Director Global Site & Study Operations Job at Amgen (Cambridge)

Us Country Head, Global Site & Study Operations Senior Director

Provide strategic and operational leadership for all study and site execution wi...

Location

United States

Salary:

228624.00 - 265674.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 5 years of clinical execution experience or equivalent
Master's degree & 9 years of clinical execution experience or equivalent
Bachelor's degree & 11 years of clinical execution experience or equivalent
In addition to meeting at least one of the above requirements, you must have a minimum of 5 years' experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Job Responsibility

Provide strategic and operational leadership for all study and site execution within the assigned country or hub-and-spoke geography, ensuring delivery of the clinical portfolio in alignment with global study strategies, regulatory requirements, and Amgen quality standards
Accountable for end-to-end study, site, and site engagement execution across the assigned country or hub-and-spoke geography, delivering start-up, enrolment, retention, data quality, and patient safety outcomes in compliance with local regulations and global strategies
Provide strategic leadership for country commitments, acting as a key advisor on study feasibility, placement, and site selection, aligned to global portfolio priorities and regional strengths
Lead, line-manage, and develop the Country/Hub team, ensuring clear direction, strong performance, capability development, and succession planning to deliver portfolio and organizational objectives
Ensure adequate and timely resourcing across study delivery, site operations, and monitoring roles, working closely with global partners to match capacity and capability to portfolio demand
Drive site engagement through a clearly differentiated Amgen site experience strengthening investigator and site relationships through strong leadership, compliance, innovation, and collaboration with global study teams
Oversee country-level financial and operational management, including budgets, forecasting, vendor oversight, and efficient allocation of resources to ensure accountability and value delivery
Lead country governance and risk management, including chairing the Country Management Team (CMT),representing the country in senior governance forums, and managing risks, issues, and escalation to protect quality and delivery
Ensure regulatory compliance, inspection readiness, and continuous improvement, promoting best-practice sharing, audit readiness, and adherence to ICH-GCP, SOPs, and local regulatory 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

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.

US Country Head, Global Study & Site Operations Director

Join Amgen’s Mission of Serving Patients. Provide strategic and operational lead...

Location

United States

Salary:

211385.00 - 252852.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of clinical execution experience
Master’s degree and 8 years of clinical execution experience
Bachelor’s degree and 10 years of clinical execution experience
At least 4 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
+10 years’ work experience in life sciences or medically related field, including 8 years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
Significant experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials

Job Responsibility

Provide strategic and operational leadership for all study and site execution within the assigned country or hub-and-spoke geography
Accountable for end-to-end study, site, and site engagement execution across the assigned country or hub-and-spoke geography
Provide strategic leadership for country commitments, acting as a key advisor on study feasibility, placement, and site selection
Lead, line-manage, and develop the Country/Hub team
Ensure adequate and timely resourcing across study delivery, site operations, and monitoring roles
Drive site engagement through a clearly differentiated Amgen site experience
Oversee country-level financial and operational management
Lead country governance and risk management
Ensure regulatory compliance, inspection readiness, 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
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

Brazil Country Head, Global Site & Study Operations Associate Director

Provide strategic and operational leadership for all study and site execution wi...

Location

Brazil , São Paulo

Salary:

Not provided

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
At least 3 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
+8 years’ work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience
Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
Significant experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials
Advanced English proficiency

Job Responsibility

Provide strategic and operational leadership for all study and site execution within the assigned country or hub-and-spoke geography
Accountable for end-to-end study, site, and site engagement execution across the assigned country or hub-and-spoke geography
Provide strategic leadership for country commitments, acting as a key advisor on study feasibility, placement, and site selection
Lead, line-manage, and develop the Country/Hub team
Ensure adequate and timely resourcing across study delivery, site operations, and monitoring roles
Drive site engagement through a clearly differentiated Amgen site experience
Oversee country-level financial and operational management, including budgets, forecasting, vendor oversight
Lead country governance and risk management, including chairing the Country Management Team (CMT)
Ensure regulatory compliance, inspection readiness, 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

Executive Director, Data & Technology Site & Study Startup Support

The Executive Director, D&T Site & Study Startup Support serves as the senior te...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

