Early Development Clinical Research Associate Job at iconplc (Frankfurt)

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

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

Senior Clinical Trial Manager

Sr Local Trial Manager – Solid Tumor Oncology - Home Based (US) ICON plc is a wo...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree
Degree in a health or science related field
3 - 5+ years of trial end to end management experience
Solid Tumor Oncology experience required
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
Strong IT skills in appropriate software and company systems
Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate
To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
Collaborates with central study team and local stakeholders as applicable for final selection of sites to participate in trial
Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations
Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial
Focuses on investigator engagement through timely follow up with sites
Promptly communicates relevant status information and issues to appropriate stakeholders
Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress
When necessary initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams and Quality & Compliance team

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

Associate Director, Market Access Portfolio Strategy

The Associate Director, Market Access Portfolio Strategy will be part of the Mar...

Location

United States

Salary:

160300.00 - 297700.00 USD / Year

myGwork - LGBTQ+ Business Community

Expiration Date

Until further notice

Requirements

Education: Bachelor's degree required
MBA, Health Policy, or equivalent preferred
Minimum of 5 years of pharmaceutical experience in Market Access, Healthcare Strategy Consulting, Policy, Managed Care Finance, Insights & Analytics or Business Development
3+ years with direct US Market experience is preferred
Demonstrated familiarity with and ability to manipulate industry standard claims and/or payer data (e.g. IQVIA, DRG Fingertip Formulary), or other published sources of price and payer coverage information
Strong interpersonal, communication, and influencing skills combined with an ability to successfully collaborate across a matrix organization
Demonstrated prioritization, organizational, and analytical skills as well as the ability to create solutions for complex processes and procedures
Ability to analyze complex business issues and trends and to connect commercial, financial, and clinical perspectives to develop enhanced value propositions
Demonstrated high degree of emotional intelligence, adaptability, and creativity

Job Responsibility

Ensure that the Market Access Early Pipeline team forecasting model assumptions are kept current by developing a deep understanding of and updating the data assumptions that underpin many of the calculations on a regular basis
Catalogue market trends that we track to ensure that the list is complete, assumptions are current, and trends are effectively communicated across the US Market Access organization and relevant cross-functional stakeholders
Work with Directors, Market Portfolio Strategy to support ongoing market analyses by gathering data and insights and using these findings to inform methodologies and story development
Draft and communicate updates to the US Market Access Outlook and ensure content from the US Market Access Outlook gets repurposed and used across the organization
Gather and maintain a meaningful catalogue of above-brand initiatives being performed across the US Market Access organization so that the Market Access Leadership Team can ensure appropriate visibility and participation across the organization
Present findings from analyses at various levels across the organization
Participate in development of relevant market research, including learning and following all internal processes, analyzing secondary data, and incorporating internal Novartis experience to inform insights
Organize the annual business planning process for the team

What we offer

performance-based cash incentive
eligibility to be considered for annual equity awards
health, life and disability benefits
401(k) with company contribution and match
generous time off package including vacation, personal days, holidays and other leaves

Fulltime

Consultant in Acute Medicine

An exciting opportunity has arisen for a Consultant in Acute Medicine to join an...

Location

United Kingdom , Greater London

Salary:

109725.00 - 145478.00 GBP / Year

Remedium Partners

Expiration Date

Until further notice

Requirements

MBBS or equivalent medical qualification
MRCP or equivalent
Full GMC registration with a licence to practise
Entry on GMC Specialist Register for Acute Medicine or General Internal Medicine (or within 6 months of CCT/CESR)
Minimum 1 year NHS experience
Broad experience in Acute Medicine and General Internal Medicine
Demonstrated leadership in acute clinical environments
Experience supervising junior doctors and multidisciplinary staff
Evidence of service development, audit, or research involvement
Evidence of completed clinical audit within the last 18 months

Job Responsibility

Provide senior clinical leadership across AMU, AAU, Acute Admissions, SDEC, and post-take/outlier activity
Lead consultant ward rounds and ensure early senior assessment of acute admissions
Support rapid assessment, clinical decision-making, and discharge planning
Undertake practical procedures and contribute to the management of complex acute medical patients
Participate in the General Internal Medicine on-call rota and weekend cover
Lead MDT discussions and coordinate patient pathways across acute and community interfaces
Work collaboratively with ED, speciality teams, and community partners to improve patient flow
Support operational management and ongoing development of Acute Medicine services
Contribute to pathway development aligned with GIRFT and national best practice
Provide clinical supervision and mentorship to trainees, fellows, and physician associates

Fulltime

Senior Manager, Evidence Generation Lead

The medical Director, evidence generation is responsible for supporting strategi...

