ICF Manager

ICF Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

ICF Manager

As a Medical Affairs Coordinator, working as an ICF Manager, exclusively assigned and embedded within a Pharmaceutical Company, you will:

Be responsible for the end-to-end development and management of Master Informed Consent Forms (ICFs) for clinical trials. This role drives the implementation of ICF processes to improve quality, reduce turnaround time, and enhance compliance with global regulatory expectations. 
In close collaboration with the Clinical Study Manager (CSM), Study Start Up (SSU) Manager, CRO and pertinent functional stakeholders:
•    Develop Master ICFs and amendments in concordance with the study protocol and schedule of events and file in the TMF.
•    Support country and site-specific reviews.
•    Facilitate ICF review with oversight by the CSM (who will provide study-specific guidance).
Serve as Subject Matter Expert (SME) in study level ICF development and partner with Process Optimization stakeholders to identify process improvements and keep teams informed.
 

ACCOUNTABILITIES: 

• Provides subject matter expertise and operational input into creating and finalizing ICFs using Company template, processes and systems.

• Coordinate and Lead ICF Kick-off Meetings.

• Attend and actively participate in Study Execution Team (SET) meetings related to ICF development and amendments.

• Prepare study level Master ICFs from draft through final approval in collaboration with CSM, SSU Manager, CRO and other functional stakeholders and file in TMF.

• Support country and site-specific ICF reviews.

• Coordinate ICF review and revisions following regulatory agency inquiries.

• Manage ICF amendments and coordinate review, approval and filing.

• Coordinate reviews by functional stakeholders and ensure all pertinent reviews are completed prior to ICF approval.

• Support BPO in updating the centralized language library by identifying gaps and aiding in addressing them.

• Review protocols and schedules of events to ensure accurate and compliant ICF content.

• Support process improvement initiatives, including creating onboarding materials and leading training sessions for ICF related topics.

• Serve as a subject matter expert for ICF-related processes, systems and workflows.

• Support in follow-up to audit findings and CAPAs concerning ICFs.

• During periods of reduced workload on ICF tasks, provide support to the Clinical Study Manager (CSM) with study-related activities, including but not limited to:

  • Periodic trial master file (TMF) review

  • Collect/review/File study documents in support of the TMF

  • Collect/review/File study documents in support of the regulatory filing

  • Support country and site feasibility/selection process during startup

  • Support drafting and review of relevant study plans

  • Support review of trial operational data (e.g., CTMS)

  • Support data review for database lock and CSR writing and review (including appendices)

  • Review monitoring visit reports (with training) and support pertinent issue escalation and resolution (with tracking and documentation)

  • Support sample reconciliation and disposition

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

Education: Bachelor’s Degree or international equivalent required; Life Sciences preferred.

Skills: 

• Understand how to read study protocols and schedule of assessments and develop an ICF

• Excellent teamwork, organizational, interpersonal, and problem-solving skills, including experience with Leading cross-functional teams, vendor selection and oversight

• Proficiency in Microsoft Office Suite and document management systems

• Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is a plus.

• Demonstrated successful experience in project/program management and matrix leadership (E.g., Risk identification and management)

• Works independently and is highly organized

• Fluent business English (oral and written)

Experience:

• 4+ years in the pharmaceutical industry and/or clinical research organization.

• 2+ years of experience in study start-up and ICF development.

• Experience with drafting and managing ICF processes at both site and CRO/sponsor levels.

• Clinical background as an RN (Registered Nurse) is a plus, especially with direct involvement in patient-facing documentation and clinical trial operations.

• Familiarity with Veeva is a plus.

Advanced degree(s) (e.g., RN, Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements.

TRAVEL REQUIREMENTS:

• Requires approximately 5-10% travel, including overnight and international travel to Company sites.

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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