Clinical Trial Associate

**Summary**:
Designs and coordinates the overall direction of clinical development projects. Coordinates activities of associates and investigators to ensure compliance with protocol and overall pre-clinical objectives. Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings. May also travel to field sites to supervise and/or coordinate clinical studies. May be responsible for planning clinical trial registration and disclosure postings. May write protocols. -Administers the clinical trial results registration and disclosure process. Ensures compliance due dates and registration timelines are met. Collaborates with clinical trial study teams to compile data required for results disclosures. Maintains a working knowledge of the standard operating procedures for the website registry process. Develops content for internal training materials and job aids.

**About the Role**:
Key Responsibilities
- 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

Role requirements:

- Commercial or medical training (e.g., vocational qualification, bachelor’s degree), Medical records administrator or equivalent education, preferably with experience in clinical operations.
- Ideally several years of working experience with 1+ years´ of experience in clinical operations.
- Understanding of clinical drug development with particular emphasis on trial set-up, and contracting
- 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.
- Self-motivated, structured and committed way of working.
- Ability to prioritize and high coordination skills
- Demonstrated collaboration and communication skills.

Why Novartis:
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Division

Development

Business Unit

Universal Hierarchy Node

Location

India

Site

Mumbai (Head Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.