Early Development Clinical Research Associate Job at iconplc (Frankfurt)

Japan Clinical Leader

Responsible for clinical development of the assigned project in Japan under the ...

Location

Japan , Tokyo

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Scientific background in education
>3 years or more experience in clinical development
Experience in clinical development
Thorough understanding of the processes associated with clinical and regulatory submissions
Skill to design and execute development strategies (e.g. advanced medical and pharmaceutical knowledge, skill to design development strategies, knowledge on clinical study operations including guidelines and SOPs, skill to think logically, innovatively, and flexibly, writing skills)
Leadership skills
Team building skills, networking skills
Negotiation skills, consensus building skills
Problem solving skills
Project management skills

Job Responsibility

Evaluate candidates for development in the assigned TA/DA from scientific and technical aspects and formulate an effective development plan for Japan with the JDL and the global team
Contribute to establishing the global development plan by discussing points to consider in developing the product (including biomarkers and diagnostics) and obtaining approval in Japan (e.g. medical practice, communication with the government) with the global team and considering strategies towards early launch
Establish good working relationships with internal and external stakeholders [e.g. key opinion leaders (KOL), academic society, patient group] to enhance the possibility of expedited development and early approval with the JDL and senior JCL
Lead Japan Development Team (JDT) and clinical studies of assigned project to success in cooperation with JDT and global team members
Communicate closely with the GCL and Clinicians in Worldwide Research and Development (WRD) and respective Business Units (BU) and build and execute an effective development strategy
Prepare high quality documents (e.g.study outline, briefing document, CTD, query response, publications) and review them
When a Clinical Scientist (CS) is assigned to the project, review the documents prepared by the CS (e.g. full protocol, informed consent document, investigator's brochure)
when a CS is not assigned, the JCL is responsible to prepare and review these documents
Contribute to the preparation of the risk management plan for J-NDA submission and other documents required after approval
Review clinical data and protocol deviations and determine necessary actions for clinical studies in which he/she is the Clinical Lead

Fulltime

Clinical Outcomes Assessment Analyst

Clinical Outcome Assessment Analyst. ICON plc is a world-leading healthcare inte...

Location

United States , CARY, BLUE BELL, INDIANAPOLIS, MIAMI, TAMPA, DALLAS, HOUSTON

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Master’s degree or PhD in psychology, psychometrics, biostatistics, health outcomes, or related field
Minimum 3 years of experience in COA development, validation, and/or application in clinical research (pharma, biotech, or CRO setting)
Strong understanding of FDA and EMA guidance on COAs and patient-focused drug development
Proficiency in psychometric methods and statistical software (e.g., SAS, R, Mplus, or similar)
Excellent written and verbal communication skills with ability to summarize complex data
Strong organizational skills and ability to manage multiple projects independently
Relevant drug development and/or commercialization experience within the pharmaceutical industry with strong knowledge of patient, regulator, and payer requirements
Significant demonstrated experience in developing and implementing strategies to apply scientific methods associated with the measurement, assessment and translation of the patient experience in multiple disease areas
Knowledge of the regulatory environment with particular knowledge of FDA Patient Focused Drug Development guidance, relevant guidance from other regulatory bodies, and evidentiary standards for Clinical Outcomes Assessment (e.g. PROs, ObsROs, ClinROs, PerfOs) label claims.

Job Responsibility

Execute and ensure the effective execution of work plans resulting in the development of relevant, reliable, and timely evidence for patients, regulators, clinicians, caregivers, and payers
Design and execution of research to inform COA strategy development
Develop and execute psychometric analysis strategy
Support clinical trial development for assigned programs, including relevant portions of protocols, statistical analysis plans, study reports, briefing books, and related documents
Identify gaps in available evidence needed to support fit-for-purpose use of COAs in a specified context
As needed, design and execute research to develop or modify COA instruments for inclusion in assigned programs
Consult on COA regulatory strategy
Create and oversee the creation of scientific materials that are submitted to regulators ensuring consistent quality
Develop publications of early COA research for disclosure in peer-reviewed journals and at scientific meetings
Ensure effective packaging of information and scientific materials for patients and caregivers for dissemination and disclosure

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.

Parttime

Japan Clinical Leader

Responsible for clinical development of the assigned project in Japan under the ...

Location

Japan , Tokyo

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Scientific background in education
>3 years or more experience in clinical development
Experience in clinical development
Thorough understanding of the processes associated with clinical and regulatory submissions
Skill to design and execute development strategies (e.g. advanced medical and pharmaceutical knowledge, skill to design development strategies, knowledge on clinical study operations including guidelines and SOPs, skill to think logically, innovatively, and flexibly, writing skills)
Strong leadership skills
Team building skills
Networking skills
Negotiation skills
Consensus building skills

Job Responsibility

Evaluate candidates for development in the assigned TA/DA from scientific and technical aspects and formulate an effective development plan for Japan with the JDL and the global team
Contribute to establishing the global development plan by discussing points to consider in developing the product (including biomarkers and diagnostics) and obtaining approval in Japan (e.g. medical practice, communication with the government) with the global team and considering strategies towards early launch
Establish good working relationships with internal and external stakeholders [e.g. key opinion leaders (KOL), academic society, patient group] to enhance the possibility of expedited development and early approval with the JDL
Lead Japan Medicine Team (JMT) and clinical studies of assigned project to success in cooperation with JMT and global team members
Communicate closely with GDL and Clinicians in Worldwide Research and Development (WRD) and respective Business Units (BU) and build and execute an effective development strategy
Prepare high quality documents (e.g. study outline, briefing document, CTD, query response, publications) and review them
Contribute to the preparation of the risk management plan for J-NDA submission and other documents required after approval
Review clinical data and protocol deviations and determine necessary actions for clinical studies in which he/she is the Clinical Lead
Review individual subject and cumulative safety data based on the safety review plan
Lead preparation of procedures related to independent data monitoring committee, adjudication committee, and safety review committee, and manage and execute the committees

