How to Apply:
Please email your resume and cover letter to careers@oneworldhealth.org or mail to:
Institute for OneWorld Health
c/o Human Resources
50 California Street, Suite 500
San Francisco, CA 94111
Due to the volume of inquiries, we are unable to respond to phone calls. We will acknowledge receipt of your resume via email, and will contact you if you are a potential candidate for the position.
Thank you for your interest in OneWorld Health.
OneWorld Health is proud to be an equal opportunity employer committed to providing a diverse workplace.
|
|
Employment
Department: Clinical Job Title: Director, Clinical Operations: Phase I to IV Job Location: International Description:
Location: New Delhi
PROJECT SUMMARY
The Director of Clinical Operations Phase I to IV is responsible for developing the Clinical operations in India and managing Clinical Operations staff, Project Managers, Monitoring Services and Client Services. S/he will collaborate with both Local and Global employees and Heads of Organization. S/he will also liaise with Technical departments and with support functions such as Human Resources, Finance, Administration and Regulatory as required. The Director coordinates with external medical and professional bodies and is overall responsible for Clinical Operations budgets and staffing.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
- Experience Running Multiple Clinical Trials is required
- Develops the Clinical operations organization in India
- Manages the conduct of Organization sponsored Phase I-IV clinical research programs, with appropriate use of internal or external resources
- Manages the Clinical Operations group, ensuring that staff are appropriately qualified and trained for the roles they are undertaking
- Provides oversight of Vendors to ensure operation occurs to the required standards and budgets
- Drives ongoing improvements in key performance metrics and quality management
- Oversees and is responsible for agreed aspects of trials that are outsourced (globally or locally)
- Reviews protocols, CRFs, and scientific documents for appropriate feasibility evaluation and feedback to Clinical Study Operations and the Business Units. Responsibilities include timely responses to Program, Protocol and Site Level feasibility
- Partners with and develops strong links with key sites within the country so that these can be used to support clinical trials
- Provides periodic reporting on clinical research activity and key metrics to Regional Director
- Supports the preparation, filing, and prosecution of CTA’s to initiate clinical trials, where appropriate
- Supports the development, adoption, and implementation of processes and systems necessary for the effective conduct of clinical research
- Responsibility for clinical supplies management
- Drives compliance by partnering with quality and compliance groups
- Partners with Development Operations colleagues and local Business Units in the selection and placement of clinical research studies
- Works intimately with business development on bid generation and bid defense
- Monitors and communicates any current and potential changes in local regulations related to the conduct of clinical research and to the local pharmaceutical industry in general, being a source of expert knowledge regarding the designated country in terms of regulatory, legal, ethical, and clinical practice considerations
- Maintains and communicates knowledge on country capability, capacity, and clinical research environment to Clinical Study Operations and local Medical Affairs
- Ensures effective organization and deployment of clinical operations resources including the planning and prioritization of future resource requirements
- Forecasts and properly executes clinical operations budget to minimize costs
- Responsible for ensuring the performance management of all clinical operations staff including goal setting, performance reviews, career guidance, and developmental opportunities
- Actively creates an environment of openness, innovation, and inclusiveness that promotes effective change and a philosophy of Continuous Improvement
- Maintains effective relationships with other platform lines, Business Units, and enabling lines that would facilitate more effective portfolio delivery.
Job Requirements:
ESSENTIAL QUALIFICATIONS
- Masters Degree, preferably in Biomedical Sciences; MSc, PhD/ PharmD, or MD preferred
- Minimum of 7-13 years of experience in Heading Healthcare, Medical, R&D Department of a Pharmacy / Biotech / Clinical Research Industry
- Minimum of 3-5 years experience in resource forecasting and budget management
- Solid understanding and application of performance and productivity metrics
- Exceptional people skills and the ability to work in a team environment
- Strong written and verbal communication skills
- Excellent Leadership, Project Management and Resource Management skills, particularly in handling staff and financial matters
- Strong skills with Coaching, Change Management, Administrative, and Technical Capabilities
- Ability to adapt to Multi-Cultural work environment
- Significant experience in Operational aspects of Clinical Drug Development
- Experience in Vendor Management
- Independent judgment and decision-making skills with respect to functional responsibilities
- Fluency in English language
How to Apply
Please send us the application before closing hours of December 05, 2009 to indiacareers@oneworldhealth.org. No application beyond the stated date shall be entertained.
Only candidates who are under serious consideration will be contacted. Submit your resume online now
|
