Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Study Start-Up Leader
Job ID R0000031382 Bengaluru, Karnataka, IndiaJob Purpose: The Associate Study Start-up Leader/ Study Start-Up Leader is accountable for the execution of the study start-up strategy and planning, including the management and coordination of start-up activities such as alignment to country regulations, Core/Site document collection/ approval, ICF customization/approval, EC and RA/ MoH submissions, SIV scheduling and activation requirements.
The Senior Study Start-Up Leader, is accountable as noted above including:
1. Acting as study-level program lead, such as managing multiple protocol delivery for a Sponsor or asset development.
2. Acting as an Enterprise or Biotech level lead and provide expert level knowledge on agreed partnership process.
3. Additional responsibilities may include:
- Study Start-Up Leader mentorship
- Participation in training and support programs
- Fulfilling subject matter expert or process improvement roles within Clinical Operations
Key Accountabilities:
- Manage the study start up process, through development of a site activation strategy and to oversee start-up delivery and governance.
- Coordinate, develop and articulate the critical path planning, and implement as part of the Site Initiation Scheduling, System Set-up, EDL Management, EC & RA/ MoH Strategy, ICF Customization, Risk Mitigations, Monitoring Plan, Site Activation Requirements & Relevant Tools.
Knowledge and Experience:
- Proven client-facing relevant experience in healthcare, clinical research, project management or contract research organization
- Experience in a multi-national organization
- Prior Project Management experience preferable
- End to End study start-up experience & expertise preferred
- Competent in written and oral English
Education:
- Degree in a life science or relevant clinical trial experience, especially in study start up activities
- Advanced degree preferable
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