Clinical Research Site Project Manager Job at iconplc

Clinical Trial Manager/ Sr Clinical Trial Manager (PM/ Sr PM)

Clinical Operations Lead - Early Development Oncology. ICON plc is a world-leadi...

Location

United States , Raleigh, Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BS/BA degree or a relevant degree with strong emphasis on science, or equivalent experience
Minimum of five years of relevant experience in the biopharmaceutical industry or other relevant clinical research experience, with a focus on skills and competencies
Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health
Prior experience in assisting the conduct and management of multinational clinical trials is preferred
Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously
Experience in oncology studies required (phase I preferred)

Job Responsibility

Participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations department
Act as preliminary liaison for study sites to convey study information, answer questions and in accordance with the escalation pathway
Develop relationships with investigational sites, HCPs, and institutions to enhance conduct of the trial
Monitor study-specific timelines and key deliverables
focus on management of all relevant external vendors (e.g., Monitoring, Sample management, IVRS, Laboratory, etc)
Participate as a member of the multi-disciplinary trial(s) team
Participate in coordinating efforts with internal Pharmacovigilance, and safety group as needed
Participate in data review and discrepancy resolution as needed
Assist in the development of the IP and co-medication strategy (quantities, labels, depots, tracking, etc.) working closely with other departments
Plan and organize meetings with team support (e.g., investigator/coordinator meetings, DMC, SMC, safety call, etc.) as appropriate

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

Clinical Research Associate II / Senior Clinical Research Associate Large Pharma

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

Location

Germany , Frankfurt

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Master or Bachelor's degree in a scientific or healthcare-related field
Minimum of 2 years of experience as a Clinical Research Associate
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines
Strong organizational and communication skills, with attention to detail
Ability to work independently and collaboratively in a fast-paced environment
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 skills in German and English
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

Internship - Clinical Research Project in Digital Dentistry

We are looking for a motivated dental student to conduct a research year working...

Location

Denmark , Copenhagen

Salary:

Not provided

3Shape

Expiration Date

Until further notice

Requirements

Be enrolled in a dentistry program
Have a strong interest in clinical research and evidence-based dentistry
Demonstrate a high level of organization, attention to detail, and professionalism
Possess proficient communication skills in Danish and English
Have flexibility to possibly commute between different sites (Classensgade clinic and 3Shape office)

Job Responsibility

Participation in clinical data and image acquisition
Data management and documentation in accordance with Good Clinical Practice (GCP)
Support in study coordination and execution
Contribution to data analysis and interpretation
Opportunity to contribute to drafting a scientific manuscript for publication

What we offer

Central Copenhagen location
3Shape is a globally recognized tech company
An attractive healthcare package to keep you fit and well
Breakfast every day, and a delicious and healthy lunch cooked by our private chefs
A joint purpose: to enable dentists to provide superior dental care to every patient, every time

Fulltime

Clinical Project Manager - Early Phase Trials

As a part of the global Project Leadership group at Parexel, you are responsible...

Location

United States , Remote

Salary:

125000.00 - 138000.00 USD / Year

Parexel

Expiration Date

Until further notice

Requirements

2 years of Project Management experience with Parexel or 3 to 5 years in related fields
Experience as a Functional Team Leader or in coordinating clinical trials
Knowledge of ICH-GCP and pharmaceutical industry regulations
Proficiency in MS-Office products
Bachelor’s degree in a science-related field or equivalent work experience

Job Responsibility

Lead cross-functional teams to deliver high-quality and patient-focused clinical trials
Collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets
Manage the financial aspects of projects, including revenue recognition, milestone payments, and monthly pass-through invoices
Own the sponsor relationship and manage sponsor communication
Serve as the central point of contact and escalation for functional teams
Proactively communicate project progress, risks, and solutions to sponsors and internal teams
Lead regular meetings with sponsors and project teams to ensure objectives are met
Review relevant materials and attend strategy meetings
Prepare for Bid Defense and develop project management strategies
Attend Bid Defense and handover meetings

What we offer

Annual performance-based bonus plan
Annual salary review
Additional total rewards incentives
Paid time off
401k match
Life insurance
Health insurance
Other benefit offerings in accordance with the terms of applicable plans

Fulltime

Clinical Research Manager

We are seeking an experienced and detail-oriented Clinical Research Manager to o...

