Sr Manager Centralized Study Support (CSS)

1074 Amgen Technology Pvt Ltd.; Hyderabad; On-site; INR 3,000,000 - 5,000,000; Full time

Job summary

Amgen Inc. seeks a Sr Manager, CSS to lead Centralized Study Support teams and drive high-quality operational support across clinical programs. The role ensures strategic alignment of resources with priorities, coaching managers, and maintaining regulatory compliance.

Responsibilities include resource planning, stakeholder collaboration, and continuous improvement initiatives, including technology-enabled solutions. Strong leadership and extensive clinical execution experience are required.

Qualifications

• Minimum of 2 years of people leadership experience across teams, projects or programs.
• Extensive experience in clinical operations or centralized study support.
• Strong knowledge of SOPs, regulatory guidelines and quality standards.

Responsibilities

• Provide leadership, direction and mentorship to multiple Managers, Centralized Study Support. Align goals with corporate priorities and ensure KPI performance.
• Coach and mentor managers to enhance leadership, performance management and team building capabilities.
• Oversee resource allocation and proactive mitigation plans; partner with Talent Acquisition for hiring and succession planning.
• Build trust-based relationships with stakeholders and escalate issues to senior leadership; communicate updates clearly.
• Identify skill gaps and develop a cohesive capability-building strategy; leverage AI and automation where appropriate.
• Support SDRM with hiring, allocations and forecasting analysis for in-scope roles.

Skills

Leadership

People Management

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

Job description

Career Category Clinical Job Description

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting‑edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description: The Sr Manager, CSS is responsible for strategic and operational leadership of multiple Managers within Centralized Study Support (CSS). This role ensures delivery of high‑quality centralized operational support across clinical programs and alignment of resources with organizational priorities.

Roles & Responsibilities

• Team Management Provide leadership, direction and mentorship to multiple Managers, Centralized Study Support. Set strategic goals for the team in collaboration with Sr Mgr colleagues and in alignment with corporate objectives Ensure consistency in management practices, performance standards and staff development approaches across all managers. Monitor functional performance against KPIs, addressing challenges and capitalizing on opportunities for improvement.
• Manager Development & Support Coach and mentor managers to enhance their leadership, performance management & team building capabilities. Support managers in addressing complex performance or resourcing challenges. Promote a culture of accountability, transparency, quality and continuous learning across all levels.
• Resource Planning & Program Engagement Oversee resource allocation across Managers’ teams ensuring optimal alignment with program requirements. Anticipate resourcing risks and pro‑actively develop & execute effective mitigation plans. Anticipate resourcing needs and partner with Talent Acquisition for timely hiring and succession planning.
• Stakeholder Collaboration & Communication Build strong trust‑based relationships with key stakeholders and act as the senior operational contact for escalations involving centralized study support teams, Communicate succinct, effective functional updates, priorities, risks and successes to Director, SDRM Quality & Compliance Ensure all team members operate within SOPs, regulatory guidelines and quality standards.
• Capability Building & Continuous Improvement Identify organizational skill gaps and develop a cohesive capability building strategy in partnership with Sr Mgr, CSS colleagues. Lead initiatives to enhance processes, tools and systems that improve the quality, efficiency and consistency of CSS (pro‑actively leveraging AI and other automation opportunities where appropriate).
• Resource Management Support Provide support to the SDRM team as needed. Support may include management of hiring, allocations and forecasting analysis for in scope roles.

Basic Qualifications and Experience

• Doctorate degree and 2 years of clinical execution experience OR Master’s degree and 6 years of clinical execution experience OR Bachelor’s degree and 8 years of clinical execution experience OR Associate’s degree and 10 years of clinical execution experience OR In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications and Experience

• 12+ years work experience in life sciences industry, particularly focusing on clinical trial work, including 5 years of biopharmaceutical clinical research experience obtained at a biotech or pharmaceutical company
• Experience managing multiple teams / direct reports across multiple clinical functions

Competencies

• Ability to identify operational risks based on protocol design and implement innovative mitigation strategies. Identify and manage study issues, communicating and/or escalating appropriately.
• Strong collaboration and communication skills to engage with cross‑functional teams, senior management and external stakeholders, internally and externally.
• Interprets clinical and operational data to guide trial execution and identify study trends. Collaborates with biostatistics and data management to ensure data integrity.
• Ability to manage, mentor, and develop professionals and support staff across functions & geographies, while fostering collaboration across internal and external teams for trial success.
• Experience with overseeing study budgets and financial operations, reviewing/approving site expenditures, and optimizing resource allocation to ensure cost efficiencies.
• Able to identify and implement opportunities for continuous improvement into the team’s working practices.
• Strong understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles.
• Experience with overseeing external vendors (Contract Research Organizations, labs, imaging vendors, etc.) to drive and meet study deliverables with high quality.
• Navigates diverse regulatory, cultural, and operational environments.
• Builds strong relationships across geographies and time zones.
• Experience with developing and training teams related to clinical trial materials (e.eg., CRAs, site staff, and cross‑functional teams) to ensure alignment with study protocols, regulatory requirements, and best practices.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen