Clinical Trial Manager (Sponsor Dedicated)

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.