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Associate Site Manager
Johnson & JohnsonAssociate Site Manager at Johnson & Johnson ensuring compliance and management of clinical trial sites. Collaborating with teams for effective trial execution and monitoring from start to closure.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Acts as primary local company contact for assigned sites for specific trials.
- May participate in site feasibility and/or Site Qualification Visit.
- Attends/participates in investigator meetings as needed.
- Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies.
- Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
- Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
- Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and documented.
- Ensures site staff complete data entry and resolve queries within expected timelines.
- Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
- Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
- Active participation in regularly scheduled team meetings and trainings.
Requirements
What you’ll need- A minimum of 2 years of clinical trial on site monitoring experience is preferred.
- Demonstrated AI literacy and an AI enabled mindset, including the ability to apply AI tools responsibly in daily work to improve productivity, decision making and quality of outcomes.
- 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.
Benefits
Comp & perks- Inclusive work environment
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical Trial MonitoringData EntrySite InitiationSite Close-OutTraining Record Management
Soft Skills
CommunicationCollaborationProblem-Solving