Clinical Project Manager

The Role

As Local Trial Manager you will be responsible for running international/global studies in all therapeutic areas, 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 (COLA) to close out at a country level in accordance with ICH-GCP and other applicable local regulations.

RESPONSIBILITIES OVERVIEW

• 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 (LST)

• Support country-level operational planning and accountable for site selection within assigned country(ies)

• Contribute and develop to program,/study-specific materials – e.g., monitoring plan, study specific training documents.

• Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country(ies)

• 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

• Provide updates regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range)

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

REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s degree in a healthcare or other scientific discipline

• Minimum 2-3 years’ experience of leading local/regional or global teams

• Minimum 2-3 years’ clinical trial project management experience

• Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.).

REQUIRED KNOWLEDGE

• Local 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

• Project and Program management including oversight of study deliverable, budgets and timelines

• Time, cost and quality metrics, Key performance indicators (KPIs)

• Must have fluency in English, Dutch and French languages

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