GLOBAL TRIALS ASSOCIATE

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.
.
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.
Qualifications Education and Experience Requirements.
▪ Must be graduating no more than 12 months prior to the target start date of July , with a Bachelor’s or Master’s degree (e.
., BA, BS, MS), in Health Sciences or related scientific field.
▪ Minimum GPA 3.
.
or is a U.
.
Junior Military Officer who has completed a government assignment that did not exceed six years).
▪ One plus years of work experience preferred.
▪ Requirement for IT literacy relevant to Corporate and Clinical Operations.
▪ Must be permanently authorized to work in the U.
.
and must not require sponsorship at the time of hire or in the future.
Other Skills.
▪ Strong verbal and written communication and presentation skills.
▪ Analytical and a real problem solver.
▪ Willingness to learn in a dynamic environment and stay abreast of new technologies.
▪ Strong interpersonal, leadership, and negotiating skills.
▪ Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
▪ Ability to perform activities in a timely and accurate manner.
▪ Expert proficiency with Word, Power Point, Excel.
Travel.
While in the Site Manager rotation, approximately 25% travel.