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ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Services Overview:

The CDM will perform scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).

What you will be doing:

• Involved in study related activities from the protocol design stage onwards, providing input into the study specific and/or indication specific data collection tools.
• Reviews (complex) scientific study data, manages CDM and SRS/SRP related queries in eDC system and holds discussions with SRS/SRP. Involvement in other review activities (e.g., Coding, SAE reconciliation) is possible. Leads and/or attends meetings as appropriate.
• Takes a leadership role with SRP/SRS and collaborates with the GDM to establish, align and confirm scientific clinical data review expectations for assigned trial(s).
• With the trial customer, CRO and other functional partners in relation to CDM related activities:
  • Reviews content and integration requirements for eCRF and other data collection tools.
  • Establishes conventions and quality expectations for clinical data.
  • Set timelines and follow‐up regularly to ensure delivery of all Clinical Data Management milestones.
• Creates the Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Reviews related clinical data management documents. Ensures compliance with regulatory guidelines and documentation requirements.
• Ensures real‐time inspection readiness of all assigned deliverables for the trial; participate in Regulatory Agency inspection and client internal audits as necessary.
• Plans and tracks applicable CDM deliverables. Ensures CDM deliverables are on time.
• Takes a leadership role in collaborating with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are met.
• Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.
• Identifies and participates in process, system, and tool improvement initiatives within clinical data management.
• Program-level leadership role in support of the Data Management Leader (DML) by taking on clinical data management responsibilities.
• Ensures that clinical data management documents are reviewed accurately to facilitate appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency at the program level. Ensures compliance with regulatory guidelines and the documentation matrix at the program level.
• Collaborates with the DML and the DMTA Head(s) to distribute work assignments and identify needed resources.
• Takes a leadership role to obtain, share, and develop best practices with internal and external partners.
• Leads others in developing and implementing process, system, and tool improvement initiatives within clinical data management.

You possess:

• BS/BA degree or higher preferably in Health Sciences, or BS/BA degree or higher with professional clinical experience/exposure.
• Oncology therapeutic area exposure.
• 5 years Data management experience. Leadership experience.
• Data Management experience preferably including clinical data review or significant experience with clinical data review. Knowledge in medical terminology would be preferable.
• Collaboration with Clinical teams.
• Experience in clinical drug development within the pharmaceutical industry or related industry.

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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