Global Trials Associate
vor 1 Monat
This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
Please do not contact the recruiter directly.
Position Summary:
The GCO Leadership Development Program consists of 12 months of dynamic rotations with indepth 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, logistical 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:
1 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.
2 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.
3 Maintain information in relevant systems, including electronic filing (electronic Trial Master File: eTMF).
4 Ensure current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes, as applicable.
5 Support CTA, SM and/or LTM in collecting/preparing documents required for study start-up/ submission to Ethics Committee/IRB and/or Health Authorities.
6 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.
7 May assist team in conducting local investigator meeting or with planning for the investigators participating in an international meeting.
8 Maintain and update contact information in relevant systems to ensure appropriate safety updates distribution.
9 Comply with all training requirements, company policies & procedures and all applicable laws and regulations.
Always act aligned with J&J Credo.
10 Ensure inspection readiness at all times.
11 May contribute to process improvement.
12 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.
This is not an exhaustive, comprehensive listing of job functions.
May perform other duties as assigned.
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