Assoc 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:
Birkerod, Capital, Denmark

Job Description:

An Associate, Site Manager is an entry level site management role with typically 0-2 years of experience.

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

An Associate, 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 Associate, 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.

May contribute to process improvement and training.

Some supervision from a more Senior, Site Manager (Senior SM or Lead SM) to help provide guidance to Associate, Site Manager.

Principal Responsibilities:
1 Acts as primary local company contact for assigned sites for specific trials.
2 May participate in site feasibility and/or Site Qualification Visit.
3 Attends/participates in investigator meetings as needed.
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.

Occasionally may require assistance or oversight from Lead, Site Manager or LTM.
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 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.
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