Expert Clinicl Manager

Job Title: Expert Clinical Manager 
Duties: 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; implementation of issue resolution plan; preparation of clinical outsourcing specifications.
2. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget.
3. Support the development, management and tracking of trial budget working closely with the TA program operations group.
4. Support CTH in managing interactions with Global Clinical Development Operations and other relevant functions including Drug Supply Management and Novartis local medical organizations.
5. Accountable for accuracy of trial information in all trial databases and tracking systems.
6. Contribute to the ongoing scientific review of the clinical data and support trial data analysis, reporting and publishing.
7. May participate in the organization and logistics of various oversight or Advisory Boards.
8. Point of contact for managing/answering questions related to trial procedures and patients’ eligibility.
9. Draft CTT meeting minutes. Participate in International Clinical Team meetings.
10. May organize and chair trial sub-teams within the scope of his/her delegated responsibilities.
11. Assist with 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).
12. Responsible for implementation of best practices and standards for trial management within the TA, including sharing lessons learned.

 
Skills: Languages:
Fluent English (oral and written)
Experience:
• Involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in supporting trial planning, executing, reporting and publishing 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.
Position Requirements: Assists clinical trial leader or may act as clinical trial leader in the management of individual clinical trials. Under the direction of the clinical trial leader or clinical research manager, conducts day-to-day activities including protocol writing, trial administration, report writing and interaction s with other line units in support of clinical trials. Contributes to continuous improvement of process, COntributes in preparing clinical trial protocol summaries and clinical trial protocols. Contributes in preparation and implementation of project specific training programs and training materials for internal and external staff. Contributes in monitoring safety, eligibility, enrollment and data consistency. Contributes in preparing draft clinical trial reports and draft summaries. 1-3 Years Experience.
 
Education: 

• Advanced degree or equivalent education/degree in life science/healthcare required if no previous experience in clinical research. or • Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with ≥ 2 years experience in clinical research.

Thanks and Regards,
Satish
732-312-5510