Clinical Research Manager Job at EnglishJobs.se (Stockholm)

Clinical Research Associate/Senior Clinical Research Associate

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

Location

United States , Midwest, West region

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
Good knowledge of relevant local regulations
Good medical knowledge and ability to learn relevant Client Therapeutic Areas
Basic understanding of the drug development process
Good understanding of Clinical Study Management including monitoring, study drug handling and data management
Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification
Ability to travel nationally/internationally as required
Valid driving license per country requirements, as applicable
Oncology Experience required
Proficient in written and spoken English language required

Job Responsibility

Contributes to the selection of potential investigators
Accountable for study start-up and regulatory maintenance (in some countries)
Trains, supports, and advises Investigators and site staff in study related matters
Confirms that site staff have completed required training
Actively participates in Local Study Team (LST) meetings
Contributes to National Investigators meetings
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents
Drives performance at the sites
Updates CTMS and other systems
Manages study supplies, drug supplies and drug accountability

What we offer

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

Fulltime

Clinical Research Associate/Senior Clinical Research Associate- FSP

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

Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
Good knowledge of relevant local regulations
Good medical knowledge and ability to learn relevant Client Therapeutic Areas
Basic understanding of the drug development process
Good understanding of Clinical Study Management including monitoring, study drug handling and data management
Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification
Excellent attention to detail
Good written and verbal communication skills
Good collaboration and interpersonal skills
Good negotiation skills

Job Responsibility

Contributes to the selection of potential investigators
As required, accountable for study start-up and regulatory maintenance
Trains, supports, and advises Investigators and site staff in study related matters
Confirms that site staff have completed and documented the required training appropriately
Actively participates in Local Study Team (LST) meetings
Contributes to National Investigators meetings
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents
Drives performance at the sites
Updates CTMS and other systems with data from study sites
Manages study supplies, drug supplies and drug accountability at study site

What we offer

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

Clinical Research Associate II/Senior Clinical Research Associate

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

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
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock
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
Attend investigator meeting when required
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
Submit all required reports, documentation, updates and tracking within required timeframes
Identify and resolve investigator site issues within required timeframes

What we offer

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

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

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

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 Manager

Job Description

Job Responsibility

Requirements

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