Associate Site Manager

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Job Function:
R&D Operations

Job Sub Function:
Clinical Trial Support

Job Category:
Professional

All Job Posting Locations:
Mumbai, India

Job Description:

Key requirements: An Associate, Site Manager is an entry level site management role with typically 2 years of on site monitoring experience.

This role is in-house SM based role for Study Start up activities with limited travel for site feasibility activities only.

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 vi...