SDC Clinical (India) Private Limited is Hiring Clinical Data Management

Responsibilities :

1. Oversees day-to-day data management operations
2. Serves as subject matter expert during client and vendor meetings
3. Actively supports business development in capabilities presentations to prospective and current clients
4. Effectively provides input for department and clinical study budgets
5. Liaises with internal and external cross-functional teams, sponsors, vendors, etc.
6. Serves as Project Manager on clinical studies, as needed
7. Works closely with Director of Data Management, Clinical Data Managers and Clinical Data Analyst to mentor data management staff
8. Ensures project work is planned, resource allocated and is successfully executed
9. Provides direction to staff when issues arise that the staff cannot resolve on their own
10. Ensures proper training and development of staff
11. Conducts regular meetings and completes year-end performance reviews with all direct reports
12. Monitors performance of team and initiates process and resource improvement in partnership with Director of Data Management
13. Adheres to all aspects of the company’s quality system
14. Complies with the company’s data integrity and business ethics requirements
15. Performs other related duties incidental to the work described herein
16. Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

Requirements :

1.  Master’s degree (preferably in Engineering, Applied or Life Science) and at least five (5) years of experience in Clinical Data Management including leading several clinical studies, or a Bachelor’s degree (preferably in Engineering, Applied or Life Science) or equivalent education and work experience with a minimum of six (6) years of experience in clinical trials, or current Certified Clinical Data Manager (CCDM) status and six (6) years of experience in clinical trial.
2. Articulate and professional
3. Extensive experience in Clinical research and Data Management in multiple therapeutic areas
4. Electronic Data Capturing (EDC) experience; experience utilizing Medidata Rave a strong plus
5. Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of
6. Federal Regulations
7. Strong project management abilities including analytical evaluation, organization, delegation, flexible team
8. Management, negotiating and resource management skills
9. Effective leadership, budget forecast and implementation skills
10. May Require Travel up to 20%