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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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial site monitoring, ensuring compliance with GCP, SOPs, and local regulations while effectively managing site operations and staff training. Proficient in utilizing AI tools to enhance productivity and decision-making in trial management.
Highest-signal resume keywords
Clinical Trial Site MonitoringGood Clinical Practice (GCP)AI LiteracyData ManagementSite Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial MonitoringData EntrySite InitiationSite Close-OutTraining Record Management
Soft Skills
CommunicationCollaborationProblem-Solving
Tools & Technologies
Trial Management SystemsMonitoring GuidelinesCompany Software
Industry Keywords
Site FeasibilitySite Qualification VisitRecruitment StrategyTherapeutic Area ExperienceLocal Laws and Regulations
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