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Opportunity for Senior Clinical Manager in Novartis

 

Clinical courses

Novartis (NYSE: NVS) is a world leader in the research and development of products to protect and improve health and well-being. The company has core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health.
Headquartered in Basel, Switzerland, Novartis employs nearly 115 000 people in over 140 countries worldwide to help save lives and improve the quality of life. The Group is present in India through Novartis India Limited, listed on the Mumbai Stock Exchange and its wholly owned subsidiaries Novartis Healthcare Private Limited, Sandoz Private Limited and Chiron Behring Vaccines Private Limited.

Post: Senior Clinical Manager

Job Description
1. Support GTL in ensuring all operational trial deliverables are met according to timelines, budget, procedures and quality standards, development of study tools, guidelines and training materials; management of clinical study material, implementation of issue resolution plan.
2. Support GTL in preparation of clinical outsourcing specifications and in the follow up with day to day operation with vendors.
3. Support the development, management and tracking of trial budget working closely with the GTL and FinOM.
4. Support CS in the preparation of training materials and presentations related to the planning and conduct of the trial.
5. Support GTL in the management of the trial master file. 6. Support GTL in managing interactions with the clinical trial team and CPOs.
7. Support GTL in management of trial allocation and coordination of activities leading to site initiation.
8. Support Medical Lead/CS/GTL by generating data cleaning reports and reviewing non medical data as assigned.
9. Support the GTL in trial close out activities.
10. Draft CTT meeting minutes. Participate in clinical trial team meetings.
11. May organize and chair trial sub-teams within the scope of his/her delegated responsibilities.
12. Assist CS/Medical Lead with program level activities (i.e., DSUR, PSUR, IND updates, coordination of Advisory Boards), and support the implementation and management of trial monitoring boards (i.e., Adjudication Committees and Data Monitoring Committees) as assigned.
13. Responsible for implementation of best practices within Global Clinical Operations.
14. Participate in the on-boarding, mentoring and training of new staff.

Candidate Profile
Bachelor’s degree or equivalent qualification in life science/healthcare required if accompanied with > 2 years experience in clinical research. Fluent English (oral and written)
• Involvement in cross-functional, multicultural and international clinical trial teams and demonstrated capabilities in supporting operational trial activities.
• Good communication, organization and tracking skills.
• Proven networking skills and ability to share knowledge and experience amongst colleagues.
• Proven ability to work both independently or in a team setting, and to meet set goals by managing own timelines.
• Knowledge of Good Clinical Practice; basic knowledge of clinical trial design; understanding of the overall drug development process.
• Basic knowledge of principles for trial budgeting is preferable.
• Basic knowledge of Therapy Area preferable.

Additional Information:
Experience: 2-3 Years
Location:
India
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area:
Development & Medical
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID:
159484BR
End Date: 10th March, 2015

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