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Manager, Centralized Study Support

Amgen
Amgen
8-10 years
Not Disclosed
10 Dec. 30, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Manager, Centralized Study Support (CSS)
Location: Hyderabad, India
Company: Amgen
Employment Type: Full-Time
Experience Required: 8–10 years in clinical execution with people management experience


About the Role

Amgen is seeking a Manager for Centralized Study Support (CSS) to lead a high-performing team responsible for delivering operational support across clinical programs. This role focuses on people management, resource allocation, team development, and ensuring high-quality clinical operations. The Manager will oversee Study Delivery Associates and Senior Associates, fostering a culture of collaboration, accountability, and continuous growth.

This position requires hands-on experience in resource planning, people management, and clinical operations within the life sciences or pharmaceutical industry.


Key Responsibilities

Team Leadership & People Management

  • Recruit, onboard, and train new team members in partnership with R&D Training.

  • Mentor, coach, and support competency development for all direct reports.

  • Proactively manage team risks including attrition and performance challenges.

  • Foster a positive and collaborative team culture.

  • Organize and lead continuous development training sessions as required.

Resource Allocation & Program Engagement

  • Collaborate with Resource Points of Contact to ensure optimal assignment of team members based on skills, experience, and workload.

  • Monitor team capacity and address skill gaps proactively.

  • Ensure team members are fully prepared for their roles in assigned programs.

Capability Development & Continuous Improvement

  • Identify gaps in skills, processes, or tools, and implement targeted development or training initiatives.

  • Support knowledge sharing and adoption of best practices to enhance operational effectiveness.

  • Encourage innovative solutions for process improvement.

Stakeholder Collaboration

  • Serve as the primary point of contact for performance escalations related to CSS team members.

  • Build strong relationships with internal stakeholders to align team development and resource allocation with business needs.

Quality, Compliance & Risk Management

  • Ensure team members operate within SOPs, regulatory guidelines, and quality standards.

  • Support audit and inspection readiness.

  • Implement risk-based site monitoring, CAPA plans, and operational risk mitigation strategies.

Resource Management Support

  • Collaborate with the SDRM Resource Management team on hiring, allocations, and forecasting for CSS roles.

  • Oversee study budgets, review/approve site expenditures, and optimize resource allocation for cost efficiency.


Required Qualifications

  • Doctorate degree, OR

  • Master’s degree with 8 years of clinical execution experience, OR

  • Bachelor’s degree with 10 years of clinical execution experience.

  • Proven people management experience with direct reports across multiple clinical functions.

  • Strong understanding of clinical trial execution, drug development processes, and regulatory compliance.


Preferred Qualifications

  • 5+ years of experience in the life sciences industry, particularly biopharmaceutical clinical research.

  • Experience managing multiple teams across geographies.

  • Strong collaboration and communication skills with cross-functional teams, senior management, and external stakeholders.

  • Experience in developing and training teams on clinical trial materials, protocols, and regulatory requirements.

  • Familiarity with resource allocation, study budgeting, and financial operations.

  • Ability to identify operational risks, implement mitigation strategies, and drive continuous improvement.


Why Join Amgen

  • Lead a high-impact clinical operations team supporting global programs.

  • Work in a collaborative, innovative, and growth-oriented environment.

  • Competitive total rewards package, including health, financial, and retirement benefits.

  • Flexible work arrangements to support work-life balance.

  • Career development opportunities including mentorship, training, and leadership growth.


Equal Opportunity Statement:
Amgen is an Equal Opportunity Employer and considers applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability. Reasonable accommodations are provided for individuals with disabilities to perform essential job functions.

Apply Now to advance your career as Manager, Centralized Study Support and contribute to operational excellence in clinical trials at Amgen.