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 RD 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 creative 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

- 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

- Masters degree and 8 years of clinical execution experience OR

- Bachelors 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 teams 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

📌 Manager, Centralized Study Support (Hyderabad)
🏢 Amgen
📍 Hyderabad