Description
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.