19 Aug
|
Novotech Global
|
Bengaluru
19 Aug
Novotech Global
Bengaluru
The Clinical Lead Analyst (CLA) works collaboratively with Clinical Lead in
managing clinical delivery of the project, by closely monitoring the clinical
deliverables, project performance & schedule, compliance, risks, quality of the
project.
Minimum Qualifications & Experience:
* Requires minimum of 3 years of work experience, with minimum 1.5 years of
relevant experience in a clinical research organization or equivalent role.
* Basic knowledge of applicable research and regulatory requirements, i.e.
International Conference on Harmonization - Good Clinical Practice and
relevant local laws, regulations, and guidelines.
* Knowledge of Microsoft Applications including but not limited to Microsoft
Excel, Word and PowerPoint.
* Exposure to basic data analysis required for projects during start-up,
maintenance and close outs.
Certification course in Clinical Research will be an added advantage.
RESPONSIBILITIES
* CLA provides analytics, reports, status update, risk alerts and required
mitigation recommendations to the Clinical Lead and rest of the clinical team
throughout the lifecycle of the project.
* CLA supports the Clinical Lead with tools to ensure productive oversight of
clinical deliverables of a project and to ensure adherence to project scope
(clinical), protocol, SOPs, applicable regulations, and study plans (CMAP, PD
management plan, recruitment plan, IQRMP, IP management, etc.) focusing on
applications, analytics, therapeutics, regional requirements, blinding
processes, project milestones, and quality perspectives.
* Conducts periodic review of project KPIs, shares status/analysis, follows up
for open action items in accordance to clinical lead’s directions.
* Monitors site-performance parameters at study level and makes recommendations
for timely corrective actions under the guidance of Clinical Lead.
* Evaluates the quality of study processes (clinical) and supports the Clinical
in monitoring quality of conduct of the protocol and adherence to
📌 Clinical Lead Analyst (Bengaluru)
🏢 Novotech Global
📍 Bengaluru