Informed Consent Manager Job at Amgen

Informed Consent Manager

In this vital role you will help bring innovative medicines to patients by deliv...

Location

United Kingdom , Uxbridge; London

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Clinical trial execution experience
Experience working within a global team structure
Project management experience
Previous experience in life sciences or a related field, including biopharmaceutical clinical research
Experience in authoring ICF forms
Experience in a clinical setting e.g. clinical site role is preferred

Job Responsibility

Manage the end-to-end delivery of study-specific informed consent forms (ICFs), ensuring they are high quality, compliant, and delivered on time
Review, edit, and contribute directly to ICF content to ensure accurate alignment with study protocols and regulatory requirements
Work day-to-day with Study Delivery Teams and ICF Authors to develop ICFs that meet study timelines and operational needs
Perform quality checks on all study-level ICFs, resolving issues quickly to maintain speed and consistency
Partner with Patient Engagement teams to incorporate patient feedback and improve clarity, accessibility, and usability of ICFs
Coordinate ICF translations, version control, and country-specific updates to support global study execution
Maintain and actively manage study ICF tracking, reconciliation, and status reporting across studies
Identify and implement practical improvements to ICF processes, tools, and ways of working to improve delivery performance

What we offer

Vast opportunities to learn and move up and across 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

Senior Manager Informed Consent

Shape how patients around the world understand and engage with clinical research...

Location

United Kingdom , Uxbridge; London; Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Clinical trial execution experience
Previous people leadership managing teams, projects, or resources
Previous experience in life sciences including managing data on biopharmaceutical clinical research experience
Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
Experience with managing data collection and oversight with external vendor (CROs, central labs, imaging vendors, etc.)
Experience in roles that include patient centricity and/or Informed Consent Development and oversight

Job Responsibility

Lead and develop a high-performing global Informed Consent Form (ICF) team
Own the end-to-end ICF development process, driving continuous improvement in quality, speed, and standardisation
Provide strategic and operational leadership for ICF planning, resourcing, and execution across the pipeline
Ensure compliance with global and country-specific regulatory requirements and inspection readiness
Partner cross-functionally to deliver patient-centric, clear, and consistent informed consent content
Monitor performance metrics, trends, and inspection findings to drive data-led improvements
Act as a change leader, strengthening collaboration, accountability, and clarity of roles across stakeholders
Line manage and mentor ICF managers, building capability, engagement, and a culture of excellence

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Oncology Research Nursing Professional (RN), South Bay Cancer Center

A Brief Overview The Oncology Research Nursing Professional (ORNP) –is a Registe...

Location

United States , SAN JOSE

Salary:

83.98 - 111.27 USD / Hour

Stanford Health Care

Expiration Date

Until further notice

Requirements

BSN or higher-level nursing degree required
MSN highly preferred
Masters in research or healthcare related field preferred
5 plus years nursing experience required -OR- 3+ years in an oncology research nurse role required
2 or more years of experience in oncology
Experience in clinical research, research, ICU, other intensive care setting, pediatrics, case management or nurse navigation preferred
Human subjects’ protection and Good Clinical Practices training (can be completed after hire)
Ability to communicate vetted information at all levels of the organization and with internal/external vendors
Ability to be highly- and multi- task focused while managing multiple tasks and projects simultaneously across various platforms
Ability to understand information flow and solve problems under pressure

Job Responsibility

Clinical Trial Management
Informed Consent Process
Protocol Compliance
Other

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
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

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
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
Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
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
Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project
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)
401(k) Retirement Savings Plan (RSP)
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 Associate

Location

United States , Houston

Salary:

Not provided

Establishment Labs

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field such as life sciences, engineering, pharmacy, business, clinical research, or a related discipline
Good Clinical Practices certification
Knowledge in Systematic literature search Zotero/Mendeley
Medical Device Regulation
Advanced English C1 scored
7+ years of experience on similar roles
Microsoft Office suite (Word, Excel, PowerPoint, Planner, etc.)

Job Responsibility

Coordinate and oversee clinical trial activities throughout the study lifecycle
Provide strategic guidance and oversight, mentoring junior staff and coordinating with management
Develop and maintain clinical trial documentation
Advanced clinical support, including document creation for product registration and statistical analysis of clinical trials
Create, implement and administer methods and procedures to enhance operations, as appropriate
Provide clinical feedback and knowledge to Regulatory Affairs in the creation of documents required for products registration and technical file (Clinical Evaluation Report)
Oversee clinical trial operations and site performance
Clinical trials reports creation
Submission package readiness for Ethics Committees approval
including clinical protocols, design case report forms, patient and investigator brochure, informed consent form, among others

Fulltime

Clinical Project Manager - Maternity Cover

Are you ready to pursue your career within disruptive MedTech working with 3D sc...

