Join Amgen as a Manager – Centralized Study Support (CSS) in Hyderabad!
Summary:
Amgen is seeking a highly motivated and experienced Manager – Centralized Study Support (CSS) to join our dynamic clinical operations team in Hyderabad, India. This pivotal role offers an exciting opportunity to lead and develop a team of Study Delivery Associates, contribute to the successful execution of global clinical programs, and drive process excellence within a world-class R&D environment. If you are a strong leader with a background in clinical research, clinical operations, and team management, we encourage you to apply!
About Amgen:
Amgen is one of the world’s leading biotechnology companies, committed to unlocking the potential of biology for patients suffering from serious illnesses. With a presence in over 75 countries, Amgen is dedicated to the discovery, development, manufacture, and delivery of innovative human therapeutics.
Job Description:
As a Manager – Centralized Study Support (CSS) at Amgen, you will play a critical role in leading and developing a high-performing team responsible for providing essential support to our global clinical studies. You will be responsible for ensuring the efficient and effective execution of clinical programs, resource allocation, capability development, and continuous improvement initiatives.
Key Responsibilities:
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Team Management:
- Hire, onboard, mentor, and develop Study Delivery Associates & Sr. Associates, fostering a culture of growth and excellence.
- Provide continuous coaching, competency development, and performance management to ensure team members reach their full potential.
- Cultivate a collaborative, accountable, and transparent work environment.
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Resource Allocation & Program Engagement:
- Strategically allocate team members based on their skills, capacity, and the specific needs of each clinical program.
- Ensure team members are adequately prepared and trained for their assigned clinical programs.
- Proactively identify and manage any capacity or skill gaps within the team.
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Capability Development & Continuous Improvement:
- Identify areas for improvement in processes, skills, and tools, and actively drive initiatives to address these gaps.
- Support knowledge-sharing and the adoption of best practices across the team.
- Encourage innovation in clinical study support functions to enhance efficiency and effectiveness.
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Stakeholder Collaboration:
- Serve as the primary escalation point for performance-related issues.
- Build strong, collaborative relationships with cross-functional teams involved in clinical study execution.
- Align resource planning with the overall needs of the global clinical business.
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Quality, Compliance & Audit Readiness:
- Ensure that all activities are conducted in strict accordance with Standard Operating Procedures (SOPs), regulatory guidelines, and Good Clinical Practice (GCP) standards.
- Support internal audit readiness, Corrective and Preventative Action (CAPA) management, and inspection support activities.
- Track quality metrics, identify potential risks, and escalate concerns appropriately.
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Resource Management Support:
- Assist the Study Delivery Resource Management (SDRM) team with hiring, forecasting, and resource allocation efforts.
- Support strategic workforce planning initiatives to ensure the team is adequately staffed and skilled to meet future needs.
Required Qualifications:
- Master’s degree plus 2 years of clinical execution experience, OR
- Bachelor’s degree plus 4 years of clinical execution experience, OR
- Equivalent experience based on Associate’s degree / High school diploma
Preferred Qualifications:
- 5+ years’ experience in clinical research within the biotechnology or pharmaceutical industry.
- Experience managing cross-functional clinical operations teams.
- A strong understanding of clinical trial execution, GCP, Risk-Based Monitoring (RBM), and CAPA principles.
- Proven ability to effectively manage global stakeholders across multiple time zones.
- Experience overseeing study budgets and resource allocation.
Why Join Amgen?
- Be a part of a global biotech leader: Contribute to groundbreaking research and development that impacts patients worldwide.
- Enjoy stable, long-term career growth: Advance your career in clinical operations management with ample opportunities for professional development.
- Gain exposure to advanced technologies and global research programs: Work with cutting-edge tools and contribute to innovative clinical trials.
- Thrive in an inclusive, diverse, and people-centric culture: Join a supportive and collaborative environment that values diversity and fosters employee well-being.
How to Apply:
If you are a highly motivated and experienced professional seeking a challenging and rewarding career opportunity, we encourage you to apply! We look forward to reviewing your application.