Informed Consent Manager Job at Amgen

Compliance Analyst

insightsoftware is seeking a detail-oriented and proactive Compliance Analyst to...

Location

United States , Remote

Salary:

Not provided

insightsoftware

Expiration Date

Until further notice

Requirements

Bachelor's degree in information security, Cybersecurity, Computer Science, Risk Management, Legal Studies, Business Administration, or related field
Minimum 3+ years of experience in compliance program management, risk management, or information security roles, preferably in regulated industries or technology companies
Demonstrated experience responding to third-party risk assessments, security audits, customer security questionnaires, RFPs, and compliance due diligence requests
Working knowledge of regulatory frameworks and standards (e.g., ISO 27001, SOC 2 (Type II), NIST, FedRAMP, CMMC, PCI DSS, GDPR, CCPA), trade control regulations (EAR, ITAR), anti-bribery/corruption laws (FCPA, UK Bribery Act), and data privacy principles
A strong knowledge of at least one regulatory framework governing matters pertaining to data privacy, cybersecurity, trade compliance, or third-party risk management
Experience with third-party screening tools and vendor risk management platforms
Familiarity with GRC or data protection management platforms (e.g., OneTrust, ServiceNowMetricStream)

Job Responsibility

Support the development, implementation, and maintenance of a global compliance program, including trade compliance, anti-bribery/corruption, anti-trust, and business ethics
Conduct secondary screening of third parties (vendors, partners, customers) , and assess potential matches against government watchlists of denied, debarred, sanctioned, or restricted parties to ensure compliance with applicable trade compliance, export control and sanctions regulations (e.g., U.S. Department of the Treasury Office of Foreign Assets Control ("OFAC"), U.S. Department of Commerce Bureau of Industry and Security ("BIS"), U.K. Office of Financial Sanctions Implementation ("OFSI"), European Union, and United Nations)
Assist with export classification determinations and licensing requirements for software products and services, including evaluation of Export Control Classification Numbers ("ECCNs")
Support the company's compliance with applicable data protection regulatory frameworks (e.g., GDPR, CCPA)
Support the Corporate Counsel, Data Privacy, AI, Cybersecurity with data protection initiatives and obligations including data mapping exercises, processing activity records, and privacy impact assessments, and coordinate responses to data subject access requests ("DSARs") and privacy-related inquiries
Support privacy management tools and platforms for consent management and privacy workflow automation
Partner with company counsel, InfoSec, and other stakeholders with compliance audits, data privacy questionnaires, and third-party risk assessment processes including vendor due diligence and ongoing monitoring
Support risk and control self-assessments ("RCSA"), audit management, and remediation tracking
Collaborate with stakeholders including the Chief Information Security Officer ("CISO") and the team to quantify, monitor, and report on security and compliance performance
Maintain GRC platforms (e.g., ServiceNow, Archer, MetricStream) to track compliance activities, risks, and controls

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Senior Manager Informed Consent

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

Location

United States

Salary:

184527.00 - 212393.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of clinical execution experience
Master’s degree and 6 years of clinical execution experience
Bachelor’s degree and 8 years of clinical execution experience
Associate’s degree and 10 years of clinical execution experience
High school diploma / GED and 12 years of clinical execution experience
Minimum of 2 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead and develop a high-performing global Informed Consent Form (ICF) team, ensuring high quality, compliance, and timely delivery across all portfolios
Own the end-to-end ICF development process, driving continuous improvement in quality, speed, and standardization
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

Total Rewards Plan
Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements

Fulltime

New

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

Biomarker Consent Specialist

Join Parexel’s team of changemakers as we help advance healthcare throughout the...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Exceptional communicator to partner effectively with internal and external teams
Self‑motivated professional who can work independently and collaboratively
Critical thinker able utilize and discern guidance documents as they apply to clinical trial informed consents
Proactive problem solver to identify issues, propose solutions, and drive resolution
Detail oriented individual with the ability to manage multiple assignments under accelerated timelines
Quick learner who can become proficient in client tools, databases, and systems
Proficient MS Office Suite user
Bachelor’s degree (BA/BS) required
Minimum of 5 years of experience working with global clinical trials and associated systems (eTMF, LIMS, or similar) AND proven experience with genetic informed consents and global consent negotiation

Job Responsibility

Author, review, and negotiate genetic and biomarker language within clinical trial informed consent documents
Document restrictions related to genetic and biomarker research on clinical trial samples
Understand and apply company policies and procedures to ensure consistency and compliance in informed consent language
Collaborate with global stakeholders to negotiate informed consents across multiple regions
Utilize clinical trial systems (eTMF, LIMS, etc.) to support documentation and workflow needs
Manage multiple concurrent assignments while meeting accelerated project timelines
Provide clear communication and partnership to cross‑functional teams to achieve study and organizational goals

What we offer

Health, Vision & Dental Insurance
Tuition Reimbursement
Vacation/Holiday/Sick Time
Flexible Spending & Health Savings Accounts
Work/Life Balance
401(k) with Company match
Pet Insurance
Flexible working hours
Professional growth and development opportunities

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