Location

Sweden , Stockholm

Salary:

Not provided

EnglishJobs.se

Expiration Date

Until further notice

Requirements

Degree in Life Sciences, Medicine, Pharmacy, or a related field
Experience in clinical research, clinical trial management, or a similar role
Strong knowledge of clinical trial processes, GCP, and regulatory requirements
Experience managing multi-site or international clinical studies
Familiarity with clinical trial management systems (CTMS) and data management tools
Strong organizational and project management skills
Excellent attention to detail and commitment to quality and compliance
Strong communication and stakeholder management abilities
Ability to manage multiple studies and priorities simultaneously
Analytical thinking with the ability to interpret clinical data

Job Responsibility

Plan, manage, and oversee clinical trials across multiple phases and sites
Ensure studies are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP), and internal standards
Develop and manage study timelines, budgets, and resources
Coordinate with clinical research associates, investigators, and vendors to ensure smooth study execution
Monitor study progress, identify risks, and implement mitigation strategies
Oversee data collection, quality, and integrity throughout the trial process
Prepare and review study documentation, including protocols, reports, and regulatory submissions
Ensure timely reporting of adverse events and compliance with safety regulations
Collaborate with regulatory, medical, and data management teams
Lead study close-out activities and contribute to final reporting and analysis

What we offer

Collaborative and international work environment within the healthcare and life sciences sector
Opportunities to contribute to impactful clinical research and innovation
Professional development and career advancement opportunities
Access to advanced clinical research tools and technologies
Competitive compensation and benefits package

Fulltime

Clinical Project Manager III

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelo...

Location

United States , Bedford

Salary:

135000.00 - 155000.00 USD / Year

werfen

Expiration Date

Until further notice

Requirements

Medical Technologist degree or BS in STEM is preferred
Minimum of 4 years experience in clinical project or research management
Minimum of 2 years' experience leading CRAs
Experience in design and development of medical instrumentation
Clinical Research Associate (CRA) certification or equivalent certification in project management is desired
Working knowledge of Good Clinical Practice (GCP) / Good Study Practice (GSP) as described by US Food and Drug Administration (FDA), World Health Organization (WHO), International Conference on Harmonization (ICH), and International Standards Organization (ISO)
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement
Problem solving, conflict management, listening, managing and measuring work
Strong project management skill set and familiarity with project management tools and techniques
Team player, self-motivated, perseverance

Job Responsibility

Provide technical and team leadership to one or more small clinical project team(s), including planning, scheduling, and technical leadership within the project area. Coordinate roles and responsibilities within the clinical project team
Responsible for clinical project planning and scheduling, utilizing deliverable milestone methods and critical path scheduling, and developing task and project estimates. At the Program Manager's, Clinical Research managers, or Clinical Director's request provide a schedule and budget forecast for the project
Responsible for conducting regular clinical project team status meetings and reviews. Plan and schedule technical reviews at appropriate clinical project milestones. Ensures deliverables are completed and documented according to Good Clinical Practice and per design control
Responsible for coordination of clinical project resources to identify the root cause(s) of clinical project issues, and develop and manage a plan to fix, test, and implement an appropriate solution through completion. If needed, coordinate with cross-functional team resources to support root cause initiatives
Responsible for insuring clinical project risks, both technical risks and management risks, are identified and appropriate risk mitigation plans are developed and executed. Track and respond to risk triggers. Regularly assess and report the status of overall clinical project risk to the development project team and Clinical Research Manager
Creates and maintains Trial Master File(s) and corresponding Design Control files to current study ensuring accuracy
Responsible for communication within clinical project team, development project team, and to clinical program management and department management. Develop and implement a project communication plan
Coordinates with study sites and internal service suppliers (i.e., Biobanking, Field Service Engineers, etc.) to ensure project deliverables are completed correctly and on time or that services are provided in accordance with the project plan
Able to identify and obtain support to resolve project team conflict. As necessary, work with development project leader to resolve cross-team conflicts. Able to remove oneself from the problem. Fosters creative, professional climate that will maximize the contributions of the multi-disciplinary clinical project team members
Participates in activities focused on improving the efficiency and effectiveness of the product development processes and procedures

What we offer

medical insurance
dental insurance
vision insurance
401k plan retirement benefits with an employer match
paid vacation
paid sick leave

Fulltime

Junior Manager Clinical Research

At Fresenius Medical Care, we are the global leader in kidney care, committed to...

