Lead Clinical Research Associate (Lead Site Manager)

Johnson & Johnson is currently seeking a Lead Site Manager - Lead Clinical Research to join us located in Warsaw / Poland.

About Johnson & Johnson

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/.

Description:

A Lead, Site Manager is considered as the most senior site management role with typically more than 6 years of experience.

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

Additionally, a Lead, Site Manager is generally expected to have outstanding capability to engage with key sites and their respective personnel.

A Lead Site Manager ensures inspection readiness at trial sites by adhering to clinical trial protocols, company SOPs, GCP, and relevant regulations from start-up to site closure.

Responsibilities include site selection, qualification assessment, subject recruitment and retention planning, site initiation, monitoring (both on-site and remote), and close-out activities.

The Lead Site Manager collaborates with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and Trial Delivery Leader (TDL) for effective site management while executing activities related to assigned protocols.

A Lead, Site Manager is expected to lead process improvements at country, regional, and global levels as well as training and mentoring of other Site Managers.

A Lead, Site Manager is expected to operate independently and be able to perform clinical trial tasks proficiently and is expected to identify opportunities for streamlining processes.

A Lead, Site Manager can support leadership at a study level as requested.

Principal Responsibilities:

1.

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 great proficiency.

Also expected to oversee, train, mentor more junior Site Manager and support functional manager with completion of junior site manager accompanied site visits (ASVs) as required.

2.

Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.

Ma...