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;
- 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.
- Sets 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 J&J 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.
You possess;
- Minimum of 5 years of Data Management experience in Clinical Trials (start-up to database lock).
- Experience managing multiples studies at once / while managing competing priorities
- Experience working in highly diverse (cross-functional, global, multi-regional) teams within a clinical research setting
- Project management skills / experience; Must have prior experience creating timelines and managing deliverables
- Ability to interpret clinical trial data and present trends to clinical trial team(s)
- Experience presenting at/during kick-off meetings, investigator meetings, and study team meetings
- Vendor management skills / experience
- Microsoft Office skills, including the ability to manipulate and analyze data
- Experience reviewing SAS and SDTM datasets
- Strong organizational and written / verbal communication skills
PREFERRED:
- Bachelor’s degree or equivalent in a Health or Science discipline, with experience in clinical research highly desired.
- Oncology therapeutic experience desired.
- Experience working with Medidata RAVE.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
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, 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.
#MB-LI1
.jpg)
.png)
