Senior Site Manager

A Site Manager II (SM II) serves as the primary contact point between the Sponsor and the Investigational
Site. A Site Manager II 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. Site Manager 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. A Site Manager II may
contribute to process improvement, training and mentoring of other Site Managers.

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.
LD Version 1.0 dated 18 October 2017 (FINAL) For Internal Use Only
:
Specialist 3, Clinical Trial Admin/Oper (PG 25)
Page 2 of 3
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 documents in relevant systems utilized for
trial management.
14. Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter
in accordance with the SOPs. Promptly communicates relevant status information and issues to
appropriate stakeholders.
15. Reviews study files for completeness and ensures archiving retention requirements are met, including
storage in a secure area at all times.

---