Principal Clinical Data Science Lead (Sponsor Dedicated)

As a Principal Clinical Data Science Lead you will be joining the worlds largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

• What you will be doing:
• Supervisory position managing activities of Data Management staff assigned to specific protocols
• Serve as an experienced knowledge resource for all members of global cross-functional study team and provide assistance, mentoring, and/or training to Data Management colleague
• Implement education/ training programs for Data Management staff to promote understanding, quality output, and productivity
• Monitor and work to maintain/improve study team satisfaction by ensuring high quality service, communication, and management of clinical data
• Management as necessary to meet the needs of the business and global study team
• Assume operational responsibility for Clinical Data Management (CDM) related tasks
• Document all activities adequately in the course of the study
• Specify and / or develop study specific data components (study metadata), interact with the EDC developer in the specification and design of eCRFs and database structures
• Specify study specific data consistency checks (edit checks) in the Data Validation Document
• Contribute to the DM part of EDC UAT
• Perform consistency check for external data
• Request and coordinate the SAS-programming of edit checks and derivations
• Identify and issue queries, incorporate query replies, track query status
• Contribute to the preparation of data monitoring
• Prepare data listings or data extracts for medical reviews and reports specifically
• Provide the protocol deviation document for all assigned studies in cooperation with the study team
• Prepare a database closure plan, communicate plan within the study team, conduct the database-closure activities
• Identification and communication of issues which have the potential to affect timelines or data

You are:

• Bachelors degree (or equivalent) in Natural Sciences, Informatics or Medical Documentation.
• 7+ years of experience as Lead Clinical Data Manager in projects and study teams, with a comparable area of responsibility as requested in this SSD.
• Experience with training and/or mentoring more junior level Data Management staff
• Ability to serve as a primary resource for all study related personnel and act as an escalation point for less experienced Data Management staff
• Proven effective self-management and organizational skills, ability to work self-organized and independently
• Good project management skills
• Solid experience as player in global, cross functional teams, including ability to lead such teams towards a given goal (e.g., goals like “DM ready for FPFV”, “Timely Clean Database Declaration”)
• Significant experience in using data management methodologies and technologies.
• Proven experience in data management processes from study start to clean database declaration, incl. experience in collaboration with other functions involved in study processes (e.g., StM, Medical, EDC development, Statistics, Medical Writing).
• Proven ability to read and understand Clinical Study Protocols, Statistical Analysis Plans and Medical Review Plans, and to create data management specifications (e.g., CRF, Meta Data, Protocol Deviation Documents, Edit Check Specifications) based on these documents.
• Good understanding of regulations and guidelines (e.g. ICH, GCP).
• Fluent in oral and written English.

What ICON can offer you: Our success depends on the quality of our people. Thats why weve 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 familys 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 familys 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, inclusion & belonging are fundamental to our culture and values. Were 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, 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 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 - theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles. #LI-JC3 #LI-Remote

Information :

• Company : ICON
• Position : Principal Clinical Data Science Lead (Sponsor Dedicated)
• Location : Remote
• Country : ZA