Job Description

As a Local Trial Manager, you will be responsible for local management of a clinical trial in a country or countries, managing the operational aspects of projects to meet contractual requirements. You will act as primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and other applicable local regulations.

RESPONSIBILITIES

Partner with global, local country teams and study team to provide high level country strategy, drive study progress and country level study delivery. Accountable for study deliverables and drives key decisions within set country.

Plan, manage, and maintain oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team.

Support country-level operational planning and accountable for site selection within assigned country.

Contribute and develop to program,/study-specific materials \xe2\x80\x93 e.g., monitoring plan, study specific training documents.

Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country.

Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training.

Oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning.

Contribute to the study-level forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE (enrolment long-range estimates) process.

Monitor the execution of the clinical study against timelines, deliverables, and budget for that country.

Monitor and review country and study trends, review Monitoring Visit Reports.

Identify and facilitate resolution of cross-functional study-specific issues.

Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site contracts and budgets.

Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of investigator site relationships.

REQUIRED EDUCATION AND EXPERIENCE

Bachelor\xe2\x80\x99s degree in a healthcare or other scientific discipline

Minimum 2-3 years\xe2\x80\x99 local /regional trial project management experience

Knowledge / expertise of regulatory environment, study start up process and associated timelines etc.

Clinical trial processes and operations

Extensive knowledge of ICH/GCP regulations and guidelines

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