Study Delivery Sr Associate Job at Amgen (Hyderabad)

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Study Delivery Sr Associate

The Study Delivery Senior Associate provides essential global study management s...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master's degree OR Bachelor's degree and 2 years of clinical execution experience OR Associate's degree and 6 years of clinical execution experience OR High school diploma / GED and 8 years of clinical execution experience
3 years' work experience in life sciences or medically related field, including 1 year of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience working on global clinical trials
Strong collaborative and effective communication skills within a team environment
Understands importance of accuracy in documentation, data tracking, and compliance checks
Identifies discrepancies and escalates appropriately
Expertise in clinical trial processes, operations, and oversight in biotech, pharmaceutical, or Contract Research Organization environments
Strong skills in using MS Word, Excel, PowerPoint, and other relevant software for documentation, data management, and trial support
Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools
Ability to maintain accurate and timely data entry

Job Responsibility

Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools (e.g., vendor management, sample tracking, drug supply planning) to ensure accuracy and visibility
Coordinate logistics for investigator meetings, trial events, and site communications
Manage assigned start-up activities, including system setup, access management, and document readiness, ensuring completion to required standards
Use study dashboards and reports to monitor global enrollment, data flow, and quality indicators, taking proactive action to address deviations and risks
Lead delivery of assigned risk and quality management activities
Track and report study progress, coordinating with Study team and vendors to resolve operational issues and maintain compliance
Deliver assigned components of global recruitment and retention strategies to help ensure enrollment targets are achieved
Manage Study Training system activities and oversight
Build and maintain effective relationships with internal study team members, vendors and investigator sites
Act as a point of contact for routine study updates, ensuring stakeholders are informed and aligned

Study Delivery Sr Associate

The Study Delivery Associate provides essential administrative and operational s...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's degree OR Associate's degree and 4 years of clinical execution experience OR High school diploma / GED and 6 years of clinical execution experience

Job Responsibility

Support the setup and maintenance of study-level trackers, dashboards and timelines
Communicate study progress, timelines and deliverables to the Study Delivery Manager
Assist with tracking and following up on study actions, including risk mitigation actions
Assist with the preparation and record keeping of risk & quality reviews
Ensure completion of study team training and inspection readiness activities to maintain compliance with regulatory requirements
Assist with trial-related events, global site communications, and logistics for investigator meetings
Support study start-up activities, including system setup, supplier access management, ICF tracking and document readiness
Support vendor relationships and site engagement strategies
Manage shipment, reconciliation and analysis of biological samples
Coordinate investigational product logistics, ensuring compliance with reconciliation processes

Fulltime

Study Delivery Sr Associate

The Study Delivery Associate provides essential administrative and operational s...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's degree OR Associate's degree and 4 years of clinical execution experience OR High school diploma / GED and 6 years of clinical execution experience

Job Responsibility

Support the setup and maintenance of study-level trackers, dashboards and timelines
Communicate study progress, timelines and deliverables to the Study Delivery Manager
Assist with tracking and following up on study actions, including risk mitigation actions
Assist with the preparation and record keeping of risk & quality reviews
Ensure completion of study team training and inspection readiness activities to maintain compliance with regulatory requirements
Assist with trial-related events, global site communications, and logistics for investigator meetings
Support study start-up activities, including system setup, supplier access management, ICF tracking and document readiness
Support vendor relationships and site engagement strategies
Manage shipment, reconciliation and analysis of biological samples
Coordinate investigational product logistics, ensuring compliance with reconciliation processes

Fulltime

Data Management Sr Associate

At Amgen, if you feel like you're part of something bigger, it's because you are...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master's degree
Bachelor's degree and 2 years of clinical execution experience
Associate's degree and 6 years of clinical execution experience
High school diploma / GED and 8 years of clinical execution experience

Job Responsibility

Execute study data management tasks including database build testing, data cleaning, query management, reconciliation, and lock preparation with limited oversight
Support core Data Management roles, such as Data Delivery Leads, Database Designers, and Data Acquisition Leads by owning time-sensitive deliverables with high-quality execution
Actively contribute to setup and maintenance of EDC/non CRF data structures including local labs, coding dictionaries, along with non-CRF data integrations
Track progress against data management timelines, study timelines and deliverables, identify risks or delays, and escalate issues with clear documentation and any mitigations
Coordinate with local internal teams, global team members as well as external partners (including FSPs) when required to ensure aligned and efficient delivery of all study activities
Identify opportunities to improve repeatable processes and contribute to best practices and knowledge sharing across the team

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Sr. Associate Customer Experience & Engagement – GCX Order-to-Cash (GCX-OTC)

The Customer Experience & Engagement Sr. Associate is a customer-facing role res...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

5–8 years of experience in customer service, order management, order-to-cash, supply chain, or contact center operations
Experience in B2B and/or B2C environments preferred
Exposure to GxP-regulated environments (GMP, GCP, GDP) is a plus
Familiarity with SAP, Salesforce, and related digital platforms preferred
Bachelor’s degree preferred (or equivalent professional experience)
Experience working with global teams or U.S.-based companies is an advantage
Excellent verbal communication skills with a professional and confident phone presence
Strong written communication skills
Proficiency in CRM and case management tools (e.g., Salesforce Service Cloud)
Working knowledge of ERP systems such as SAP preferred

