Associate Site Manager

1+ years

Not Disclosed

Delhi Mumbai

10 July 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job TitleAssociate Site Manager - Mumbai / Delhi
FunctionR&D Operations
Sub FunctionClinical Trial Support
CategoryAnalyst, Clinical Trial Support (P4 - E24)
LocationMumbai, Maharashtra, India
Date PostedJul 25 2024
Requisition Number2406202986W

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Description

Global Clinical Operations (GCO)
Position Title*: Associate, Site Manager
(*Title may vary based on Region or Country requirements)

Position Summary:

A Site Manager serves as the primary contact point between the Sponsor and the Investigational Site.
A 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, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site
and remote monitoring and close-out activities. The 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. 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 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.
16. Collaborates with LTM for documenting and communicating site/study progress and issues to trial
central team.
17. Attends regularly scheduled team meetings and trainings.
18. Complies with relevant training requirements. Act as local expert in assigned protocols. Develops
therapeutic knowledge sufficient to support role and responsibilities.
19. Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for
Quality Assurance (QA) site audits and for quality issues identified at the site during routine
monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
20. Prepares trial sites for close out, conduct final close out visit.
21. Tracks costs at site level and ensure payments are made, if applicable.
22. Establishes and maintains good working relationships with internal and external stakeholders in
particular investigators, trial coordinators and other site staff.
23. May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as
required/appropriate.
24. Acts as a point of contact in site management practices.
25. May contribute to process improvement and training.
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

Principal Relationships:

Primary Reporting Structure: Reports to a Functional Manager
Primary interfaces: Functional Manager, CTA, LTM and CTM.
Other Internal Interfaces: R&D Country Head, Therapeutic Area Manager/Physician, Quality & Compliance
Manager/Specialist, Training Manager, Contracts & Grants, Local Drug Safety Officer (where required) and
Site Manager team.
External Interfaces: Investigators and their delegates at site (trial site personnel).

Qualifications

Education and Experience Requirements:

A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience)
is required.
A minimum of 1 year of clinical trial monitoring experience is preferred, however, other relevant experiences
and skills may be considered by the hiring manager when considering the candidate’s eligibility.
Specific therapeutic area experience may be required depending on the position.
Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and
associated protocol specific procedures including monitoring guidelines.
Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight
stay away from home.
Proficient in speaking and writing the country language and English. Good written and oral communication.

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