Fulltime

Associate Director Biostatistics

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN)...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate in Statistics/Biostatistics (or related subject with high statistical content) with at least 12+ years of post-graduate statistical experience in the pharmaceutical industry or medical research
Master’s degree in Statistics/Biostatistics (or related subject with high statistical content) with at least 16+ years of post-graduate statistical experience in the pharmaceutical industry or medical research

Job Responsibility

Provide sound statistical guidance to clinical development, reimbursement, and medical affairs
Oversee statistical contributions to protocols, randomization specifications, statistical analysis plans (SAPs), clinical study reports (CSRs), and key trial documents
Ensure alignment of study design and analysis with scientific rigor, regulatory requirements, and Amgen policies
Collaborate cross-functionally with global teams to deliver high-quality analyses, publications, and regulatory filings
Contribute to innovative trial designs, advanced methodologies, and process improvement initiatives
Execute biostatistical strategies across the product lifecycle, from early development through post-marketing
Provide consultancy and training to colleagues across R&D
Support governance of outsourced statistical activities, ensuring adherence to Amgen standards and regulatory compliance
Represent Biostatistics in cross-functional and external interactions (e.g., with regulatory agencies, investigators, or data monitoring committees)
Drive technology adoption leveraging AI capabilities to streamline statistician’s work

What we offer

Vast opportunities to learn and develop within our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Heor scientist

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

Location

United States , RALEIGH, BLUE BELL, BASKING RIDGE, NJ, CHICAGO, IL, SEATTLE, WA, DALLAS, TX, HOUSTON, TX

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Doctorate (PhD, MD) OR PharmD/MS degree with 10-12+ years of experience in creating, executing, and delivering outcomes strategies/projects
Strong comprehension and communication skills including the ability to translate and disseminate complex scientific information in a clear and concise manner
Excellent written and verbal communication skills
Demonstrated ability to influence and collaborate within and across teams

Job Responsibility

Drives sustained integration of HEOR from early clinical development through commercialization depending on focus of role
Develops and oversees HO research strategy for compounds in the client portfolio in the relevant therapeutic area(s)
Serves as a strategic partner on lead/core teams throughout development and/or commercialization
Formulates and drives Patient Focused Outcome, Real World Evidence, and/or economic value strategies for priority products and geographies
Develops bold high impact science for products across the lifecycle, to influence and support evidence needs for products in support of improving patient outcomes
Applies technical expertise appropriate for the role (e.g., scope or depth in statistical analysis, economic modeling, clinical trials, PFO development, observational/ epidemiologic research, and health technology or other value assessment) within a therapeutic area
Applies disease state knowledge and research methods to solve HO issues associated with registration, pricing, reimbursement, and access initiatives
Links technical expertise with business acumen and establishes and maintains strategic relationships with key internal and external decision makers
Effectively leads HO evidence planning and implementation in collaboration with cross-functional teams across the development and commercialization lifecycle teams
Effectively integrates with and influences key business partners and external stakeholders to achieve goals and outcomes

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

New

Clinical Scientist Associate Director - Late Development, Oncology

In this role, the Associate Medical Science Director (Associate MSD) supports ea...

Location

Portugal , Lisbon

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of life sciences/healthcare experience
Master’s degree and 5 years of life sciences/healthcare experience
Bachelor’s degree and 7 years of life sciences/healthcare experience
3 years of pharmaceutical clinical drug development experience
Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
Industry or academic experience supporting early or late-phase drug development within a relevant therapeutic area or disease indication
Strong communication and presentation skills, with the ability to clearly convey scientific concepts and clinical data to cross-functional teams and leadership audiences, both written and oral
Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements
Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, and generation of clinical data outputs
Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance

Job Responsibility

Support set up and execution of late phase clinical trials with a focus on data quality
Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity
Provide input into & implementation of data management plan, CRF design, and data review oversight
Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
Assists Development Lead and Medical Sciences Director in medical monitoring and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
Anticipate and actively manage problems across a broad spectrum of cross-functional teams
Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
Support appropriate training, recruitment, and development requirements for matrix team resources

What we offer

Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements

New

Clinical Scientist Associate Director - Late Development, Oncology

In this role, the Clinical Scientist Associate Director supports late-phase clin...

Location

Portugal , Lisbon

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of life sciences/healthcare experience
Master’s degree and 5 years of life sciences/healthcare experience
Bachelor’s degree and 7 years of life sciences/healthcare experience
3 years of pharmaceutical clinical drug development experience
Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
Industry or academic experience supporting early or late-phase drug development within a relevant therapeutic area or disease indication
Strong communication and presentation skills in English
Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements
Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, and generation of clinical data outputs
Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance

Job Responsibility

Support set up and execution of late phase clinical trials with a focus on data quality
Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity
Provide input into & implementation of data management plan, CRF design, and data review oversight
Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
Assists Development Lead and Medical Sciences Director in medical monitoring and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
Anticipate and actively manage problems across a broad spectrum of cross-functional teams
Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
Support appropriate training, recruitment, and development requirements for matrix team resources

What we offer

Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements

Fulltime

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

Early Development Clinical Research Associate

iconplc

Location:
Germany , Frankfurt

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 26, 2026

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