite
Level
Senior
Job type
Full-time
Experience
2–5 yrs
Function
Healthcare
Focus area
other
Posted
1w ago

About the role

Clinical Trial Manager

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.


As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.


Overview

The Clinical Trial Manager (CTM) in ICO RWS is responsible for the operational oversight of all the milestones and activities assigned projects, including site management and monitoring activities. This includes remote site management conducted by the Site Management Associates (SMAs) and onsite monitoring conducted by the Clinical Research Associates (CRAs). CTMs oversee the activities of these assigned CRAs and SMAs including site activation, ongoing site communication, remote and onsite visit planning, document collection and maintenance, regulatory approvals, site close out and documenting all activities within a Clinical Trial Management System (CTMS). The CTM develops site monitoring and management plans, develops and conducts training for the clinical team, reviews trip reports, and proactively identifies risks and mitigation strategies that may impact the delivery of clinical activities. The CTM is responsible for reviewing metrics and dashboards to support their oversight of the clinical operations and may take a lead role in the data review and query management activities. CTMs work closely with the RWS Project Manager, Finance and Data Management to deliver according to the scope, timeline and budget. CTMs are also client/sponsor facing and provide metrics and key study updates to their sponsor counterparts as defined in the project plans.

Locations: Bulgaria, Georgia, Poland or South Africa

Key responsibilities include:

  • Plan and manage all Clinical Operations aspects of clinical trials/studies, ensuring adherence to timelines, budget, and quality standards.

  • Collaborate with global cross-functional teams to establish and implement clinical trial/study protocols and procedures.

  • Build and manage strong relationships with investigators and stakeholders.

  • Ensure all trials/studies are conducted in compliance with local, national, and international regulations and ethical guidelines.

  • Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management.

  • Leading the clinical team to deliver the study in accordance with sponsors expectations.

Your Profile:

You will have solid clinical trial/study management experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

  • University degree in medicine, science, or equivalent combination of education & experience with at least 2 years’ experience in the similar role / in CRO or Pharma company.

  • In depth RWE Clinical Trial Management exposure

  • Demonstrated ability to drive the clinical deliverables of a study

  • Worked across different clinical studies in various therapeutic areas in Phases III and/or IV.

  • Prior experience with risk-based monitoring (RBM) oversight is desirable

  • Willingness to travel as required (approximately 15%)

  • Ability to work on multiple project/clients simultaneously on assigned FTE and demonstrated strong time management skills.

  • Experience is non-interventional studies is a plus but not required.

#LI-JD1

#LI - Remote


Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


Visit our careers site to read more about the benefits ICON offers.


Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply

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