Clinical Research Site Project Manager Job at iconplc

Clinical Research Associate II/Sr. Clinical Research Associate - Oncology

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

Location

United States

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
Must be fluent in English and in the native language(s) of the country they will work in
Ability to travel 60-80%
Valid driver’s license and passport required
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's 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
Serve as the primary point of contact for assigned investigator sites
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with Site Care Partner 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
Attend investigator meeting when required (virtual or F2F)
Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
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

What we offer

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

Senior Clinical Research Associate

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

Location

Taiwan , Taipei

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree in a relevant field such as life sciences, nursing, or medicine
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license

Job Responsibility

Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations

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

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Senior Clinical Research Coordinator

The Computational Health Informatics Program (CHIP) is seeking an experienced, h...

Location

United States , Boston

Salary:

58676.80 - 93901.60 USD / Year

Boston Children's Hospital

Expiration Date

Until further notice

Requirements

Bachelor’s degree
Master’s preferred
Bachelor’s degree and 4 years of relevant work experience OR Master’s degree and 2 years of relevant work experience
Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex
Well-developed communication skills to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions
Ability to effectively engage with and influence others
build working relationships and can work independently and as a team member, leads others when needed
Act as a resource and must be knowledgeable and compliant in all hospital, State, and Federal regulatory requirements, including hospital policy and procedures

Job Responsibility

In conjunction with the Principal Investigator and/or designees designs, develops, and implement clinical research projects such as enrollment strategies, study materials, and study documents
Responsible for daily operations of the study
Develops and implements processes and procedures to meet study goals and protocol requirements
Participate in training and prepare study related training materials
Plans and prioritizes the work of administrative and support personnel on all clinical study activities
Consents and enrolls patients for research studies by providing detailed information on the Clinical Study to patients and families
Communicates all policies and procedures and responds to all inquiries
Evaluate the suitability of prospective study candidates and make selections based on clinical knowledge of each study
Provide input for updates of SOPs and drafting of new quality documentation
Assist with developing and implementing best practice guidelines for conducting various clinical research protocols

What we offer

flexible schedules
affordable health, vision and dental insurance
child care and student loan subsidies
generous levels of time off
403(b) Retirement Savings plan
Pension
Tuition and certain License and Certification Reimbursement
cell phone plan discounts
discounted rates on T-passes

Fulltime

Clinical Trial Operations Associate

Beacon Biosignals is on a mission to revolutionize precision medicine for the br...

Location

United States , Boston

Salary:

Not provided

Beacon Biosignals

Expiration Date

Until further notice

Requirements

Experience in clinical project management or clinical operations roles
Strong organizational and project management skills, with the ability to manage multiple responsibilities effectively
Excellent written and verbal communication skills in English
A proactive mindset with the ability to identify priorities and anticipate challenges
Meticulous attention to detail, ensuring accuracy in data collection and reporting
Familiarity with GCP, ICH guidelines, and clinical research regulatory requirements
A desire to learn more about analytics, statistics, machine learning, and clinical trials

Job Responsibility

Collaborate with project teams to support study startup activities
Act as the primary point of contact for clinical sites, ensuring smooth operations and clear communication
Provide training to research sites on the use of Beacon’s devices and study protocols, ensuring proper device usage and data collection
Monitor project progress, ensuring adherence to timelines, protocols, and quality standards
Maintain compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory standards
Address operational issues promptly, escalating through tools like Zendesk and Asana for resolution
Provide actionable feedback from research sites to inform improvements in devices and workflows

What we offer

equity
PTO

Senior Clinical Supplies Project Manager

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

Location

United Kingdom , Reading

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor degree or equivalent, preferably in a scientific or pharmaceutical discipline
At least three 2-3 years of experience in clinical supplies planning/supply chain management, with (5) years of experience in clinical supplies, clinical research or pharmaceutical development
Working knowledge of the Clinical Trial Supply process
Working knowledge of project team structure and processes
Proactive approach to work, identifying potential issues well in advance and bringing them to the attention of appropriate personnel for resolution.
Knowledge of project management and Clinical customer relationship building
Knowledge of the ‘Customers’ team structures and processes
Excellent verbal and written communication skills
Ability to influence others
Ability to multi-tasks

Job Responsibility

Manage clinical supply planning and forecasting for study protocols
Serve as member of clinical study team and/or clinical drug supply team, as assigned
Interpret relevant protocol information to develop packaging/labeling design and/or global distribution strategy
Support design and set-up of IRT system
Support financial planning for global clinical supplies, including budgeting, forecasting, and strategic planning activities for clinical trials and pharmaceutical development pipeline
Coordinate the origination, proofing and translation of clinical study labels, as required
Monitor global clinical supply inventory at the clinical site level for both IRT and traditional studies via tracking of specific milestone dates and adjusting drug distribution plan accordingly
Coordinate drug supply delivery timelines with Clinical, packaging source area(s), and indirectly with GMP laboratories, QA and Regulatory Affairs, as required
Maintain close communications with all internal-chain groups to ensure the adequate supply of clinical supplies throughout the duration of a clinical trial
Serve as ‘consultant’ for managers throughout the organization on issues related to clinical supplies and project management

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

Director, Clinical Affairs

In this role, you will lead the development and execution of clinical strategies...

Location

United States , Skaneateles Falls

Salary:

208000.00 - 286000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Minimum: BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
medical device preferred)
Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements, as applicable to a study (or the requirements within countries in which a study is conducted)
Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation as required
Possesses expert knowledge of research objectives, protocol design, and data collection standards
Experience reviewing monitoring reports. High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
Able to monitor performance of team in maintaining system updates to allow for senior management reports
Applies current applications/systems to compile information for presentation or distribution
Identifies new uses of current systems or use of new applications to enhance the management capabilities of projects
Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE

Job Responsibility

Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
Clinical Strategy Development: Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources as required as inputs for priority needs and to advise the execution strategy
Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
Conduct Clinical Research: Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
Lead Clinical Study Execution team(s) to develop clinical strategies (and project plan) to efficiently manage the project(s) and maintain regulatory compliance
Clinical Plan - Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program
Clinical Trial Protocols - Facilitate preparation of protocols including study design, case report forms, study procedures

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Director, Clinical Affairs

In this role, you will lead the development and execution of clinical strategies...

Location

United States , Skaneateles Falls

Salary:

208000.00 - 286000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
medical device preferred)
Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements, as applicable to a study (or the requirements within countries in which a study is conducted)
Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation as required
Possesses expert knowledge of research objectives, protocol design, and data collection standards
Experience reviewing monitoring reports. High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE
Expertise in project management practices
Ability to provide positive direction to team as well as identify problems/issues and work towards resolution
Exceptional organizational and team leadership skills

Job Responsibility

Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
Clinical Strategy Development: Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources as required as inputs for priority needs and to advise the execution strategy
Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
Conduct Clinical Research: Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
Lead Clinical Study Execution team(s) to develop clinical strategies (and project plan) to efficiently manage the project(s) and maintain regulatory compliance
Clinical Plan - Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program
Clinical Trial Protocols - Facilitate preparation of protocols including study design, case report forms, study procedures. Develop and complete enrollment feasibility evaluations based on protocol synopsis. Draft informed consents based on study and regulatory requirements

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Clinical Research Site Project Manager

iconplc

Location:
United States

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 14, 2026

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