30 oct
|
7257 Syneos Health Argentina
|
Mendoza
30 oct
7257 Syneos Health Argentina
Mendoza
Milestone One Site Coordinator supports trial sites in all related activities according to ICH-GCP, protocol requirements within Study specific defined timelines and enrollment goals.
In this role you will:
- Act as the main line of communication between the Sponsor or CRO and the site.
- Ensure response to feasibility questions are provided in due time.
- Assist in scheduling and preparation for all types of monitoring visits at the medical institution/research center.
- Be present and available to respond to monitors during all types of monitoring visits conducted at the medical institution.
- Track patient enrollment and actively support the medical site and CRO/Sponsor team in meeting project timelines and enrollment goals.
- Maintain study specific and general tracking of documents at the site level.
- Accurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site.
- Timely reporting and follow up on Reportable Adverse Events and Protocol Deviations.
- Proper handling, accountability and reconciliation of investigational products and clinical supplies.
- Collect, handle and maintain all site-specific regulatory documents as needed.
- Facilitate and support the contract and budget negotiations at the site level.
- Support Investigator and Site payments and processes as needed.
- Schedule and/or perform study procedures as per study requirements and delegation of responsibilities.
- Prepare for and participate in onsite study audits or regulatory agency inspections.
- Build and sustain long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions).
Qualifications
- College or university degree in Life Science,
preferably in pharmacy, nursing or lab analytics.
- Minimum of 3 years of on-the-job experience in a clinical trial environment, where relevant experience has been gained in clinical trials, clinical terminology, and medical research working in the role of a Study Coordinator or similar function.
- Upper-Intermediate level of English, with the ability to work in a integral team environment.
- Ability to work in a fast-paced environment, with short timelines and multiple tasks to be completed simultaneously.
- Ability to effectively communicate in stressful situations and demonstrate the ability to problem-solve in an effective and efficient manner.
- Flexibility in working hours may be required depending on the schedule of study procedures and/or patient visits.
- Strong interest in professional growth and development within the company.
Additional Information
Lead Analyst, Traceability and Labeling Controls
Mendoza J&J; Family of Companies
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.
Job Function:
Data Analytics & Computational Sciences
Job Sub Function:
Business Intelligence
Job Category:
Professional
All Job Posting Locations:
Mendoza, Argentina
Job Description:
We are searching for the best talent for a Lead Analyst, Traceability and Labeling Controls to be based in Argentina, New Brunswick, NJ; Raritan, NJ; or Titusville, NJ.
Purpose: The role supports GTC T&LC; platforms and programs in the Serialization & Traceability and GS1 standards, by leading the scoping, planning, and execution of activities required to meet new and evolving regulatory and customer requirements.
This position partners with cross functional teams, business stakeholders, technology groups, and external customers across both Innovative Medicine and MedTech to translate requirements into actionable steps and ensure operational excellence. It also provides day-to-day leadership of base business operations, team oversight, and delivery of high-quality data and digital capabilities.
You will be responsible for:
+ Lead base business team including direct responsibility for contract resource(s) and J&J; associate(s).
+ Lead scoping activ
📌 Senior Clinical Trial Site Lead (Mendoza)
🏢 7257 Syneos Health Argentina
📍 Mendoza