Job Details
Exciting Manager/Lead of Clinical Data Management openings with one of the world's largest and most reputable Clinical Research Organizations in ICON PLC.
Responsibilities: 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.
Qualifications:
- Education: Bachelor s degree preferred
- Experience: 7 years of data management experience preferred
- Skills:
- 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.
At 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 work we ve done to become a more inclusive organisation. 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, 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 through the form below.