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: 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 preparation of clinical outsourcing specifications and manage vendors in collaboration with the GTL and the Vendor Logistics Group.
3. Support the development and tracking of trial budget working closely with the GTL, Global Program Operations Manager (GPOM) and Global Trial Budget Manager (GTBM).
4. In collaboration with the GTL prepare training materials and presentations related to the planning and conduct of the trial.
5. Responsible for the management of the trial master file under the guidance of the GTL.
6. Responsible for managing interactions with the CPOs and/or the CTT under the guidance of the GTL.
7. Support management of trial allocation and feasibility under the guidance of the GTL.
8. Responsible for the coordination of activities leading to site initiations, (including FPP, RIS, etc.).
9. Assist in the oversight of the data review process.
10. Support in trial close out activities including end of trial checklist, operational support of the CSR appendices and trial registries, etc.).
11. Could deputize for the GTL at the CTT meetings.
12. Organize and chair trial sub-teams within the scope of his/her delegated responsibilities.
13. Responsible for implementation of best practices within Global Clinical Operations and could serve as a subject matter expert (SME)
14. May 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 > 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.
• Basic knowledge of Project Management
• 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 years
Qualification: Degree in life science
Industry Type: Pharma/ Healthcare/ Clinical research
Location: Hyderabad
Functional Area: Sales
Job ID: 196726BR
Last Date: 15th October, 2016
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