Study Delivery Associate Job at Amgen (Hyderabad)

Global Study Manager

This role within GCSD plays a pivotal part in driving the clinical operations of...

Location

United Kingdom; Italy , London; Siena

Salary:

Not provided

GSK

Expiration Date

April 07, 2026

Requirements

Bachelor’s degree: life sciences or related discipline
Good understanding of complex clinical development and regulatory processes
In-depth experience in clinical research: study management, monitoring, data management
Strong skills and experience in project management and tools
Strong performer / executor of operational tasks with strong skills and experience in study delivery
Experience of working across multiple types of study designs
In depth knowledge of GCPs and ICH guidelines
Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills
Demonstrates leadership skills, promoting motivation and empowerment of others
Strong understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs

Job Responsibility

Be the Working Group (WG) Lead for Clinical Operations with accountability for the operational delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements
Be accountable for the following deliverables: Study Initiation Meeting, Clinical Study Activity Plan, Study Delivery Plan, TMF Quality Strategy Document, DCT Set Up, Study Demographic and Diversity Plan, Vendors Oversight Plan, Results Dissemination Plan, Investigator/CRA Meeting Set Up & associated training, Expected Document List, Recruitment Tracking, Budget tracking eTMF filing and Vendor Set Up and Management, Patient Engagement Activities, CSDD KOM & template, Safety Management plan, Protocol Deviation Management Plan, eTMF & vendor set-up, Pharmacy Manual
Support assessment and selection of FSO vendors
Be accountable for holistic oversight of FSO vendors according to the FSO handbook
Be responsible for assessment and selection of other study vendors under GCSD responsibility in consultation with GSL
Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for assigned studies
Balance risk/benefit to make decisions based on clear understanding of impact on the study and project
Proactively and effectively identify, oversee, and mitigate study risks
Ensure appropriate stakeholder communication, including study status, expectations, risks and issues
Be accountable to operate within the study budget

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Pension plan membership
Shares and savings programme

Fulltime

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Study Delivery 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
Associate’s degree and 4 years of clinical execution experience
High school diploma / GED and 6 years of clinical execution experience
2 years' work experience in life sciences or medically related field
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
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
Experience with tracking and filing of essential documents such as protocols, informed consent forms, and regulatory submissions
Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools

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

What we offer

Reasonable accommodation for individuals with disabilities

Global Clinical Delivery Manager

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Bulgaria , Sofia

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or related field
advanced degree preferred
Minimum of 5 years of experience in clinical research
1-2 years working as an Associate Project Manager within a CRO or Pharma setting
Vendor management experience
Global experience
Working closely with cross functional teams for status updates and deliverables
Excellent knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards
Well familiar with key systems used in clinical trial delivery
Experience in using Trial Master File industry accepted standard

Job Responsibility

Support the coordination and management of clinical trials globally
Contribute to the design, analysis, and advancement of innovative treatments and therapies
Deliver the clinical study to time, cost and quality
Ensure inspection readiness by taking an oversight over study eTMF completeness
Work on end-to-end operational study delivery activities, from study setup to study archival
Focus on setting up, maintaining and ensuring completeness of internal systems / databases / tracking tools and project plans (CSAP)
Work cross-functionally, with internal and external partners, on clinical study management activities
Monitor study conduct and progress
Identify, resolve and escalate risks/issues which may impact delivery of the study
Review key clinical documents, including the Protocol and Informed Consent Forms

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

Local Study Associate Director

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor degree in related discipline, preferably in life science, or equivalent qualification
Five years of US focused clinical trial management experience, including budget oversight
Good knowledge of international guidelines ICH- GCP as well as relevant local regulations
Excellent project management skill
Excellent team building and interpersonal skills
Excellent organisational skills
Excellent verbal and written communication skills
Excellent ability to prioritize and handle multiple tasks
Excellent attention to details
Excellent knowledge of spoken and written English

Job Responsibility

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality
Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations
Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study
Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head
Ensures timely preparation of local Master CSA (including site budget) and amendments as needed
Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local regulations
Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with SOPs

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

New

Global Study Manager

Global Study Manager – This position is a fully client-embedded role, dedicated ...