Location

Belgium , Mechelen

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum of 7+ years of experience in evidence generation, clinical development, HEOR, or a related field, with at least 5 years of experience in Epidemiology, Health Economics Outcomes Research (HEOR), or/and Health Systems Research
Proven track record of developing and implementing integrated evidence generation plans in the pharmaceutical or biotechnology industry
Experience in design, conduct and oversight of real-world evidence studies ranging from protocol writing to project management oversight and data interpretation and communication
Solid understanding of the cross functional drug development lifecycle and processes (Business Development, clinical trial design, conduct, & endpoint selection, Clinical Operations, Data Management, Biostatistics, and Regulatory)
Demonstrated expertise and experience working with methods for evidence generation using primary and secondary data sources, knowledge of common issues and challenges of implementation, and track-record of successful publications
Demonstrated depth of understanding of observational research methods, regulatory standards, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
Evidence of technical expertise of applying pharmacoepidemiology evidence and insights at the therapy/product level
Ability to explain strengths and limitations of clinical practice datasets — such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources — in context of designing pharmacoepidemiology study designs
Ability to work successfully in a matrix and quick paced environment
Ability to multitask priorities to align with program objectives

Job Responsibility

Collaborate with cross-functional colleagues to Lead the development and execution of Medical evidence generation strategy and tactics supporting products in development as well as those commercially available, with appropriate prioritization and use of resources ensuring alignment with corporate goals, regional needs, and therapeutic priorities
Oversee the Design and implementation of Integrated Evidence Generation Plans (IEGPs) that incorporate clinical, real-world, and economic data to support product positioning and value demonstration
Scope RWE studies (Regional/National/Academic/Patient/Vendor), selection of new or existing academic (can include: ISR/lIS/NIS)/non-governmental registries (retrospective/prospective), management across various phases from start up, maintenance to final deliverables
Translate (early) trial efficacy to real-world comparative effectiveness as part of early and late phase study planning, identification of subpopulations, and for potential risk-sharing purposes
Design and implement multiple database and/or de novo (e.g. registries) pharmacoepidemiologic studies, as well as literature reviews, intended to provide insight into background epidemiology, disease state regular care, and/or quantify benefits and/or risks potentially associated with Alfasigma products
Project management oversight – ensuring effective design, initiation and implementation of real world evidence studies, while ensuring effective study protocols and plans, managing budget and milestone tracking, and where appropriate contracting with partner organizations
keep abreast on new data and developments in the field, key publications of interest, research methodologies and regulatory standards across the EU and New Markets regions and proactively address HOR strategy changes in collaboration with global and regional teams in anticipation of any trends
Review and provide relevant RWE/HOR inputs to statistical analysis plans and analysis outputs
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
Establish metrics to evaluate the effectiveness and impact of evidence generation activities on corporate and product-specific objectives

What we offer

We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development

Medical Director, Global Evidence Generation Lead

The medical Director, evidence generation is responsible for supporting strategi...

Location

Belgium , Mechelen

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum of 7+ years of experience in evidence generation, clinical development, HEOR, or a related field
At least 5 years of experience in Epidemiology, Health Economics Outcomes Research (HEOR), or/and Health Systems Research
Proven track record of developing and implementing integrated evidence generation plans in the pharmaceutical or biotechnology industry
Experience in design, conduct and oversight of real-world evidence studies ranging from protocol writing to project management oversight and data interpretation and communication
Solid understanding of the cross functional drug development lifecycle and processes (Business Development, clinical trial design, conduct, & endpoint selection, Clinical Operations, Data Management, Biostatistics, and Regulatory)
Demonstrated expertise and experience working with methods for evidence generation using primary and secondary data sources, knowledge of common issues and challenges of implementation, and track-record of successful publications
Demonstrated depth of understanding of observational research methods, regulatory standards, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
Evidence of technical expertise of applying pharmacoepidemiology evidence and insights at the therapy/product level
Ability to explain strengths and limitations of clinical practice datasets — such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources — in context of designing pharmacoepidemiology study designs
Ability to work successfully in a matrix and quick paced environment

Job Responsibility

Collaborate with cross-functional colleagues to Lead the development and execution of Medical evidence generation strategy and tactics supporting products in development as well as those commercially available, with appropriate prioritization and use of resources ensuring alignment with corporate goals, regional needs, and therapeutic priorities
Oversee the Design and implementation of Integrated Evidence Generation Plans (IEGPs) that incorporate clinical, real-world, and economic data to support product positioning and value demonstration
Scope RWE studies (Regional/National/Academic/Patient/Vendor), selection of new or existing academic (can include: ISR/lIS/NIS)/non-governmental registries (retrospective/prospective), management across various phases from start up, maintenance to final deliverables
Translate (early) trial efficacy to real-world comparative effectiveness as part of early and late phase study planning, identification of subpopulations, and for potential risk-sharing purposes
Design and implement multiple database and/or de novo (e.g. registries) pharmacoepidemiologic studies, as well as literature reviews, intended to provide insight into background epidemiology, disease state regular care, and/or quantify benefits and/or risks potentially associated with Alfasigma products
Project management oversight – ensuring effective design, initiation and implementation of real world evidence studies, while ensuring effective study protocols and plans, managing budget and milestone tracking, and where appropriate contracting with partner organizations
keep abreast on new data and developments in the field, key publications of interest, research methodologies and regulatory standards across the EU and New Markets regions and proactively address HOR strategy changes in collaboration with global and regional teams in anticipation of any trends
Review and provide relevant RWE/HOR inputs to statistical analysis plans and analysis outputs
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
Establish metrics to evaluate the effectiveness and impact of evidence generation activities on corporate and product-specific objectives

What we offer

We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development

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

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Early Development Clinical Research Associate

Job Description

Job Responsibility

Requirements

What we offer

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