Clinical Trial Associate

1 week ago

Mumbai, India Novartis Full time

100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine - imagine the impact you could have as [Role] #GCO
Job Purpose:
The Clinical Trial Associate (CTA) supports SSO Study Start-Up Manager and SSO Clinical Project Manager in assigned studies during set-up and whole study lifecycle in compliance with Novartis processes, GCP/ICH and regulatory requirements.
Accountabilities What are the key deliverables and accountabilities of the role?
- Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities as applicable. Sets-up systems. Supports vendor selection, TPRM process, SIM entries
- IF and TMF management (country and site TMF); set-up and maintenance according to regulatory and Novartis requirements; document oversight and tracking. Supports Vendor set-up as applicable. Checks site “Green Light” completeness and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
- Supports preparation and translation of ICF into local languages (including vendor management if necessary). Supports preparation of patient facing material. Responsible for completeness of uploaded trial related documents into CREDI/SUBWAY, including archiving of paper TMFs.
- Supports country SSU strategy in close collaboration with SSU Team Lead and SSU Managers to ensure SSU timelines and deliverables are met according to country commitments. Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements. Provides logistic support to SSU CRA, CRA, CPM, SSU Manager in all phases of the clinical trial
- Implements innovative and efficient processes which are in line with Novartis strategy

Activities & Interfaces How does this role operate within, interact with and impact the organization?
Interfaces with external vendors and sites to ensure issues resolution as needed.
Key Performance Indicators How will we measure success in this role?
1. Performance against study commitments at the country level, including set-up/delivery of trials
per defined timelines and milestones (IRB/IEC & HA approval, RIS, SIV, system updates, TMF) and
data quality requirements
2. Delivery of study milestones in adherence to prevailing legislation, ICH/GCP, IRB/IEC, Health
Authority and SOP requirements
3. Timely submission and delivery of high-quality clinical trial documentation/data

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

Education: - Commercial or medical training (e.g., vocational
qualification, bachelor’s degree), Medical records
administrator or equivalent education, preferably with
experience in clinical operations
Languages: - Fluent in both written and spoken English, local language
as needed
Experience/Professional
requirement:

- Ideally several years of working experience with 1+ year'

of experience in clinical operations
- Understanding of clinical drug development with particular

emphasis on trial set-up, and contracting
Competencies: - Profound knowledge of MS Excel, MS Word, MS
PowerPoint, ideally knowledge in SAP
- Understanding of the international aspects of drug

development process, including strong knowledge of
international standards (GCP/ICH), health authorities
(FDA/EMA), local/National Health Authorities regulations
and Novartis standards
Skills & Knowledge:

- Strong process and system understanding
- Self-motivated, structured and committed way of working
- Ability to prioritize and high coordination skills
- Demonstrated collaboration and communication skills

**Division**

Global Drug Development

**Business Unit**

GCO GDD

**Country**

India

**Work Location**

Mumbai

**Company/Legal Entity**

Nov Hltcr Shared Services Ind

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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