Sr. Site Manager

Position Summary:
A Site Manager I (SM I) serves as the primary contact point between the Sponsor and the Investigational Site.

A Site Manager I 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, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities.

The Site Manager I will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols.

May contribute to process improvement and
training.

Principal Responsibilities:
1.

Acts as primary local company contact for assigned sites for specific trials.
2.

May participate in site feasibility and/or pre-trial site assessment visits
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.
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.
6.

Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
7.

Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
8.

Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
9.

Arranges for the appropriate destruction of clinical supplies.
10.

Ensures site staff complete data entry and resolve queries within expected timelines.
11.

Ensures accuracy, validity and completeness of data collected at trial sites
12.

Ensures 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, ensures that they are consistent with all data collected and with the information in the source documents.
13.

Maintains complete, accurate and timely data and essential d...