DirecciónDescription
At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.
Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.
When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.
If you're passionate about your career every single day, we'd love to hear from you!
We invite you to read this Job Description and apply if you are passionate about the position and meet the requirements.
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., rheumatoid arthritis, irritable bowel disease and psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, Hepatitis C and tuberculosis), cardiovascular and metabolic diseases (e.g., diabetes) and Pulmonary Arterial Hypertension (PAH) and Rare Diseases.
Site Manager will be the primary contact point between the sponsor and the investigation site. A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock. Your responsibilities include site selection, pre trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out. Partner with the CTA/IDA, LTM and GTM to ensure overall site management while performing tasks for assigned protocols. Contribute to process improvement, training and mentoring of other Site Managers.
Key Responsibilities:
. Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
. Acts as primary local company contact for assigned sites for specific trials.
. Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out.
. Ensures site partners are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
. Ensures site study supplies are adequate for trial conduct and that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented. Also arranges the appropriate destruction of clinical supplies.
. Ensures accuracy, validity and completeness of data collected at trial sites.
. Maintains complete, accurate and timely data and essential documents in systems utilized for trial management.
. Writes visit reports and uploads into eTMF within 5 working days for review and approval. Complete follow-up letter to communicate relevant information and required corrective action to the investigator and his/her team with 15 working days.
. Reviews TCF for completeness and ensures archiving retention requirements, including storage in a secure area at all times.
. Work closely with LTM to ensure CAPA is completed for QA site audits.
. Prepares trial sites for close out, conduct final close out visit.
Qualifications
1) Education level required: Bachelor's degree in a health or science related field.
2) Desirable experience as Site Manager (CRA) or at least background in science field.
3) Good knowledge of ICH-GCP, company SOP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
4) Strong IT skills in appropriate software and company systems.
5) Availability to travel (25% of the time).
6) Proficient in speaking and writing in English (intermediate level).
7) Location of the role: Belgrano, CABA. Argentina.