Location

Denmark , Copenhagen

Salary:

Not provided

3Shape

Expiration Date

Until further notice

Requirements

Master's degree within a scientific field, preferably a PhD degree
Experience with managing clinical studies within the medical device industry
Strong knowledge of EU MDR, ISO 14155, and Good Clinical Practice (GCP)
Relevant clinical operation and medical/scientific writing experience in the medical device settings
Experience with post-market clinical follow-up (PMCF)
Strong organizational and communication skills, ability to manage multiple projects simultaneously
Fluent in written and oral English
Good team player with strong interpersonal skills
Ability to handle multiple tasks while managing tight deadlines

Job Responsibility

Lead the planning, execution, and delivery of pre- and post-market clinical investigations including post-market clinical follow-up in accordance with applicable regulations (e.g., MDR, ISO 14155, GCP)
Be responsible of clinical investigations documentation (clinical study protocols, informed consent form, patient information sheet, study contracts, application to relevant authorities, study reports and scientific publications)
Manage study timelines, budgets, and resources to ensure successful project delivery
Provide support regarding clinical investigation methodology (sample sizes, endpoints, analyses/statistics)
Ensure compliance with regulatory and ethical standards
Collaborate closely with internal stakeholders (Regulatory, Product Creation, Product Management, Marketing, Legal) and external partners (CROs, clinical sites)
Support the organization during internal and external audits
Provide input to PMCF, Post Market Surveillance (PMS), and vigilance activities based on e.g., risk management, input from customer and complaints
Provide support to Regulatory Affairs, Product Creation, Product Management, and other 3Shape functions as required
Contribute to continuous improvement of processes regarding clinical evidence, clinical operations and PMS based on knowledge of applicable regulations, guidance’s, and best practices

What we offer

Vibrant and international environment with social, diverse, and highly skilled and cooperative colleagues
Attractive healthcare package
Breakfast every day
Delicious and healthy lunch cooked by private chefs
Great social work environment with many optional activities and social clubs
Good work/life balance
Attractive offices and R&D lab spaces in downtown Copenhagen close to Kgs. Nytorv, Nyhavn, and the Copenhagen Canals
Purpose: Help improve dental care on a global scale

Fulltime

Conflicts Analyst

Beacon Hill Legal is seeking a Part-Time Conflicts Analyst to support our client...

Location

United States , Atlanta

Salary:

30.00 USD / Hour

Beacon Hill

Expiration Date

Until further notice

Requirements

Prior experience handling lateral conflicts within a law firm environment required
Strong attention to detail and ability to manage sensitive information
Experience with conflicts systems (Upfront preferred) and legal research tools

Job Responsibility

Manage and facilitate lateral conflicts review, partnering with candidates, attorneys, recruiting, and administrative teams to ensure complete and accurate due diligence
Create, review, and analyze conflicts reports using firm systems (including Upfront)
Review lateral candidate materials, including client/matter lists, questionnaires, and portable business information to identify potential conflicts
Track and manage waivers, consents, engagement letters, and ethical screens
Monitor and follow up on pending conflicts requests to ensure timely resolution
Maintain and update conflicts databases, ensuring accuracy of party information and matter histories
Support implementation of ethical walls, confidentiality screens, and related compliance measures
Conduct research using tools such as Lexis, public records, and corporate family tree resources to validate parties and identify related entities

Parttime

Real Estate Paralegal

Robert Half Legal is working with an innovative private lending company that par...

Location

United States , Encino

Salary:

45.00 - 55.00 USD / Hour

Robert Half

Expiration Date

Until further notice

Requirements

Strong understanding of LLCs, corporations, partnerships, and trusts
Experience with entity due diligence and deficiency reporting
Familiarity with real estate loan documents and closing processes
Excellent attention to detail and strong organizational skills
Ability to work independently in a high-volume environment
Proficiency with Microsoft Office and document management systems

Job Responsibility

Review entity documents, including formation and governance records
Confirm signing authority through resolutions, consents, and related authorizing documents
Spot missing documents, inconsistencies, and due diligence issues
Obtain and review good standing and business status documents in multiple states
Prepare summaries, checklists, and transaction trackers
Review loan packages for accuracy, completeness, and consistency
QC key documents such as notes, deeds of trust, loan agreements, guaranties, and security documents
Compare final documents against approved deal terms and closing requirements
Review property details, including legal descriptions and parcel information
Track documents through execution, closing, and recordation

What we offer

medical, vision, dental, and life and disability insurance
401(k) plan

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Informed Consent Manager

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