Caring for the world, one person at a time has inspired and united the people of Johnson & Johnsonfor over 125 years. We embrace research and science -- bringing creative ideas, products andservices to advance the health and well-being of people. We touch the lives of over a billionpeople every single day.Are you ready to impact the world?If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers anunusual experience to professionals looking for an opportunity to work with hardworking people whoshare your real passion for caring in an environment that empowers you to drive your owncareer.What you will do:Study Planning Activities:- Support in different start-up activities like site feasibility, d
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnsonfor over 125 years. We embrace research and science -- bringing creative ideas, products andservices to advance the health and well-being of people. We touch the lives of over a billionpeople every single day.
Are you ready to impact the world?
If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers anunusual experience to professionals looking for an opportunity to work with hardworking people whoshare your real passion for caring in an environment that empowers you to drive your owncareer.
What you will do:
Study Planning Activities:
- Support in different start-up activities like site feasibility, debarment process, archive thedocumentation.
- Support the preparation of study plans and of any other documents required.
Study Start Up Activities / Site start-up:
- Help in ensuring that the current versions of the documents are provided to the CROs.
- Support in IRB-IEC and AEMPS Submissions request form.
- Support in collecting and processing as appropriate the documents throughout the study throughthe contact of MAF and CROs.
- Help in the distribution, collection, reviewing, and tracking of CROs regulatory documents,agreements and training documentation.
Study Execution Activities:
- Support in ensuring that during the study all relevant study related documentation is provided toinvestigators and central IEC (if applicable) within the timelines.
- Support in maintaining the study files and trackers.
- Provide administrative and logistic support in tracking of progress of the trial, management ofstudy data, budget, organizing meetings, mailing and correspondence and other relevant tasks asappropriate, where applicable.
- Update monthly report.
- Monthly meeting with MAF and CROs to review the status of study.
- Review CROs proforma invoices
- Accompanied visit (initiation visits, monitoring visits) to the CRAs from the CROs.
Study Close Out Activities:
- Site closure: Provide administrative and lo gistic support in act ivities related to study, asappropriate, 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 ethicalaspect 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 businessneeds.
- Report every J&J product related complaint you receive to the company, accordingpolicies.
Qualifications
- Bachelor's degree in pharmacy, Biology or similar.
- Finished degree.
- Course in Clinical Trial Administration or Master in Pharmaceutical Industry (or related).
- English level B2 or higher.
- Entitled to sign an agreement with Business School or University.
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabricat Johnson & Johnson and woven into how we do business every day. Our commitment to respect thedignity 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 thatreflects the diverse markets we serve around the world and an inclusive culture that valuesdifferent perspectives and life experiences.
That is why we in Spain are working to create an inclusive environment where diverse backgrounds,perspectives and experiences are valued and each and every one of our people feels that they belongand can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Jo hnson means " You Belong"!
#JnJEMEAStudentCareers
Primary Location
Spain-Community of Madrid-Madrid-
Organization
Janssen-Cilag S.A. (formerly Janssen Sp) (7300)
Job Function
General Administration
Requisition ID
2105978222W
This employer is a corporate member of myGwork, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.
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