Lead Data Manager (Sponsor Dedicated)

Overview

As a Lead Global Data Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

Oversees and coordinates Data Management activities across one or more clinical trials. Develop and maintain successful working relationships with internal team and internal and external stakeholders to ensure and maintain data integrity and quality.

Services rendered will adhere to applicable client SOPs, WIs, policies, local regulatory requirements, etc.

What you will be doing:

• Provides data management support, oversight and/or accountability for one or more clinical trials.
• May take a leadership role with the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s).
• With the trial customer and other functional partners: – Gathers content and integration requirements for eCRF and other data collection tools. – Establishes conventions and quality expectations for clinical – Establishes expectations for dataset content and structure. – Set timelines and follow-up regularly to ensure delivery of all Data Management milestones.
• Performs trial level oversight controls, as appropriate, as described in the oversight plan, QC process and work instructions with minimal DML
• Creates clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensures compliance with regulatory guidelines and the documentation
• Ensures real-time inspection readiness of all Data Management deliverables for the trial; Participate in Regulatory Agency and sponsor internal audits, as
• Helps plan, create and track content, format, quality, and timing of data management deliverables, including, but not limited to, Case Report Form, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival.
• Ensures deliverables are on
• Participates in the assigned clinical working group(s) to ensure that Data Management and Therapeutic Area trial needs and deliverables are
• Helps Identify and communicate lessons learned, best practices and frequently asked questions at the trial
• Presents and trains at investigator and monitor meetings, if needed

Qualifications

You possess:

• Bachelor’s degree in Health or Science discipline with experience in clinical research
• Data Management experience preferred / required for base and advanced level
• Experience working on a clinical trial
• Experience working in highly diverse teams within clinical research; cross-functional, global, multi-regional
• Project management skills
• Vendor management skills
• Advanced Microsoft Office skills including the ability to manipulate and analyze data
• Highly organized with excellent written and verbal communication
• Ability to interpret clinical trial data and present trends to clinical trial team on data

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/benefitsAt 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, colour, 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-accommodationsInterested 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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