CrawlJobs Logo
Amgen Logo Amgen · -

Clinical Trial Oversight Manager

Italy, Milan · Job Posted February 20, 2026
Apply Position
Job Link Share

Job Description

Do more with the knowledge you’re working hard to acquire and the passion you already have. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide.

Job Responsibility

  • Perform sponsor oversight activities of SM-FSP, including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials
  • Collaborate closely with SM-FSP Line Manager (FSPLM) to ensure appropriate level of their staff oversight is deployed
  • Support SM-FSP staff onboarding and training
  • Be a point of escalation for all stakeholders to support resolution of issues on quality, staff turnover and performance concerns
  • Work with SM-FSP vendor(s) to ensure timely and appropriate planning, resource and capacity management from study start up to close-out
  • Conduct on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships
  • Support inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution
  • Organize and lead the Functional Management Team (FMT) Meetings and any other country-level project review meetings, if applicable
  • Be involved in local and global site management and cross functional stakeholder collaboration
  • Actively participate in role forums including local and global functional and cross-functional initiatives

Requirements

  • Master’s degree OR Doctorate degree OR BA/BS/BSc or qualified nurse (RN)
  • Work experience in life sciences or medically related field, including Biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)
  • Broad work experience working in life sciences or medically related field, including clinical site management experience, obtained working on clinical trials in a biotech, pharmaceutical or CRO company
  • Experience as a CRA, CTA, and/or Clinical/Regional Manager in the biopharmaceutical industry
  • Experience in a project leadership role
  • Experience working with or for Functional Service Provider or Contract Research Organizations
  • Supervisory Experience
  • Knowledge of or work experience with a biopharmaceutical GRDCA or QC department
  • Familiarity with advanced concepts of clinical research, extensive knowledge of ICH/GCP regulations and guidelines, strong knowledge of clinical trial operations, and understanding of Functional Service Provider operational model
  • Computer and system operation skills
  • Relevant therapeutic area education and training
  • Detailed understanding of customer service and demonstrated ability to anticipate and resolve problems
  • Demonstrated ability to work independently with minimal supervision and effectively in a team/matrix environment on multiple projects
  • Excellence in relationship building, ability to lead and influence in a positive manner, and strong leadership skills
  • Strong interpersonal skills, excellent organizational and planning skills, excellent oral and written communication, and business English fluency
  • Attention to quality and detail, ability to identify and resolve problems, and attention to quality planning and execution
  • Ability for critical thinking, thinking out of the box, and flexibility
  • Ability to write and present clearly using scientific and clinical issues terminology

What we offer

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Amgen - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Clinical Trial Oversight Manager

8 matching positions

Country Clinical Trial Manager / Local Trial Manager

Register your interest for future opening with us as a Local/Country Clinical Tr...
Location
Location
Italy
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum of 5 years of relevant end to end clinical trial management experience
  • Experience with customization or localisation of patient facing documents is essential
  • Excellent leadership, communication, and organizational skills. Able to multi-task under limited direction and on own initiative
  • M.S/M.A/Ph.D or B.A/B.S/nursing degree is essential
  • Prior and demonstrable experience working at a senior level within Study start up preferred
Job Responsibility
Job Responsibility
  • Regional/Country/Study level implementation of Start-up and Site Activation Plans
  • Responsible for country/study level Recruitment Strategy
  • Responsible to support the development of study level plans
  • Communication with the local team and internal stakeholders and CRO partner as applicable and as listed above to ensure efficient and timely study delivery of the agreed plans
  • Responsible for study and/or country vendor management and oversight including follow up and coordination of vendor deliverables
  • The Country Study Operational Manager will be able to work independently and exercise their own judgement
Read More
Arrow Right

