A global healthcare leader, 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 Study Lead/Clinical Trial Lead
Job Description
Accountable for study management of phase I-III, global phase IV clinical studies for a country (or cluster if required), from planning and site feasibility through study close-out, in compliance with Novartis processes and regulatory requirements. Act as central point of communication/contact between Novartis and the Investigator and Investigational site personnel to ensure:
• that all trial related activities are conducted at site following GCP and Novartis stand-ards (processes and SOPs),
• that agreed targets (e.g. number of patients, key milestones) are met Timely and quality execution of trial related activities (e.g. key milestones, 100% of target enrolment at last patient first treatment, 100% clean data)
* Timely submission and delivery of high quality clinical trial documentation
* Data cleaning process is successfully accomplished within the required timelines in the country/cluster
* Acceptability of clinical documentation by IRB/EC and Health Authorities
* Trials are executed on time, budget and in compliance with international and local regulations and Novartis internal standards
Candidate Profile :
Degree in scientific of healthcare discipline. Master degree preferred English and country language
• Ideally 5+ years pharmaceutical industry experience with 4+ years’ strong experience in clinical research preferably clinical monitoring experience.
• Experience in a monitor role or a role overseeing clinical trials
• Strong Interpersonal skills, Project Management skills, negotiation skills
• Ability to work in a matrix environment
• Displays innovative ideas and solutions
• Highly effective in influencing others
Additional Information:
Job ID: 206748BR
Experience: 5+ years
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
Location: Mumbai
End Date: 15th March, 2017
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