Location

Germany , Bad Homburg

Salary:

Not provided

FMS USA Fresenius Mgmt Services Inc

Expiration Date

Until further notice

Requirements

Scientists or medical professionals with experience in conducting clinical trials of drugs and medical devices
Knowledge and experience in planning and conducting clinical trials, regulatory requirements for clinical trials, and the further utilization of clinical data (clinical evaluation, scientific publications, presentations)
Experience in project management
Structured, goal-oriented approach to work
Interest in new tasks
Analytical skills
Collaborative personality
Ability to mediate between unclear or conflicting positions
Ability to handle stress
Confident demeanor

Job Responsibility

Selection of competent and appropriate clinical research organisation (CRO) and other service providers
Negotiation of legal and financial terms and conditions concerning agreement with CRO or other service provider for preparatory activities and performance of planned studies
Continuous exchange with CRO and other qualified service providers in regular meetings (“Jour-fixe”)
Collaboration with FMC concerning concept, planning and performance of planned studies
Collaboration with FMC concerning preparation and review of synopsis´ and study protocols of planned studies
Preparation of concept, planning and performance of meetings of the (coordinating) investigators of the ongoing studies
Communication with all involved (coordinating) investigators of the studies, e.g., concerning the implementation of the study in the specific countries or for review of study documents etc.
Training of field sales force amongst others of participating countries taking part in the planned studies
Provision of regular updates concerning the ongoing studies within FMC core team
General collaboration with other departments of Fresenius Medical Care concerning studies (e.g., compliance and legal department etc.)

What we offer

Individual opportunities for self-determined career planning and professional development
A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
A large number of committed people with a wide range of skills, talents and experience
The benefits of a successful global corporation with the collegial culture of a medium-sized company

(Junior) Manager Clinical Research

At Fresenius Medical Care, we are the global leader in kidney care, committed to...

Location

Germany , Bad Homburg

Salary:

Not provided

Fresenius Kidney Care Eupora

Expiration Date

Until further notice

Requirements

Scientists or medical professionals with experience in conducting clinical trials of drugs and medical devices
Knowledge and experience in planning and conducting clinical trials, regulatory requirements for clinical trials, and the further utilization of clinical data (clinical evaluation, scientific publications, presentations)
Experience in project management
Structured, goal-oriented approach to work
Interest in new tasks
Analytical skills
Collaborative personality
Ability to mediate between unclear or conflicting positions
Ability to handle stress
Confident demeanor

Job Responsibility

Selection of competent and appropriate clinical research organisation (CRO) and other service providers
Negotiation of legal and financial terms and conditions concerning agreement with CRO or other service provider for preparatory activities and performance of planned studies
Continuous exchange with CRO and other qualified service providers in regular meetings ("Jour-fixe")
Collaboration with FMC concerning concept, planning and performance of planned studies
Collaboration with FMC concerning preparation and review of synopsis´ and study protocols of planned studies
Preparation of concept, planning and performance of meetings of the (coordinating) investigators of the ongoing studies
Communication with all involved (coordinating) investigators of the studies, e.g., concerning the implementation of the study in the specific countries or for review of study documents etc.
Training of field sales force amongst others of participating countries taking part in the planned studies
Provision of regular updates concerning the ongoing studies within FMC core team
General collaboration with other departments of Fresenius Medical Care concerning studies (e.g., compliance and legal department etc.)

What we offer

Individual opportunities for self-determined career planning and professional development
A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
A large number of committed people with a wide range of skills, talents and experience
The benefits of a successful global corporation with the collegial culture of a medium-sized company

Fulltime

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Clinical Research Site Project Manager

Job Description

Job Responsibility

Requirements

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