Independent Drug Monitoring 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.

What you will be doing:

• • Comply with relevant and on‐time training requirements.
  • Lead study teams in management of IDM related processes and operations; ensuring blind.
  • Provide input for the development of pharmacy related materials, including forms and manuals.
  • System set‐up including IVRS and EDC in a supportive capacity.
  • Ensure adherence to quality of the IDM process, including, translation, documentation, and escalation of major/critical issues in a blinded manner; follow up appropriately to closure.
  • Act as the main point of contact for resolution of any ad‐hoc questions associated with IDM issues.
  • Resolve and document urgent/critical unblinded and pharmacy‐related issues and investigate trends.
  • Monitor status and resolution of major/critical issues via Issue Logs and Visit Report review process.
  • Provide updates to Trial Team on pharmacy‐related and compliance issues in a blinded fashion.
  • Take initiative to suggest and implement solutions to site‐level issues.
  • Oversees Independent Drug Monitors (IDMs) to ensure investigational product activities are addressed at sites. Primary point of contact for the IDM.
  • Provide communications and necessary information to IDMs on study updates, such as protocol amendments Potential of to co‐monitor IDMs.
  • Review IDM monitoring visit reports (initiation, periodic & close‐out) and provide feedback, as needed.
  • Provide back‐up and support for the IDM.
  • Provide training & re‐training to new IDMs and site pharmacy staff.
  • Ensures IDM visits occur within window and ensure any out of window visits are tracked per process.
  • Ensures IDM monitoring visit reports and issue logs are up‐to‐date
  • Ensure existence and accuracy of relevant IDM process documentation, communication and monitoring plans.
  • Provide input in audits and/or CAPAs.
  • Assist in database lock/interim analysis; cleaning unblinded data and reviewing unblinded queries, if applicable.
  • Create appropriate trial‐specific IDM training materials and requirements.
  • Establish and maintain excellent working relationships with internal and external stakeholders.
  • Maintain Blinded TMF and perform document management activities.
  • Provide feedback to and train/coach/guide junior colleagues as needed.
  • Work proactively to increase global awareness of IDM processes; train and educate
  • Comply with relevant and on‐time training requirements.
  • Contribute to IDM process improvement and training, as applicable.
  • Lead and/or participate in special initiatives, task forces or non‐trial project work, as assigned; typically, in Advanced.
  • Advanced services:
    • Coach and/or mentor less experienced IDMMs.
    • Assigned more complex projects and/or assignments that have a greater potential
      impact on business results.
    • Autonomy in role.
    • Depth of knowledge of IDMM services.

You are:

• Bachelor’s or University degree; or equivalent, in appropriate scientific or business discipline.
• 3‐5 years of relevant experience in clinical trial operations in the pharmaceutical industry or CRO. Advanced: 5+ of relevant experience in clinical trial operations in the pharmaceutical industry or CRO required; advanced degree.
• Experience in Project Management mandatory; knowledge of databases and/or project management systems.
• Previous work in an international environment.
• Experience working within Unblided stduies and within IP
• Strong working knowledge of ICH‐GCP, local laws and regulations.
• Effective leadership skills and ability to manage multiple stakeholders.
• Experience and ability in coordinating teams in a virtual environment.
• Proven ability to foster team productivity and cohesiveness.
• Independent complex decision making.
• Solution oriented and proactive risk identification and mitigation.
• Strong IT skills, including knowledge of standard Industry systems and Microsoft applications; willingness to learn new systems.
• Monitoring experience is recommended; other relevant experience should be considered.
• Willingness to travel locally/domestically.
• Proficient in speaking and writing local country language and English.
• Effective verbal and written communication skills.
• Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available.
• Experience in developing presentations and presenting key information to stakeholders.

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 maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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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