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Clinical Trial Manager (Sponsor Dedicated)

Durham, United States of America | 全职岗位 | 居家模式 | R1575313

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Local Trial Manager (LTM)

Global Clinical Operations

Overview

The Local Trial Manager (LTM) provides local management of clinical trials within assigned countries, ensuring studies are conducted in accordance with protocol requirements, applicable regulations, ICH-GCP guidelines, and internal procedures. The LTM is responsible for overseeing operational study delivery from startup through closeout while partnering with cross-functional stakeholders to ensure quality, timelines, and patient recruitment objectives are achieved.

Key Responsibilities
  • Lead country-level execution of assigned clinical trials, ensuring milestones, quality metrics, and timelines are met.
  • Serve as the primary point of contact for country-specific study operations.
  • Support site identification, feasibility assessments, site selection, and activation activities.
  • Collaborate with investigators, site staff, and cross-functional teams to drive study performance and enrollment.
  • Monitor study progress and proactively identify and mitigate operational risks.
  • Ensure compliance with applicable regulatory requirements, GCP guidelines, study protocols, and SOPs.
  • Oversee site readiness, site performance, and issue resolution throughout the study lifecycle.
  • Partner with study teams to develop and execute recruitment and retention strategies.
  • Facilitate study team meetings and communicate study updates, risks, and mitigation plans.
  • Support management of vendors, study supplies, budgets, and invoicing activities as applicable.
  • Coordinate local regulatory submissions and approvals in partnership with study startup teams.
  • Ensure timely and accurate maintenance of study documentation, CTMS, and eTMF records.
  • Support audit and inspection readiness activities and help address findings through corrective actions.
  • Ensure appropriate reporting and documentation of safety-related information and protocol deviations.
  • Contribute to process improvement initiatives and best practice sharing across the organization.
Qualifications
  • Bachelor's degree in Life Sciences, Healthcare, Nursing, Pharmacy, or a related field preferred.
  • Clinical research experience with demonstrated experience managing clinical trial activities.
  • Strong knowledge of ICH-GCP, clinical trial regulations, and study conduct requirements.
  • Experience working with investigators, clinical sites, and cross-functional study teams.
  • Excellent organizational, communication, and stakeholder management skills.
  • Ability to manage multiple priorities in a fast-paced, matrixed environment.
  • Experience with CTMS, eTMF, and other clinical trial management systems preferred.
  • Proficiency with Microsoft Office applications.
  • Ability to travel as required.
Preferred Experience
  • Experience overseeing studies from startup through closeout.
  • Experience supporting global or multicountry clinical trials.
  • Strong problem-solving skills with the ability to proactively identify and address study risks.
  • Demonstrated ability to build effective relationships with internal and external stakeholders.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.