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: Expert 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. Prepare clinical outsourcing specifications and manage vendors in collaboration with GTL.
3. Contribute to the development, management and tracking of trial budget working closely with the GTL and FinOM.
4. In collaboration with CS / Medical Lead, prepare 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. Write clinical trial team meeting minutes. Could deputize for the GTL at Clinical Trial Team meetings.
11. May organize and chair trial sub-teams within the scope of his/her delegated responsibilities.
12. Support 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.
Minimum requirements:
Bachelor’s degree or equivalent qualification in life science/healthcare required if accompanied with > 4 years experience in clinical research. Fluent English (oral and written)
• Experience in cross-functional, multicultural and Ex CM 2 requirement: international clinical trial teams and demonstrated capabilities in supporting operational trial activities.
• Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
• Proven networking skills and ability to train colleagues.
• Proven ability to work both independently or in a team setting, including a matrix environment.
• Knowledge of Good Clinical Practice; thorough knowledge of clinical trial design; understanding of the overall drug development process.
• Knowledge of principles for trial budgeting.
• Basic knowledge of Therapy Area preferable.
Additional Information:
Job ID: 197093BR
Experience: 4+ Year
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
Location: Hyderabad
End Date: 22nd October, 2016
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