Więcej informacji
- Numer referencyjny 7/04/2025
- Lokalizacja W Polsce
- Forma wykonywanej pracy praca hybrydowa
- Wymiar czasu pracy pełny etat
- Wymagany poziom doświadczenia Brak
- Wymagany poziom doświadczenia absolwent studiów magisterskich
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Wymagania
Must be graduating no more than 12 months prior to the target start date of July
2025, with Master's degree (MSc) or doctoral students (PhD). -
Poszukiwane kompetencje
We are seeking talented individuals interested in the field of clinical
research to participate in the Global Clinical Operations Leadership
Development Program (GCOLDP).• Excellent organizational skills with the ability to collaborate and manage multiple
priorities within a matrix environment.
• Strong verbal and written communication and presentation skills; knowledge of
MS Excel is preferred.
• Strong interpersonal, leadership, and negotiation skills.
• Ability to speak the local language of the hiring country.
• Fluency in Polish and English. -
Zakres obowiązków
- Provide administrative and logistical support to Clinical Trial Assistant (CTAs), SM and/or LTM in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence, materials, drug distribution and other relevant tasks as appropriate in adherence to relevant SOPs, policies, and local regulatory requirements.
- Support the local study team in performing site feasibility and/or country feasibility. Collaborates with the Global Project Team, e.g. Clinical Trial Manager (CTM)/Global Trial Lead (GTL), local management/Country Head and other study team members, as required.
- Maintain information in relevant systems, including electronic filing (electronic Trial Master File: eTMF).
- Ensure current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes, as applicable.
- Support CTA, SM and/or LTM in collecting/preparing documents required for study start-up/ submission to Ethics Committee/IRB and/or Health Authorities.
- Support CTA SM and/or LTM in collecting, processing, and archiving study related documents as appropriate. Use appropriate systems to ensure file completeness at designated study milestones.
- May assist team in conducting local investigator meeting or with planning for the investigators participating in an international meeting.
- Maintain and update contact information in relevant systems to ensure appropriate safety updates distribution.
- Comply with all training requirements, company policies & procedures and all applicable laws and regulations. Always act aligned with J&J Credo.
- Ensure inspection readiness at all times.
- May contribute to process improvement.
- Support SM and within a reasonable timeframe be able to take on responsibility in executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/ study close-out according to Standard Operating Procedures, Work Instructions (WIs) and policies.
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Oferowane warunki zatrudnienia
A one-year rotational program consisting of dynamic rotations with comprehensive
training in the roles of Clinical Trial Associate, Site Manager, and Local Trial
Manager, supported by strong line management, formal mentorship, sponsorship,
networking opportunities, focused leadership development, and dynamic real-world
work experience.
• The program provides an unparalleled opportunity to develop an understanding
of pharmaceutical development, regulations, compliance, and patient safety.
• Placement in a Local Trial Manager, Site Manager, or equivalent role upon
successful completion of the rotational program.
• Opportunities to build strong relationships within the global cohort of Global
Trial Associates, as well as exposure to senior leaders within the Global Clinical
Operations organization.We offer a full-time paid job with an intention of hiring
after 1-year rotational development program.
Salary details will be provided upon application.Interested candidates for this position are invited by 30 April 2025
- Liczba poszukiwanych osób 2
