Clinical Trial Trainee 2023

2 weeks ago

Johannesburg, Gauteng, South Africa Johnson & Johnson Full time

Clinical Trial Trainee 2023

Sector:
Pharmaceuticals

Location:
Johannesburg, Gauteng

Join us as a Clinical Trial Trainee to help advance the future of health - and follow a career with purpose.
Imagine The Breakthroughs We'll Make Together


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, Consumer Health, Medical Devices, 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We're disrupting outdated healthcare ecosystems and infusing them with transformative ideas to help people thrive throughout every stage of their lives.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?

Pharmaceuticals:
Stop Diseases in their Tracks
Johnson & Johnson's impact in Pharma is delivered through our Janssen Pharmaceutical Companies.

These ground-breaking teams focus on preventing and curing the most devastating diseases, while shortening the time it takes for medicines to reach those in need.

Our passion is driving us to invent many more new health solutions and to innovate in fields where we can make the biggest difference.


Position summary:


The Clinical Trial Trainee (CTT) is a role designed to introduce and develop to the role of Clinical Trial Administrative (CTA), and/or Site Manager (SM) to ensure optimal management of all procedures, documents, logístical and administrative tasks related to trial start-up, execution and closing of clinical trials.

Ensures trial related activities are compliant with Global Clinical Operations (GCO) Standard Operating Procedures (SOPs), policies and local regulatory requirements.

May contribute to process improvement.

Principal Responsibilities:

  • Provide administrative and logístical support to CTA and/or SM 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.
  • Supports the local study team in performing site feasibility and/or country feasibility.
  • Maintains information in relevant systems, including Electronic Trial Master File filing.
  • Ensures current versions of the required trial documents, trialrelated materials and supplies are provided to the investigational site within required timeframes, as applicable.
  • Support CTA and/or SM in collecting/preparing documents required for study startup/submission to Independent Ethics Board/Institutional Review Board and/or Health Authority.
  • Support CTA and/or SM in collecting, processing and archiving study related documents as appropriate. Use appropriate systems to ensure file completeness at designated study milestones.
  • May assist CTA in conducting local investigator meeting or with making arrangements for the investigators participating in an international meeting.
  • Maintains and updates 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 Credo.
  • Ensure inspection readiness at all times.
  • May contribute to process improvement.

Principal Relationships:

-
Primary Reporting Structure: Reports to Functional Manager (FM).
-
Primary interfaces: Functional Manager, Local Trial Manager, Clinical Trial Adminstrative, and Site Manager(s) for assigned clinical studies.
-
Other Internal Interfaces: R&D Country Head, Clinical Trial Manager, Quality & Compliance Manager/Specialist, Contracts & Grants, Clinical Trial Assistant team, Medical Affairs.
-
External Interfaces: Investigators and their delegates at site.

Qualifications:

Education and Experience Requirements:

  • A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
  • Proficient in English language.
  • Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).
  • Strong interpersonal and negotiating skills preferred.
  • 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.

You Belong at Johnson & Johnson

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.

Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world

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