Global Trial Associate
il y a 3 semaines
**Global Trial Associate (GTA)-Global Clinical Operations Leadership Development Program 2024**
At Johnson & Johnson, we use technology and the power of teamwork to discover new ways to prevent and overcome the world’s the most significant healthcare challenges. Our Corporate, MedTech, and Pharmaceutical teams leverage data, real-world insights, and creative minds to make life-changing healthcare products and medicines. We're disrupting outdated healthcare ecosystems and infusing them with transformative ideas to help people thrive throughout every stage of their lives. With a reach of more than a billion people every day, there’s no limit to the impact you can make here. Are you ready to reimagine healthcare?
Here, your career breakthroughs will change the future of health, in all the best ways. And you’ll change, too. You’ll be inspired, and you’ll inspire people across the world to change how they care for themselves and those they love.
Amplify your impact. Join us
**Company Overview**
At Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and balanced lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it is found. We are Janssen.
Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
**Position Summary**
The GCO Leadership Development Program consists of 12 months of dynamic rotations with in-depth training across the CTA, SM, LTM roles, supported by strong line management, formal mentorship, sponsorship, networking, focused leadership development and dynamic real world work experience.
Global Trial Associates (GTAs) will rapidly gain knowledge, develop technical and leadership skills and important insights into how the business operates.
The objective is for the GTA to develop an understanding of pharmaceutical development, GCO standard operation procedures, policies and regulatory requirements, logístical and administrative tasks related to trial management (start-up, execution and closing phases) and patient safety in clinical trials.
The GTA will gain knowledge of and support activities of the Site Manager (SM) and Local Trial Manager (LTM) positions under the direct supervision of LTM and SM mentors, Program Manager, and/or Functional Manager (FM).
Upon successful completion of the program, GTAs will be placed in either the LTM or SM role depending on business need and skill set of the GTAs.
**Principal Responsibilities:
- Provide administrative and logístical 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.
**Qualifications**:
**Education and Experience Requirements:
- Must be graduating no more than 12 months prior to the target start date of July 2024, with a Bachelor’s or Master’s degree (e.g., BA, BS, MS), in Health Sciences or re
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