Study Delivery Associate Job at Amgen (Hyderabad)

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, including 1 years 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 for documentation, data management, and trial support
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
Ability to maintain accurate and timely data entry

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 to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

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
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
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

What we offer

Reasonable accommodation for individuals with disabilities

New

Local Study Operations Manager

Location

Türkiye , Istanbul

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience
Advanced knowledge of global clinical trial management
BA/BS/BSc
Minimum 2-3 years’ experience of leading local/regional or global teams
Minimum 2-3 years’ clinical trial project management experience
7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
Must be a local/country expert with proven project management experience locally
Must be able to build strong site relationships as well as other local relationships to ensure end to end study delivery is met

Job Responsibility

Partner with global and local country teams to provide high level country strategy and actively drive study progress and local/country level study delivery
Responsible for compiling and submitting submissions to ethics committees/councils within the country/ies as well as submissions relating to other aspects country needs such as, European Union Clinical Trials Regulation (EU CTR), In Vitro Diagnostic Medical Devices Regulation (IVDR) directives etc.
Accountable for study results and drives key decisions within country
Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study Team (LST)
Contribute and develop program/study-specific materials – e.g., monitoring plan, study specific training documents
Support and contribute to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs) as applicable, agenda driven, present at meetings when needed
Communicate country status (including timelines and deliverables) to key partners including updates to relevant systems for transparency
Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country(ies)
Manage, oversee and supervise applicable vendor activities e.g., laboratories and equipment provisioning
Utilize local/country regulatory knowledge to contribute to NAMP provisioning and import/export license processes

Fulltime

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.

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

Study Delivery Associate

Amgen

Location:
India , Hyderabad

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 15, 2026

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