Role Overview
We are searching for an Associate, Site Manager (SM) who will serve as the primary contact point between the Sponsor and Investigational Sites. The Associate SM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start‑up through to site closure. Responsibilities may include assisting with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on‑site and remote monitoring and close‑out activities. The Associate, Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and Trial Delivery Manager (TDM) to ensure overall site management while performing trial related activities for assigned protocols.
Responsibilities
* Act as primary local company contact for assigned sites for specific trials.
* May participate in site feasibility and/or site qualification visits.
* Responsible for delivering activities within site initiation and start‑up, preparation and conduct of site monitoring (including remote monitoring), site management and site/study close‑out according to SOPs, Work Instructions and policies. Implement analytical risk‑based monitoring model at the site level and work with site to ensure timely resolution of issues found during monitoring visits.
* Contribute to site level recruitment strategy and contingency planning and implementation, in partnership with other functional areas.
* Ensure accuracy, validity and completeness of data collected at trial sites.
* Ensure all Adverse Events (AE)/Serious Adverse Events (SAE)/Product Quality Complaints (PQC) are reported within required reporting timelines and documented appropriately.
* Prepare trial sites for close‑out and conduct final close‑out visit.
* Track costs at site level and ensure payments are made, if applicable.
* Establish and maintain strong working relationships with internal and external partners, in particular investigators, trial coordinators and other site staff.
Qualifications and Experience
* Minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience).
* Clinical trial monitoring experience preferred, but other relevant experience may be considered.
* Oncology therapeutic area experience preferred (not essential).
* Understanding of the drug development process, including GCP and local regulatory requirements.
* Ability to work on multiple trials in parallel, if required.
* Proficient in speaking and writing English.
* Strong team member and self‑starter, capable of working independently.
* Strong communication and influencing skills to manage study sites remotely and face‑to‑face.
* Willingness to travel up to 50% (up to 2‑3 days per week) with some overnight stays as necessary.
Required Skills
* Clinical Trials Monitoring
* Extensive Traveling
* Good Clinical Practice (GCP)
Preferred Skills
* Analytical Reasoning
* Business Behavior
* Business English
* Clinical Data Management
* Clinical Trials
* Clinical Trials Operations
* Execution Focus
* Issue Escalation
* Laboratory Operations
* Oncology
* Process Improvements
* Process Oriented
* Project Support
* Regulatory Environment
* Research and Development
* Research Ethics
* Study Management
* Time Management
Benefits
We offer a competitive salary and extensive benefits package. The health and well‑being of our employees is a priority. We provide a flexible working environment and value work‑life balance. Career development opportunities are available.
Equal Opportunity Employer
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will provide reasonable accommodation for individuals with disabilities to participate in the job application or interview process, perform crucial job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.
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