Senior Manager, Clinical Operations/ Senior Global Trial Manager - FSP

Parexel are currently recruiting for an experienced Global Study Operations Mana...
Location
Location
Italy; United Kingdom , Remote; Remote
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum of 7 years of relevant clinical trial management experience
  • Global trial management experience is essential
  • Experience managing CRO outsourced studies is essential
  • Excellent leadership, communication, and organizational skills
  • Able to multi-task under limited direction and on own initiative
  • M.S/M.A/Ph.D or B.A/B.S/nursing degree is essential
  • Prior and demonstrable experience working at a senior level within Study start up preferred
Job Responsibility
Job Responsibility
  • Accountable for the end-to-end clinical trial delivery
  • Providing operational leadership and oversight of cross-functional deliverables
  • Leading a cross functional trial team to build and deliver the trial operational plan
  • Responsible for leading the Cross functional trial team to influence and execute delivery of the operational plan and for end-to-end trial execution
  • Accountable for overall trial delivery, budget, timelines, quality, and milestones
  • Oversight of all aspects of CRO/vendor identification, set up, statement of work creation, budget oversight and performance (KPI’s and metrics)
  • Proactively ensure that trial deliverables and milestones are met according to corporate and study-level goals
  • Identify risks and ensure mitigations and contingencies are being initiated and followed through
  • Ensure trial Is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes
  • Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits
Read More
Arrow Right

Clinical Trial Manager II

Clinical Trial Manager - early oncology. ICON plc is a world-leading healthcare ...
Location
Location
United States , Atlanta; Charlotte; Burlington; Blue Bell; Tampa; Durham
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BA/BS degree with at least 3 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial management experience
  • Must have strong knowledge of ICH/GCP guidelines and regulatory requirements
  • Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring
  • Requires project management skills and trial leadership ability
  • Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
  • Fluent in English
  • Experience in Phase I oncology
  • Global experience with primary focus on independent vendor set up and management, oncology cohort management and experience in supporting dose escalation safety meetings
  • May be asked to Work East coast hours if located further West
  • Moderate (~25%) travel required
Job Responsibility
Job Responsibility
  • Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
  • Leads or supports cross-functional trial teams, including vendors
  • Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders
  • Proactively identify and resolve issues that arise during trial conduct
  • manage escalation of trial-related issues
  • Participate in or lead the development of core trial documents, trial plans and system set-up
  • participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data
  • Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors
  • effectively manage interactions and escalations with vendor trial team
  • Participate in or lead feasibility assessment and selection of countries and sites for trial conduct
What we offer
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
  • Fulltime
Read More
Arrow Right

Senior Clinical Trial Manager

As a Senior Clinical Trial Manager at ICON, you will manage clinical trial opera...
Location
Location
Australia , Sydney
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A minimum of 6+ years of experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organization (in addition to CRA experience)
  • Bachelor's degree in health, life sciences, or other relevant fields of study
  • At least 10+ years of relevant experience in clinical trial management.
Job Responsibility
Job Responsibility
  • Budget Oversight
  • Ensuring Effective Study Oversight
  • Optimizing Performance
  • Timely Study Start-Up & Enrollment
  • Improving Study Integrity
  • Building Productive Relationships.
What we offer
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.
  • Fulltime
Read More
Arrow Right

Clinical Trial Manager

We are seeking a hands-on Clinical Trial Manager to oversee clinical trial opera...
Location
Location
United States , Basking Ridge
Salary
Salary:
100.00 - 120.00 USD / Hour
solomonpage.com Logo
Solomon Page
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years of clinical trial coordination/management experience
  • Global clinical trial experience required
  • Strong understanding of drug development processes
  • Strong project management and organizational skills
  • In-depth knowledge of FDA and ICH GCP guidelines
  • Excellent communication and stakeholder management abilities
  • Proactive, hands-on approach with willingness to wear multiple hats
  • Previous clinical monitoring experience
  • Experience with Microsoft PowerPoint
  • Bachelor’s degree in a science or clinical-related field required
Job Responsibility
Job Responsibility
  • Reviews, and may also contribute to the development of, clinical study-related documents
  • Helps to ensure that the study is conducted in accordance with agreed upon timelines
  • Prepares potential investigator site lists for study feasibility and assists with their evaluation and approval for inclusion in the study
  • Contributes to the planning and coordination of investigator meetings
  • Maintains relationships with assigned investigator sites, vendors and consultants
  • Ensures investigator and investigator site personnel comply with protocols
  • Assists in the oversight of the shipment of, and return of, clinical supplies
  • Maintains accurate and updated study files
  • Participates in the selection and oversight of external service providers
  • Recommends strategies for, and oversees, the execution of activities associated with clinical monitoring, safety, eligibility, enrollment, and data consistency
What we offer
What we offer
  • Medical
  • dental
  • 401(k)
  • direct deposit
  • commuter benefits
  • Fulltime
Read More
Arrow Right

