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

Doctorate degree OR Master’s degree & 2 years of clinical trial experience or equivalent OR Bachelor’s degree & 4 years of clinical trial experience or equivalent OR Associate’s degree & 8 years of clinical trial experience or equivalent OR High school diploma / GED & 10 years of clinical trial experience or equivalent
5 years’ work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience working in clinical trial operations as a Clinical Research Associate
Experience in authoring ICF forms preferred
Experience in a clinical setting e.g. clinical site role may be an advantage.

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Informed Consent Manager

Key skills