Location

Poland

Salary:

Not provided

myGwork - LGBTQ+ Business Community

Expiration Date

Until further notice

Requirements

Bachelor’s degree: life sciences or related discipline
At least 5+ years of relevant study management experience on a global level
In-depth experience in clinical research: study management, monitoring, data management
Must have exposed to clinical study management “end-to-end” Globally : NA, EMEA, APAC, LATAM – China & Japan, Africa is an asset
Must have proven experience from study feasibility to CSR
Must have at least Ph II and PIII experience – PI & PIV is an asset
Must have cross-functional leadership proven experience, able to drive internal and external meeting
Able to input in clinical protocol, ICF, and other study plan, savvy in clinical study risk management and clinical systems
Strong experience in clinical budget management
Strong experience with vendor management including CRO

Job Responsibility

Accountable for delivering the clinical operation activities of the study until study archiving
Generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds and with quality
Accountable for the operational delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, supporting decision -making at pace and leading study team to achieve overall study deliverables
Accountable for the following deliverables: Study Initiation Meeting, Clinical Study Activity Plan, Study Delivery Plan, TMF Quality Strategy Document, DCT Set Up, Vendors Oversight Plan, Investigator/CRA Meeting Set Up & associated training, Recruitment Tracking, Budget tracking eTMF filing and Vendor Set Up and Management, Safety Management plan, eTMF & vendor set -up
Proactively and effectively identifies, oversees, and mitigates study risks
Ensures appropriate stakeholder communication, including study status, expectations, risks and issues
Accountable to operate within the study budget
Effectively leads empowered matrix teams
Responsible for operational input into protocol and informed consent form development, and other key study documents
Leads and conducts investigator meetings and other study related meetings

Fulltime

Global Delivery Manager

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or related field
advanced degree preferred
Minimum of 5 years of experience in clinical research
1-2 years working as an Associate Project Manager within a CRO or Pharma setting
Vendor management experience
Excellent knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards
Well familiar with key systems used in clinical trial delivery
Experience in using Trial Master File industry accepted standard
Strong project management skills (preferably with analytical / financial skills) and good leadership skills
Excellent verbal and written communication in English

Job Responsibility

Support the coordination and management of clinical trials
Contributing to the design, analysis, and advancement of innovative treatments and therapies
Delivering the clinical study to time, cost and quality
Ensuring inspection readiness by taking an oversight over study eTMF completeness
Working on end-to-end operational study delivery activities, from study setup to study archival
Setting up, maintaining and ensuring completeness of internal systems / databases / tracking tools and project plans (CSAP)
Working cross-functionally, with internal and external partners, on clinical study management activities
Monitoring study conduct and progress, identifying, resolving and escalating risks/issues
Reviewing key clinical documents, including the Protocol and Informed Consent Forms
Leading development of study plans (e.g. Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan etc.)

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

Associate Director Global Clinical Program Management

In this vital role you will lead the operational delivery of complex clinical pr...

Location

United States

Salary:

182145.00 - 212860.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of clinical execution experience
Master’s degree and 7 years of clinical execution experience
Bachelor’s degree and 9 years of clinical execution experience
Associate’s degree and 12 years of clinical execution experience
High school diploma / GED and 14 years of clinical execution experience
Minimum of 3 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead the operational planning and delivery of multiple clinical studies or programs, ensuring timelines, budget, quality, and strategy are met
Proactively identify delivery risks and guide course-correction to keep studies on track
Drive consistent, high-quality operational practices across all assigned studies and programs
Line-manage and develop Study Delivery Leads, setting clear objectives and fostering high performance
Oversee program-level issues, risks, and escalation, ensuring timely and effective resolution
Partner cross-functionally and with local execution teams to align priorities, resources, and delivery plans
Provide strategic input on study design, country selection, enrolment, diversity, and patient-centric approaches
Manage program-level budgets, vendors, and forecasting while embedding lessons learned and continuous improvement

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

Global Study Manager

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

University degree / Bachelor’s degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience
Minimum of 3 years clinical trial management experience
Experience of working with and delivering through strategic partners and 3rd party vendors
Experience in phase I oncology
Experience working on a global level
Candidate must reside in US and work Eastern time (Eastern and Central time zone candidates)
Experience in external provider oversight and management

Job Responsibility

Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance
Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents
Manage the set-up of third-party vendors assessing initial statement of work and budget, as well as the change order process
Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data
Initiate contract/budget requests and track ongoing status
facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget
Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate
Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report
Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies
Assist in the clinical trial insurance process

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Study Delivery Associate

Amgen

Location:
India , Hyderabad

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 05, 2026

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