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Global Clinical Operations Leader / Clinical Trial Manager

External
Parexel logoParexel · - Raleigh - North Carolina
Full-timeRemoteToday
Clinical TrialsComplianceDocumentationGCPLeadershipStakeholder Management
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About the role

We are seeking a Global Clinical Operations Leader/Clinical Trial Manager to join our team in a remote position. As a Global Clinical Operations Leader/ Clinical Trial Manager, you will lead the clinical operations strategy and execution of global clinical trials. This role has direct accountability for delivering studies on time within budget and to the highest quality standards while ensuring patient safety and regulatory compliance. You will serve as the primary clinical liaison to project leadership and sponsor teams coordinating cross functional contributors across regions and time zones. This is a highly visible leadership role suited for individuals who thrive in complex global environments and are comfortable making decisions in ambiguous situations. Success requires strong ownership, the ability to lead without close supervision and a history of delivering clinical trials within a CRO environment.

Responsibilities

  • Lead global clinical operations strategy and execution for assigned clinical trials.
  • Drive study startup including site selection, monitoring strategy, and operational planning.
  • Coordinate cross functional teams across geographies ensuring alignment on timelines quality and deliverables.
  • Monitor study progress including recruitment retention data quality and timelines and take corrective action when needed.
  • Identify risks early and implement mitigation and contingency plans.
  • Provide leadership direction and performance feedback to project team members.
  • Function as primary point of contact for sponsors on clinical operations topics.
  • Ensure compliance with ICH GCP regulatory requirements and internal processes.
  • Oversee maintenance and quality of study documentation and central files.
  • Support audits inspections and study closeout activities including database lock and archiving.
  • Provide strategic oversight of the integrated data delivery (IDD) framework and champion a proactive data-quality culture
  • You will thrive in this role if you bring:
  • Strong leadership decision making and problem-solving skills
  • Demonstrated ability to lead global teams across cultures and time zones
  • Ability to prioritize competing demands and remain accountable for outcomes
  • A proactive mindset with strong ownership and sense of urgency
  • Excellent communication and stakeholder management skills
  • Comfort working in a fast-paced performance driven environment
  • Required Qualifications
  • Degree in life sciences, nursing, or equivalent clinical research experience
  • Minimum of 5 years of experience leading clinical operations within a CRO environment
  • Proven experience in roles such as Clinical Trial Manager, Clinical Project Manager or Clinical Operations Leader
  • Experience leading complex global or multi-region studies
  • Strong knowledge of ICH GCP regulatory requirements and clinical trial processes
  • Experience coordinating cross functional teams and managing study timelines budgets and quality
  • Proficiency with clinical systems and standard tools such as CTMS, EDC, and eTMF

Requirements

  • Prior monitoring experience or strong site engagement background
  • Experience contributing to process improvements or operational excellence initiatives
  • Familiarity with multiple therapeutic areas or late phase studies with priority given to those with Metabolic, Obesity, MASH, Ophthalmology and Dermatology / Immunology
  • The potential base pay range for this role is competitive and aligned to experience level location and demonstrated expertise. Additional incentives may be available based on performance and role scope.
  • This role is designed for experienced clinical leaders who are ready to take full owner

Benefits

Health insuranceVision insuranceRemote work options

Additional Information

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. About Parexel Parexel is a leading global clinical development partner delivering insights driven clinical and consulting solutions to the life sciences industry. With more than 22,000 employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone anywhere. We work with focus agility and shared purpose moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking experienced leaders who are motivated by accountability ownership and measurable impact.


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