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Senior Site Manager
Johnson & JohnsonSenior Site Manager managing clinical trial operations in India for Johnson & Johnson. Ensuring compliance with regulations and coordinating site activities for successful trial outcomes.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial monitoring, site management, and adherence to GCP and SOPs. Proficient in utilizing AI tools to enhance productivity and decision-making while ensuring effective communication with site personnel.
Highest-signal resume keywords
Clinical Trial Monitoring ExperienceStrong Knowledge of GCPAI LiteracySite ManagementEffective Communication
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 MonitoringSite ManagementData ManagementAdverse Event ReportingRecruitment Strategy ImplementationTraining Record MaintenanceCost TrackingProtocol ComplianceTrial DocumentationProblem Solving
Soft Skills
Good Written CommunicationGood Oral CommunicationEngagement with Site PersonnelAbility to Work on Multiple Trials
Tools & Technologies
Clinical Trial Management SystemsAI ToolsMonitoring Guidelines SoftwareReporting DashboardsTraining Management Systems
Industry Keywords
Good Clinical PracticeSite InitiationSite QualificationAdverse EventsSerious Adverse EventsProduct Quality ComplaintsLife SciencesPharmacyNursingRegulatory Compliance
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Acts as primary local company contact for assigned sites for specific trials.
- Actively May participate in site feasibility and/or Site Qualification Visit.
- Attends/participates in investigator meetings as needed, may be expected to help prepare meeting materials and may be required to present at the IM.
- 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.
- Proactively ensures that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
- Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
- Tracks costs at site level and ensure payments are made, if applicable.
Requirements
What you’ll need- 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 2 years of clinical trial monitoring experience is required.
- 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.
- Strong 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.
- Ability to work on multiple trials in parallel.
- Demonstrated capability to consistently deliver clinical trials.
- Demonstrated capability to effectively communicate and engage with sites and sites personnel.
- Demonstrated problem solving capability.
Benefits
Comp & perks- Inclusive work environment
- Training and mentoring opportunities