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.
What you will be doing:
- Ensuring clinical projects are executed according to set timelines with quality and consistency
- Leading DM activities for a given product or multiple products
- Ensuring that DM procedures and processes are adhered to by FSP staff through oversight of quality, cycle times, metrics and use of the Issue CAPA process
- Co-ordination and mentoring of lead data managers within assigned projects
Key Activities:
- Training and mentoring of DM TA staff on processes, projects and programs
- Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM
- Participate in and/or lead DM and cross functional working groups
- Contribute to the continuous improvement of DM and the wider Development organization through information sharing, training and education
- Contribute to development of DM outsourcing strategies and long-term relationships with CRO partners / external vendors
- Oversight of FSP vendors with respect to quality, Issue & CAPA tracker & KPI metrics
- Promote and be an advocate of DM internally and externally
- Represent DM at project team meetings i.e., GCST
- Project level coordination of and day to day oversight of DM tasks including:
- Co-ordination of lead DM’s within the project
- Review of all DM documents within a project area to ensure a consistent approach
- Overview of project timelines and metrics to ensure databases are delivered to set timelines
- Approve database locks and unlocks
- Actively monitor progress of clinical projects within assigned product area to ensure delivery to set timelines and quality standards
- Provide DM product level input to developing and managing resource plans and budgets for DM
- Ensure that quality control checks are occurring such that quality databases are delivered
- Develop and co-ordinate project level training for data management staff
- Review and approve study specific training
- Manage vendor deliverables and relationship at the project level
- Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.
- Review of all study level non DM documents for awareness and project level consistency
- Lead electronic submission activities
- Assist with response to questions and findings from Clinical Quality
- Assurance (Quality Assurance) and other audits at the study / vendor level coordination of and day to day oversight of DM tasks
You possess:
Basic qualifications
- Doctorate degree OR Master’s degree & 3 years of clinical experience OR
- Bachelor’s degree & 5 years of clinical experience OR
- Associate’s degree & 10 years of clinical experience OR
- High school diploma / GED & 12 years of clinical experience
Preferred Qualifications
- Bachelors degree or equivalent in life science, computer science, business administration or related discipline
- 6+ years work experience in data management in the Pharmaceutical or Biotech arena
- 3+ years project management and planning experience
- Experience in oversight of outside vendors (CROs, central labs, imaging vendors, etc.)
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
ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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 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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