Clinical Project Manager Innovative pharma Hungary
Job Summary
This is an opportunity to join a global innovative big pharma in Hungary as Clinical Project Manager. The role is responsible for local management of a clinical trials in the county with operational insight of assigned protocol(s) from start-up through to database lock and close-out activities.
Additional accountabilities of the future Clinical Project Manager include but are not limited to:
Additional accountabilities of the future Clinical Project Manager include but are not limited to:
- Collaboration with fellow Manager roles for country protocol feasibility and site feasibility assessment. Implementation of local criteria for site with other study team members to select final site list.
- Leading and coordinating local trial team activities in compliance with SOPs other procedural documents and applicable regulations.
- Monitoring country progress and initiation of corrective and preventive actions (CAPA) when the trial deviates from plans and communication of study progress and issues to study management teams.
- In certain situations possible assistance in negotiation of trial site contracts and budgets. Management of country trial budget to ensure accurate finance reporting and trial delivery-within budget.
- Scheduling and conducting country investigator meetings.
- A minimum of BA or BS degree of Life Sciences or related scientific field.
- Minimum of 3years of individual clinical monitoring experience.
- At least 2-3years of Lead Clinical Monitoring experience or equivalent is preferred.
- Strong experience in mentoring / coaching and providing training to other Clinical Project Managers Clinical Research Associates and Clinical Trial Assistants.
- Solid understanding of GCP and local regulatory requirements.
- Willingness to travel with occasional overnight stay away from home.
- Strong leadership communication and computer skills.
- Proficiencyin speaking and writing in the country language and English.
Required Experience:
IC