Senior Clinical Trial Manager

ICON plc is a world-leading healthcare intelligence and clinical research organi...
Location
Location
South Korea , Seoul
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A minimum of 4+ years of experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organization
  • Bachelor's degree in health, life sciences, or other relevant fields of study
  • At least 10+ years of relevant experience in clinical trial management
  • Experience in managing complex or global trials is advantageous
  • Preferred: Experience in managing all trial components from start-up to database lock
  • Preferred: Experience in coaching/mentoring other CTMs, leading a team of CTMs, and participating in departmental initiatives
  • Fluency in English (reading, writing, speaking)
Job Responsibility
Job Responsibility
  • Budget Oversight: Oversee the clinical portion of the budget to ensure efficient resource allocation
  • Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight
  • Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance
  • Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines
  • Improving Study Integrity: Review trip reports and implement corrective and preventative action plans when necessary
  • Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams
What we offer
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
  • Fulltime
Read More
Arrow Right

Senior Clinical Trial Manager

ICON plc is a world-leading healthcare intelligence and clinical research organi...
Location
Location
South Korea , Seoul
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A minimum of 4+ years of experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organization
  • Bachelor's degree in health, life sciences, or other relevant fields of study
  • At least 10+ years of relevant experience in clinical trial management
  • Experience in managing complex or global trials is advantageous
  • Preferred: Experience in managing all trial components from start-up to database lock
  • Preferred: Experience in coaching/mentoring other CTMs, leading a team of CTMs, and participating in departmental initiatives
  • Fluency in English (reading, writing, speaking)
Job Responsibility
Job Responsibility
  • Budget Oversight: Oversee the clinical portion of the budget to ensure efficient resource allocation
  • Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight
  • Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance
  • Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines
  • Improving Study Integrity: Review trip reports and implement corrective and preventative action plans when necessary
  • Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams
What we offer
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
  • Fulltime
Read More
Arrow Right

Senior Clinical Trial Manager

The Sr. Clinical Trial Manager (CTM) is responsible for supporting or leading th...
Location
Location
United States , Madison
Salary
Salary:
91000.00 - 155000.00 USD / Year
exactsciences.com Logo
Exact Sciences
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in the life sciences or field as outlined in the essential duties
  • 5+ years of experience in clinical research
  • 1+ year of experience of experience leading project teams through the start-up, study conduct, data management, analysis, close out and report writing of clinical studies
  • Clinical monitoring experience including data review, query resolution, protocol deviation identification/tracking/trending, site initiation, site maintenance, and site closeout visits
  • Experience writing, reviewing and editing protocols
  • Knowledge of applicable quality standards (e.g. Good Clinical Practices (ICH/GCP), ISO 20916) and applicable local and national regulations governing clinical research
  • Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation
  • Experience providing oversight to external vendors (e.g. CRO, central labs, call centers, DCT providers)
Job Responsibility
Job Responsibility
  • Coordinate and oversee the operational aspects of a study including planning, start-up, enrollment and close out activities
  • Prepare, review and implement study related plans and documents including project timelines, study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, study budgets, site contracts & budgets, vendor management plans and other essential clinical study documents
  • Develop plans for systems and materials required to support the efficient execution of clinical studies
  • Develop, implement and maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances
  • Participate in study database development by reviewing and contributing to case report form (CRF) design, CRF completion guideline development, edit check & manual data review requirements, and participation in user acceptance testing (UAT)
  • Oversee sample management activities including planning, sample handling, kit supply management, sample shipping, processing, and resulting
  • Develop site recruitment plans and is responsible for the identification, selection, start-up and performance monitoring of clinical research sites
  • Develop study budgets and is responsible for accurately forecasting and managing study expenses
  • Oversee site contracting and study budget management
  • Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance
What we offer
What we offer
  • Paid time off (including days for vacation, holidays, volunteering, and personal time)
  • Paid leave for parents and caregivers
  • A retirement savings plan
  • Wellness support
  • Health benefits including medical, prescription drug, dental, and vision coverage
  • Bonus eligibility
  • Fulltime
Read More
Arrow Right