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**Job Function: **
R&D Operations
**Job Sub Function: **
Clinical/Medical Operations
Job Category:
Professional
All Job Posting Locations:
Texas (Any City)
Job 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
Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Site Manager - Cross TA & Immunology Central U.S. This position can be located remotely in Texas to support the Central Region (TX, LA, MS, AL, AR, IL, MN, IA, KS, MO, TN, KY, WI, OK, IN) of the United States.
We are searching for the best talent for Associate Site Manager, Clinical Trial Support.
Purpose: The Associate Site Manager (Associate SM) will serve as the primary contact point between the Sponsor and the Investigational Site. 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. This individual may assist with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. Partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement and training. Some supervision from a more Senior Site Manager (Senior SM or Lead SM) to help provide guidance.
Principal Responsibilities:
- Act as primary local company contact for assigned sites for specific trials.
- Actively participate in site feasibility and/or Site Qualification Visits (SQVs).
- Attend/participate in investigator meetings as needed.
- Execute 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. Implementation of analytical risk-based monitoring model at the site level and work with the site to ensure timely resolution of issues found during monitoring visits. Occasionally may require assistance or oversight from Lead SM or LTM.
- Ensure site staff are trained, and the corresponding training records are complete and accurate at any point during all trial phases. Collaborate closely with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe.
- Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
- Ensure site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
- Ensure that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
- Arrange for the appropriate destruction of clinical supplies.
- Ensure site staff complete data entry and resolve queries within expected timelines.
- Ensure accuracy, validity and completeness of data collected at trial sites.
- Ensure that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure that they are consistent with all data collected and with the information in the source documents.
- Maintain complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
- Fully document trial related activities, in particular monitoring. Write visit reports and follow-up letters in accordance with the SOPs. Promptly communicate relevant status information and issues to appropriate stakeholders.
- Review study files for completeness and ensure archiving retention requirements are met, including storage in a secure area at all times.
- Collaborate with LTM for documenting and communicating site/study progress and issues to trial central team.
- Active participation in regularly scheduled team meetings and trainings. Provide feedback as appropriate. May be asked to lead/provide leadership at these meetings.
- Comply with relevant training requirements. Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support role and responsibilities.
- Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. Compliance Monitoring Visit (CMV).
- Prepare trial sites for close out, conduct final close out visit.
- Track costs at site level and ensure payments are made, if applicable.
- Establish and maintain good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff.
- May participate in the Health Authority (HA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission and notification processes as required/appropriate.
- Act as a point of contact in site management practices.
- May contribute to process improvement and training.
Qualifications:
- A minimum of a Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or related scientific Discipline is required.
- A minimum of 1 year of clinical trial monitoring experience is required.
- Experience with Phase II and Phase III Clinical Trials is preferred.
- Basic working knowledge of GCPs, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures, including monitoring guidelines, is required.
- Strong computer skills in appropriate software applications and related clinical systems required.
- Must have strong written and oral communication skills.
- Willingness to travel up to 60% with overnight stay away from home is required.
- A valid Driver's License issued in one of the 50 United States and a good driving record is required.
#LI-Remote
This job posting is anticipated to close on May 20, 2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
**Required Skills: **
Preferred Skills:
Analytical Reasoning, Business Behavior, Clinical Data Management, Clinical Operations, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trials Operations, Communication, Ethical and Participant Safety Considerations, Execution Focus, Innovation, Laboratory Operations, Office Administration, Preclinical Research, Project Management, Research and Development, Study Management