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Global Clinical Operations Leader / Clinical Trial Manager

5+ years
Not Disclosed
10 Feb. 18, 2025
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Global Clinical Operations Leader / Clinical Trial Manager
Location: Canada (Remote)
Additional Locations: Canada
Job ID: R0000021886
Category: Clinical Trials


Company Overview:

Parexel is a leading global provider of integrated solutions to the pharmaceutical, biotechnology, and medical device industries. With more than 40 years of experience in clinical trials, Parexel aims to bring new treatments to patients faster, improving patient outcomes and accelerating the development and commercialization of innovative therapies. As part of our growing team, we are seeking a Global Clinical Operations Leader (COL) / Clinical Trial Manager (CTM) to join us and lead the clinical operations for multiple global clinical trials.


Job Overview:

As a Global Clinical Operations Leader (COL) / Clinical Trial Manager (CTM) at Parexel, you will be responsible for overseeing the clinical operations strategy for global clinical trials, ensuring timelines, quality, and productivity are met. The Global COL/CTM will lead the clinical operations aspects of the project and coordinate functional teams across various geographies. You will serve as the clinical liaison to the Project Leader, facilitating communication between project leadership, sponsors, and other stakeholders to ensure operational excellence in clinical trial execution.


Key Responsibilities:

Clinical Trial Leadership:

  • Lead the clinical operations aspect of global clinical trials, ensuring the project is executed according to the project plan.

  • Coordinate with cross-functional teams (clinical, regulatory, data management) to drive the trial forward in compliance with quality standards, timelines, and budgets.

  • Liaise with project leadership, sponsors, and stakeholders to track and meet deliverables.

  • Serve as Project Leader for smaller projects or those without a designated Project Leader, managing the end-to-end clinical operations.

  • Provide clinical expertise and guidance to the project team to resolve operational issues and ensure smooth study execution.

Team & Stakeholder Management:

  • Lead and manage a global team of clinical professionals, ensuring effective collaboration and communication across teams and regions.

  • Communicate regularly with sponsors and stakeholders to ensure transparency and alignment on project status, challenges, and solutions.

  • Oversee the day-to-day operations of the clinical trial, providing direction and leadership to functional teams involved in the study.

Operational Excellence:

  • Ensure all clinical trial activities are conducted in compliance with Good Clinical Practice (GCP), regulatory requirements, and Parexel’s standard operating procedures (SOPs).

  • Manage clinical trial milestones, monitoring trial performance to ensure that timelines, budgets, and quality standards are met or exceeded.

  • Strive for continuous improvement in processes and methodologies, identifying areas for optimization and driving operational efficiency.

Client Relations:

  • Build and maintain strong relationships with clients, ensuring high client satisfaction and the successful delivery of clinical trial services.

  • Provide regular updates to clients on the progress of clinical trials and address any concerns or queries promptly.


Qualifications:

Education & Experience:

  • Degree in Life Sciences, Nursing, or a related field; or equivalent relevant experience.

  • Minimum of 5 years of experience leading clinical operations in a full-service role within a Contract Research Organization (CRO).

  • Previous experience in clinical trial monitoring or clinical trial coordination is preferred.

  • Proven track record of leading cross-functional teams and managing clinical trials across multiple geographies.

  • Experience working with global teams and understanding the nuances of conducting international clinical trials.

Skills & Competencies:

  • Strong organizational and leadership skills with the ability to manage multiple priorities and deadlines.

  • Excellent interpersonal and communication skills, capable of building relationships with both internal and external stakeholders.

  • Detailed-oriented with proficiency in clinical trial management software and other computer applications.

  • Ability to work independently and make informed decisions while managing complex global projects.


Additional Information:

  • Remote position with the flexibility to work from any location within Canada.

  • Join a dynamic and growing team at Parexel, contributing to the development and success of innovative treatments that impact patients worldwide.