DirecciónDescription
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.
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.
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.
The objective is develop an understanding of pharmaceutical development, GCO standard operation procedures, policies and regulatory requirements, logistical and administrative tasks related to trial management (start-up, execution and closing phases) and patient safety in clinical trials.
The Global Trial Associate (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 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.
- Ensure inspection readiness at all times.
- 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 :
- Bachelor’s Degree in Health Sciences or related scientific field obtained between June 2022 and June 2024.
- Eligible to begin full-time employment with J&J by the assigned start date in July 2024.
- Fluent English.
- Full proficiency in MS Office applications.
- Must be permanently authorized to work in Argentina or Mexico.
- Availability to work in person in Buenos Aires or Mexico City.
Travel
While in the Site Manager rotation, approximately 50% travel.
