Manager Centralized Study Support

Amgen Inc. (IR); Hyderabad; On-site; INR 2,000,000 - 3,500,000; Full time

Job summary

Amgen Inc. (IR) is seeking a Manager, CSS to lead a team of Study Delivery Associates and Sr Associates, driving people development and resource planning across clinical programs.

The role emphasizes mentoring, performance management, and proactive risk handling to deliver high-quality operational support. The incumbent will collaborate with cross-functional teams, oversee capacity planning, and ensure compliance with regulatory standards, audits, and CAPA processes, enabling successful study

Qualifications

• Doctorate or Master’s with 8 years clinical execution OR Bachelor’s with 10 years clinical execution.
• Experience managing multiple teams/direct reports across clinical functions.
• Ability to manage budgets and financial operations for trial programs.

Responsibilities

• Recruit, onboard and train new team members.
• Provide mentoring and competency development for all reports.
• Manage performance issues and ensure team culture of collaboration.
• Collaborate with Resource Points of Contact for optimal staffing.
• Ensure adherence to SOPs, regulatory guidelines and quality standards.

Skills

People management

Resource allocation

Program management

Cross-functional collaboration

Clinical trial experience

Education

Doctorate degree

Master’s degree with 8+ years clinical execution

Bachelor’s degree with 10+ years clinical execution

Job description

Career Category Clinical Development Job Description This position requires People Management experience, Resource Allocation/Planning/Management experience

ABOUT THE ROLE

Role Description: The Manager, CSS is accountable for hiring, managing, mentoring and growing a team of Study Delivery Associates and Sr Associates. The role is accountable for continually developing the CSS roles within their team, ensuring they are positioned to deliver high-quality operational support to clinical programs and managing performance issues effectively and compassionately.

Roles & Responsibilities:

Team Management

• Recruit, onboard and train (in partnership with R&D Training) new team members to meet current and future program needs
• Provide regular mentoring, coaching and competency development support for all direct reports
• Proactively manage team risks, including attrition and performance challenges.
• Foster a positive team culture, focused on collaboration, open communication, accountability and continuous growth.
• Organize and lead continuous development training sessions where appropriate

Resource Allocation & Program Engagement

• Collaborate with Resource Points of Contact to ensure optimal assignment of team members based on skills, experience, and workload.
• Monitor resourcing needs and proactively address capacity or skill gaps.
• Ensure team members are appropriately prepared for their roles within each assigned program.

Capability Development & Continuous Improvement

• Identify gaps in skills, processes, or tools and implement targeted development or training initiatives.
• Support knowledge sharing across the team to build collective expertise.
• Encourage innovative solutions and best practice adoption to enhance operational effectiveness.

Stakeholder Collaboration

• Serve as the main point of contact for performance escalations related to CSS team members
• Build strong relationships with internal stakeholders to align team development & allocation with the broader needs of the business

Quality & Compliance

• Support the development of team oversight metrics and regularly report progress towards them / swiftly address risks & issues.
• Ensure all team members operate within SOPs, regulatory guidelines and quality standards.
• Support audit & inspection readiness.

Resource Management Support

• Support Provide support to the SDRM Resource Management team as needed.
• Support may include management of hiring, allocations and forecasting analysis for in scope roles.

Basic Qualifications and Experience

• Doctorate degree OR Master’s degree and 8 years of clinical execution experience OR Bachelor’s degree and 10 years of clinical execution experience of clinical execution experience

Preferred Qualifications and Experience

• 5 years work experience in life sciences industry, particularly focusing on clinical trial work, including 3 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 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
• Strong collaboration and communication skills to engage with cross-functional teams, senior management and external stakeholders, internally and externally
• Strong understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles
• Navigates diverse regulatory, cultural, and operational environments.
• Builds strong relationships across geographies and time zones.
• Ability to identify operational risks based on protocol design and implement innovative mitigation strategies.
• Identify and manage study issues, communicating and/or escalating appropriately.
• Able to identify and implement opportunities for continuous improvement into the team’s working practices
• Clear understanding of risk-based site monitoring ensuring regulatory compliance and timely implementation of Corrective and Preventive Actions (CAPA) to mitigate risks, resolve operational challenges and ensure inspection readiness
• 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

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. . 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. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen