ICON Strategic Solutions Data Management Trial Manager - Remote Based in US in Boston, Massachusetts
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.
As a Principal Lead Clinical Data Manager, you will oversee the data management strategy and project plans for collection and integration of all clinical data including but not limited to, case report forms (CRF) data, lab data, biomarker data, and patient reported outcomes for one or more trials within a specific drug program. You will lead cross-functional, global teams to ensure all aspects of the project plan (from data management trial planning through submission components) are executed on time and with appropriate quality. You will serve as a project manager for data management activities and represent global data management for assigned trials.
What do you need to have?
Education : Bachelor’s degree preferred
Experience : 7 years of data management experience preferred
Manage all operational aspects of clinical trials in compliance with GCP regulations, ICON policy and Client Company policy.
Manage project and timelines across Client programs and studies.
Ensure timeliness of deliverables for each phase of the study from study start-up through production and close-out activities.
Interact with various Data Management and other functional area colleagues, including, but not limited to: Biostatistics and Programming, Clinical, Safety, Medical Coding, site personnel.
Ensure Clinical Data Management staff maintains all relevant documentation associated with each assigned Protocol.
Identify and work collaboratively and cross-functionally to implement process improvement measures within data management on both departmental and project level.
Coordinate with Clinical Data Management Staff, Client, and Study Team to identify issues/trends for discussion.
Lead study/project team meetings as primary facilitator of timelines, providing updates on study status to the cross functional team.
Escalate any potential or actual issues in a timely manner and follow issues through to resolution.
Contribute to the development and/or revision of Clinical Data Management SOPs and related documentation.
Serve as primary point of contact for all project timeline related communication.
Monitor and work to maintain/improve stakeholder satisfaction by ensuring high quality service, communication, and management of clinical data.
Lead and facilitate all project team meetings.
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.
ICON Strategic Solutions
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