Mgr Centralized Study Support

Amgen Inc. (IR); Hyderabad; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Amgen Inc. (IR) Hyderabad, India seeks a Manager, CSS to lead and grow a team of Study Delivery Associates and Sr Associates responsible for high-quality operational support to clinical programs.

You will mentor staff, align allocations with program needs, and drive continuous improvement while ensuring adherence to SOPs and regulatory standards across geographies.

Qualifications

• Doctorate degree OR Master’s degree and 2 years of clinical execution experience OR Bachelor’s degree and 4 years of clinical execution experience OR Associate’s degree and 8 years of clinical execution experience OR High school diploma / GED and 10 years of clinical execution experience.
• 5 years work experience in life sciences industry with focus on clinical trial work, including 3 years at biotech/pharma company.
• Experience managing multiple teams across clinical functions.

Responsibilities

• Recruit, onboard and train new team members to meet program needs.
• Mentor, coach and develop direct reports; manage performance issues with compassion.
• Collaborate with Resource Points of Contact for optimal assignment of team members.
• Ensure team readiness for roles within each assigned program.
• Support development of oversight metrics and address risks & issues.

Skills

Team leadership

Mentoring

Regulatory compliance

Stakeholder management

Clinical trial operations

Resource management

Education

Doctorate or Master’s in life sciences

Tools

CTMS

SOP adherence

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 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

• 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 2 years of clinical execution experience OR Bachelor’s degree and 4 years of clinical execution experience OR Associate’s degree and 8 years of clinical execution experience OR High school diploma / GED and 10 years 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