This is a Part-time position for 20 hours.
The Senior Clinical Data Manager will serve in a support-level capacity on a Clinical Data Management team to provide efficient and quality clinical data management products.
What you will be doing: Support the design, specifications, and development of eCRFs, ensuring adherence to Biogen standards throughout.
Coordinate the development and testing of clinical data management systems edit checks and listings/reports/tools for data review and discrepancy management activities.
Support the development of Data Management Plan documents that will ensure delivery of accurate, timely, consistent, and high-quality clinical data.
Works with Third Party /External data Vendors to complete the set-up of data import and reconciliation processes.
Perform comprehensive review of all data generated from the clinical study including Third Party/External data, SAE data and local lab data, as applicable.
Oversees quality control procedures.
Develop and maintain strong communications and working relationships with CDM team.
With guidance from Principal Clinical Data Lead or Manager, effectively manage project timelines and quality.
Provide reports, status updates, feedback, and advice to key study stakeholders on the progress of data cleaning and risk identification/mitigation activities.
Ensure CDM activities are performed in compliance with Good Clinical Practice, ICH Guidelines, Biogen SOPs, Job Aids, regulatory guidelines, and study specific plans.
Apply appropriate best practices and independently offer project solutions to the study team.
Ensures activities that are performed are done in line with study timelines, with quality and in compliance with governing process.
Support the filing of eTMF documentation to ensure that an inspection ready environment is maintained throughout the study lifecycle.
Supports and assists Subordinate staff for assigned trials.
Impacts quality, timeliness, and effectiveness of the team.
Provide back up support for Principal Clinical Data Lead as required.
You are: 4+ years of Clinical Data Management experience Ability to work under pressure demonstrating agility through effective and innovative team leadership Robust experience with EDC (E.g.
Medidata Rave) and use of Data Review tools such as elluminate, J-Review or Business Objects required Deep understanding of drug development and biopharmaceutical industry required Strong technical skills, including experience working with using Microsoft Excel functionality Fluent English (oral and written) Strong understanding of drug development and biopharmaceutical industry required High attention to detail including proven ability to manage multiple, competing priorities Excellent written and oral communication skills Bachelor's degree preferred, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, 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 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.
https://careers.iconplc.com/reasonable-accommodations 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.