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 Manager / Sr. Clinical Manager
Job Description:
Responsible for supporting, under the leadership of the Clinical Trial Head (CTH), all aspects of clinical trial(s) (Phase II through lifecycle management) and program level activities as assigned.
Major Accountabilities:
1. Support CTH in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Assigned responsibilities can include development of specific sections of protocol and related documents; development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
2. Support CTH in preparation of clinical outsourcing specifications and in the follow-up with day to day operational activities with the Contract Research Organization(s) (CROs).
3. Support CTH in managing interactions with Global Clinical Development Operations and other relevant functions including Drug Supply Management and Novartis local medical organizations.
4. Update regularly all trial information databases and tracking systems in order to manage accuracy of information.
5. Contribute to the ongoing scientific review of the clinical trial data during the course of the trial.
6. Support CTH in delegated aspects of trial data analysis and reporting.
7. May assist in program level activities (e.g., tracking of CD&MA brand-related publications, development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions).
Candidate Profile:
• Bachelor degree or equivalent education/degree in life science/healthcare is required if no previous experience in clinical research.
or
• Associate degree or equivalent education/degree qualification in life science/healthcare required if accompanied by ≥4 years of involvement with clinical study planning, execution, reporting and publishing activities (either at a local medical organisation investigational site, pharmaceutical company/CRO, or clinical fellowship program).
Languages:
Fluent English (oral and written)
Experience:
• Good communication, organization and tracking skills.
• None to basic knowledge of Good Clinical Practice; basic knowledge of scientific principles.
Additional Information:
Experience: 4-5 years
Location: Hyderabad / Secunderabad
Education: B.Pharm, B.Sc, MBA
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Development & Medical
Therapeutic Area: Cardiovascular and Metabolism
Business Unit: Global Product Strategy & Commercialization
Job Type: Full Time
Employment Type: Permanent
Job ID: 75681BR
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