Job Responsibility

Serve as a primary point of contact for customers via inbound and outbound phone calls, email, portals, and digital platforms
Manage a high volume of customer interactions while maintaining quality, accuracy, professionalism, and adherence to SLAs
Demonstrate active listening, empathy, and strong communication skills to resolve inquiries effectively
De-escalate challenging conversations and escalate complex or sensitive issues per defined protocols
Deliver consistent, positive, and compliant customer experiences across all touchpoints
Provide proactive updates to customers regarding order status, delays, and resolution progress
Process and manage customer orders accurately in SAP or relevant ERP systems
Support end-to-end OTC workflows including order processing and validation, order status inquiries, delivery coordination, billing questions and dispute management, product or distribution complaints (within scope)
Ensure completeness and accuracy of customer, order, and transaction data
Contribute to on-time order fulfillment and cash collection objectives

Sr. Associate Customer Experience

The Customer Experience Sr. Associate, is responsible for delivering high-qualit...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Strong customer-centric mindset with a commitment to service excellence
Effective written and verbal communication skills
Problem-solving ability with attention to detail and accuracy
Ability to follow standardized processes while exercising sound judgment
Comfort working with digital tools and data entry across multiple systems
Ability to manage multiple tasks and prioritize work in a deadline-driven environment
Team-oriented mindset with accountability for individual performance
Openness to feedback, learning, and continuous improvement

Job Responsibility

Serve as a primary point of contact for customers, responding to inquiries via phone, email, portals, and digital channels
Deliver accurate, timely, and professional customer support aligned with global service standards and SLAs
Resolve routine and non-routine customer issues while escalating complex cases per defined procedures
Maintain clear, empathetic, and proactive communication with customers throughout the resolution process
Ensure a consistent, positive customer experience across all interactions and touchpoints
Process customer orders accurately and efficiently in line with established OTC procedures
Manage order status inquiries, delivery coordination, billing questions, disputes, and product or distribution complaints within scope
Ensure completeness and accuracy of customer, order, and transaction data in relevant systems
Support end-to-end OTC workflows, contributing to on-time order fulfillment and cash collection
Support clinical customer service activities, including investigational product order processing and inquiries

Local Study Operations Sr Manager

In this role, you will lead the skill development of Local Study Operations Mana...

Location

Italy , Milan

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 2 years of clinical execution experience OR Master's degree & 6 years of clinical execution experience OR Bachelor's degree & 8 years of clinical execution experience OR Associate's degree & 10 years of clinical execution experience OR High school diploma / GED & 12 years of clinical execution experience
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 of resources

Job Responsibility

Ensure the successful delivery of the study portfolio assigned to LSOMs
Oversee LSOMs' fulfillment of responsibilities throughout the assigned country portfolio, from feasibility through to study close-out
Monitor portfolio progress, provide risk and quality oversight, and support issue escalation and resolution for LSOMs
Manage LSOM and LSOM vendor performance to guarantee high-quality study execution, serving as the primary escalation point for local study challenges, driving solutions, and ensuring portfolio targets are met within the country
Mentor, train, and support the professional development of LSOMs to prepare them for managing complex trials
Build and maintain a high-performing team
Facilitate close collaboration between the study strategy team and local study teams to effectively manage the assigned portfolio
Promote cross-functional collaboration among country teams to ensure successful delivery of the country portfolio
Support discussions regarding study placement decisions based on country capabilities and growth potential
Proactively evaluate risks, quality trends, and resource requirements

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Sr Mgr Local Study Operations

In this role, you will lead the skill development of Local Study Operations Mana...

Location

Spain , Barcelona

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 2 years of clinical execution experience OR Master's degree & 6 years of clinical execution experience OR Bachelor's degree & 8 years of clinical execution experience OR Associate's degree & 10 years of clinical execution experience OR High school diploma / GED & 12 years of clinical execution experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Ensure the successful delivery of the study portfolio assigned to LSOMs
Oversee LSOMs’ fulfillment of responsibilities throughout the assigned country portfolio, from feasibility through to study close-out
Monitor portfolio progress, provide risk and quality oversight, and support issue escalation and resolution for LSOMs
Manage LSOM and LSOM vendor performance to guarantee high-quality study execution, serving as the primary escalation point for local study challenges, driving solutions, and ensuring portfolio targets are met within the country
Mentor, train, and support the professional development of LSOMs to prepare them for managing complex trials
Build and maintain a high-performing team
Facilitate close collaboration between the study strategy team and local study teams to effectively manage the assigned portfolio
Promote cross-functional collaboration among country teams to ensure successful delivery of the country portfolio
Support discussions regarding study placement decisions based on country capabilities and growth potential
Proactively evaluate risks, quality trends, and resource requirements

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

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Study Delivery Sr Associate

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