Job Information
J&J Family of Companies Internship Global Clinical Operations in Lisbon, Portugal
Internship Global Clinical Operations - 2406182312W
Description
Johnson & Johnson is currently seeking a GCO intern to join our Global Clinical Department located in Lisbon.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .
What you will do:
- Study Planning Activities
Site Identification: Support the local study team in performing country and site feasibility
Trial documentation: Support the preparation of study files and of any other document required pre-trial.
- Study Start Up Activities / Site start-up
Help LTM/SM in ensuring that the current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site.
Support the LTM or the SM in ECs and Health Authorities Submissions.
Help the SM in obtaining site related trial documents.
Support the LTM/SM in collecting and processing as appropriate the IFDF and related documents throughout the trial.
Assist the LTM/SM in conducting local investigator meeting or in making arrangements for the investigators participating in an international meeting as applicable
Help in the distribution, collection, reviewing, and tracking of regulatory documents, agreements and training documentation.
- Study Execution Activities
Support LTM/SM in drug distribution process, where applicable.
Support LTM/SM in ensuring that during the trial all relevant trial related documentation is provided to investigators and central IEC (if applicable) within the timelines.
Support the LTM/SM in maintaining the study files.
Provide administrative and logistic support to LTM/SM in tracking of progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence and other relevant tasks as appropriate, where applicable
- Study Close Out Activities
- Site closure: Provide administrative and logistic support to the LTM/SM in activities related to study/site closure, as appropriate, and follow up of all items identified.
- General Activities
Base all actions on Credo. Protect the rights of others, protect privacy and company assets.
Work in line with the HCC, company policies and procedures, including SOPs, having the ethical aspect in mind. Comply with ICH-GCP and all applicable local laws and regulations.
Maintain communication with relevant parties within and outside the company
Actively follow trainings to ensure adequate qualification
Regularly update information in applicable systems and templates
Contribute to maintain quality standards and timelines that are consistent with business needs
Report every J&J product related complaint you receive to the company, according policies
We offer:
Duration of the internship - 12 months
Start date : September 2024
Full time
Location : Lisbon
Qualifications
Degree in Pharmacy, Biology, Biotechnology, Biochemistry or similar.
Studying the Master's degree in clinical trial monitoring.
English B2-C1.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
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Primary Location Europe/Middle East/Africa-Portugal-Lisbon-Lisbon
Organization Janssen-Cilag Farmaceutica, Lda. (7290)
Job Function Non-LDP Intern/Co-Op
Req ID: 2406182312W
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