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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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Study Planning Activities

• Trial documentation: Support the preparation of study files and of any other document required pre-trial.

Study Start Up Activities / Site start-up

• Support the Trial Manager (TM) or the Site Manager (SM) in EU-CTR Submission Preparation.

• Help the SM in obtaining site related trial documents.

• Support the TM/SM in collecting and processing as appropriate the IFDF and related documents throughout the trial.

• Help in the distribution, collection, reviewing, and tracking of regulatory documents, agreements, and training documentation.

Study Execution Activities

• Support TM/SM in ensuring that during the trial all relevant trial related documentation is provided to investigators and EC (if applicable) within the timelines.

• Support the TM/SM in maintaining the study files.

Study Close Out Activities

• Site closure: Provide administrative and logistic support to the TM/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

Required Skills:

Preferred Skills:

The anticipated pay range and benefits for this position is: