Senior Site Manager

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
R&D Operations

Job Sub Function:
Clinical Trial Support

Job Category:
Professional

All Job Posting Locations:
Warsaw, Masovian, Poland

Job Description:

Position Summary:
A Senior Site Manager is a mid-level site management role with typically 3-5 years of experience.

This role serves as the primary contact point between the Sponsor and the Investigational Site.

A Senior, Site Manager 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 Senior, Site Manager will 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.

A Senior, Site Manager may contribute to process improvement, training and mentoring of other Site Managers.

A Senior, Site Manager is generally expected to be able to operate independently with little or limited supervision.

Principal Responsibilities:

1.

Acts as primary local company contact for assigned sites for specific trials.
2. Actively May participate in site feasibility and/or Site Qualification Visit.
3. Attends/participates in investigator meetings as needed, may be expected to help prepare meeting materials and may be required to present at the IM.
4. 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.

Responsible for the implementation of analytical risk-based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.

Able to implement and execute all tasks independently with little or limited supervision.
5. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.

Responsible in close collaboration...