Description
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:
R&D OperationsJob Sub Function:
Clinical Trial Project ManagementJob Category:
ProfessionalAll Job Posting Locations:
Istanbul, TurkeyJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Principal Responsibilities:
- Serve as the primary local sponsor contact for assigned trial sites with appropriate guidance and support from senior team members to maintain effective site relationships.
- Support site selection, feasibility, and qualification activities, including participation in Site Qualification Visits as required.
- Act as a point of contact for site management activities, ensuring effective communication and escalation of issues when needed.
- Execute site start-up, initiation, on-site/remote monitoring, ongoing site management, and close-out activities under supervision, in compliance with protocol, SOPs/WIs, GCP, and applicable regulations.
- Assist in implementing risk-based monitoring approaches at the site level, identifying issues and supporting timely escalation and resolution.
- Ensure site personnel are appropriately trained and that training documentation is complete and up to date across all trial phases, with support from LTM/central teams.
- Support recruitment and retention efforts by working with sites and cross-functional stakeholders to meet study enrollment targets.
- Ensure appropriate handling, tracking, and documentation of investigational and non-investigational products, including storage, inventory, and returns.
- Contribute to data quality and timelines by supporting accurate data entry, query resolution, and completeness of clinical trial data.
- Maintain inspection readiness by ensuring essential documentation is complete and current (e.g., monitoring reports, TMF documentation) and supporting audits, inspections, CAPA activities, and continuous improvement initiatives.
- And not limited to,
Education and Experience Requirements:
- A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences, or related scientific field (or equivalent experience) is required.
- A minimum of 1 year of clinical trial monitoring experience is required. 1-2 years of clinical trial monitoring experience is preferred. However, other relevant experiences and skills maybe considered by the hiring manager when considering the candidate’s eligibility.
- Specific therapeutic area experiences an added advantage.
- Basic working knowledge of GCP, company SOPs, local laws, and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
- Strong IT skills in appropriate software and company systems.
- Willingness to travel with occasional overnight stay away from home.
- Proficient in speaking and writing the country language and English. Good written and oral communication.
Required Skills:
Preferred Skills:
Analytical Reasoning, Analytics Dashboards, Business Behavior, Clinical Data Management, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trials, Execution Focus, Laboratory Operations, Medical Knowledge, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics, Training Administration