Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Clinical Research Associate
Job Description
1. Nominate new sites for clinical trials; analyze capability and make recommendation for trial inclusion
2. Assume ambassadorial role to facilitate communication between sites and Novartis line functions and increase value proposition to investigators
3. Facilitate preparation and collection of site level documents; resolve problems as required
4. Execute site initiation and training
5. Implement total site management including monitoring visits, regulatory assess-ment, drug supply management and resolution of site problems to ensure compli-ance
6. Track trial execution milestones; identify problems; resolve issues and escalate as appropriate
7. Manage recruitment and execute contingency plans, as needed
8. Complete preparation/generation of study monitoring reports
9. Manage data at the site; resolve technical and content issues to achieve aggressive database lock targets
10. Implement site closeout activities across all sites and performs SCV for own sites in a timely manner
11. Act as local and/or global CRA lead, author global monitoring plan and Local SOPs as assigned
12. Act as a mentor to new associates for purposes of field training, as assigned
13. Participate in multi-disciplinary teams within CPO and globally to evaluate and im-plement process improvement
14. May be involved with special projects and work streams
15. Mentor new associates.
Candidate Profile
Degree in scientific of healthcare discipline. Master degree preferred Fluent English (oral and written).
• Ideally 4+ years pharmaceutical industry experience with 3 years strong experience in clinical research
• Experience in a monitor role or a role overseeing clinical trials
• Strong Interpersonal skills
• Strong Project Management and leadership skills
• Working experience in a global team, team player
• Ability to work in a matrix environment
• Displays innovative ideas and solutions
• Highly proficient in negotiation skills
Additional Information:
Job ID: 235368BR
Location: Mumbai
Division: Global Drug Development
Business Unit: GDO GDD
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Research & Development
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