Clinical Data Science Lead

Overview

As a Global Data Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will provide data management oversight and accountability for one or more clinical trials.

Responsibilities

What you will be doing:

Takes a leadership role with the CRO, 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, CRO and other functional partners: – Gathers content and integration requirements for eCRF and other data collection tools. – Establishes conventions and quality expectations for clinical data. – 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 described in the oversight plan, QC process and work instructions with minimal DML direction.

Reviews 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 matrix.

Ensures real-time inspection readiness of all Data Management deliverables for the trial; Participate in Regulatory Agency and internal audits as necessary.

Plans and tracks content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time.

Takes a leadership role with the assigned clinical working group(s) to ensure that Data Management and TA trial needs and deliverables are met.

Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.

Presents and trains at investigator and monitor meetings if needed

Qualifications

You are:

 

Bachelor’s degree or equivalent in Health or Science discipline, with experience in clinical research, desired.

Minimum of 5 years of Data Management experience (start-up to lock).

Clinical trials experience is required. Experience managing multiples studies at once with experience managing competing priorities is needed.

Oncology experience is helpful. But, not required.

Experience working in highly diverse teams within clinical research; cross-functional, global, multi-regional.

Project management skills. Must have prior experience creating timelines and managing deliverables.

Vendor management skills.

Advanced Microsoft Office skills including the ability to manipulate and analyze data.

Must have experience reviewing SAS and SDTM datasets.

Experience with RAVE is highly desired.

Highly organized with excellent written and verbal communication.  Must have experience presenting during kick-off meetings, investigator meetings, and study team meetings.

Ability to interpret clinical trial data and present trends to clinical trial team on data.

Very minimal, if any, travel is expected. Possibly for investigator and/or kick-off meetings.

 

 

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, 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 w