15+ years of experience in clinical operations technology, Site & Study Startup processes, feasibility, regulatory workflows, or related domains
Experience implementing enterprise clinical systems and managing cross‑functional integrations
Proven ability leading global, matrixed technology or operational teams
Bachelor’s degree in Life Sciences, Engineering, Business, or related discipline required
Master’s degree or equivalent experience preferred
Deep knowledge of site and study startup processes (feasibility, submissions, activation, regulatory workflows)
Strong understanding of clinical operational systems and data flows
Expertise delivering technology solutions in regulated clinical research environments
Executive‑level communication, influence, and cross‑functional leadership
Ability to translate operational challenges into system and data improvements

Job Responsibility

Serve as the primary D&T executive partner for the global Site & Study Startup function, ensuring alignment to operational processes and startup lifecycle needs
Drive system enhancements that improve startup predictability, data capture, cycle times, and risk identification
Use innovative technology to improve effectiveness and efficiency of the business
Partner with business leaders to ensure systems availability and support for feasibility modeling, country and site selection, document collection and workflows, ICF customization, EC/RA/MoH submissions, SIV scheduling and activation readiness
Provide technology, analytical models, and data tools for feasibility assessments
Ensure real‑time access to feasibility insights, performance history, and site data across data platforms
Oversee integrations between Site & Study Startup systems and broader D&T ecosystem systems
Coordinate with regulatory and compliance technology partners to ensure consistent data flows
Ensure end‑to‑end system readiness and integration for regulatory document management, site regulatory package preparation, greenlight/activation processes, system setup and training workflows
Build and scale reporting capabilities that measure startup progress, activation risks, feasibility metrics, and regulatory timelines

What we offer

Health, Vision & Dental Insurance
Tuition Reimbursement
Vacation/Holiday/Sick Time
Flexible Spending & Health Savings Accounts
Work/Life Balance
401(k) with Company match
Pet Insurance
Opportunity to work on innovative projects at the forefront of the industry
Collaborative and inclusive work environment that values your expertise
Professional advancement and development opportunities

Senior Clinical Research Associate

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Argentina

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Patient-focused in everything we do
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Associate Director, Regional Clinical Operations

Associate Director, Regional Clinical Operations. ICON plc is a world-leading he...

Location

United States , Atlanta; Houston; Tampa; Dallas

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree with 5-7 years of experience in Clinical Trial Operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent, including at least 3 years in a role of primary responsibility for clinical trial execution and management
Thorough understanding and experience in global clinical trials in a diverse range of patient populations with preferred experience in both oncology and hematology
Direct management experience and supervisory responsibility
Demonstrated leadership and management skills
Goal oriented, self-starter with proven ability to work independently
Good knowledge and experience working with external specialist vendors
Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel
Able to proactively identify issues and provide potential solutions for resolution
Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines and to established quality standards
Proficient in Outlook/Word/Excel/PowerPoint

Job Responsibility

Accountable for oversight of all assigned studies within the country in accordance with the overall development plan and clinical operations plan and under the direction of the global team (Global Clinical Trial Manager), including adherence to quality, timelines and budget
Accountable for planning and executing assigned country study goals and commitments, and as needed, leading, organizing, and participating in regional and/or local meetings and training sessions to implement country-level recruitment plans
Develops, builds and maintains optimal relationships with key institutions within the country (i.e. Site Alliance Sites), working closely with the Medical Science Liaisons, Global Site Management and Central Services, and other departments as indicated according to the Site Engagement Strategy
Drive the identification and inclusion of sites that have access to and can enroll patients who are from groups that have been historically underrepresented in clinical trials (per FDA Guidance for Industry for Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials)
Oversees regional study feasibility, site monitoring performance, quality metrics and all relevant activities for assigned studies
Drives evidence-based site recommendations and selection
Provides support and training for sites to support diverse recruitment and retention, review, assist and optimize site-level diversity plans as needed, check and challenge progress and coordinate and align central efforts across sponsor and CROs
Align local and central initiatives and advise and guide on effective community engagement activities
Conduct co-monitoring and site identification visits, as needed
Collaborates cross-functionally to build and maintain strong relationships and interaction at the country local level (i.e. Medical Science Liaisons, Medical Monitors, Clinical Scientists, etc.) that directly contribute to key study activities and milestones

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

Select Country

Director Global Site & Study Operations

Job Description

Job Responsibility

Requirements

What we offer

Looking for more opportunities?