Job Description

OverviewAs a Senior Clinical Data Science Lead you will be joining the worldxe2x80x99s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Immediate Joiner RequiredOfficebased - Bangalore/Chennai/TrivandrumResponsibilities

• Works collaboratively with CROs and third-party vendors to design database, define quality specs, and resolve data management-related issues.
• Assists in developing and maintaining DM standards and processes for both in-house and CRO studies in accordance with applicable SOPs and good clinical practices (GCP).
• Provides consultation, leadership, and expertise to CRO DM and project teams on data management functions.
• Acts as the data management lead for all assigned protocols, including contributing to the development and implementation of project plan.
• Ensure standard processes are followed by all CROs for data management activities. Train CRO personnel on current processes.
• Uses software applications to monitor and evaluate CRO performance (eg query status, data trends, detecting outliers and study progress).
• Acts as a resource to the contract staff to identify problems and propose solutions to maintain projects within designated timelines.
• Proactively identifies and implements opportunities for process improvements.
• Provides expert review and help in the development of CRF/eCRF/eSource design specifications, validation specifications and report design, etc. Works with external service providers to help troubleshoot and resolve problems.
• Ensures the consistency of CRF design and coding across studies and programs.
• Contributes to protocols, clinical study reports, Investigator Brochures, Statistical Analysis Plans, INDs and other regulatory documents.
• Prepares submission ready Electronic Case Report Forms (eCRFs) to support electronic submissions.

Reviews SOW, provides input and ensures consistency across programs for data management activities to be outsourced to CROs.

• Manages third-party vendorsxe2x80x99 (eg, CROs, EDC/eSource, and ancillary) processes, and local/central laboratories on defined data standards, content specifications, and timelines for deliverables.
• Communicates and interacts with CRO vendors to ensure that project timelines are met with quality.
• Provides status reports on the progress of projects/programs to internal team.
• Ensures data management-related presentations for Investigatorxe2x80x99s meetings adhere to clientxe2x80x99s requirements.
• Provides input in the development of departmental and global SOPs.
• Serves as project team member and works closely with biostatistician and programmer to provide quality deliverables.
• Other tasks assigned by Associate Director, Director or Sr. Director of Data Management

Qualifications

• Bachelorxe2x80x99s degree with a minimum of 8 years of experience in data management, as well as pharmaceutical industry experience.

• Strong understanding of medical concepts and terminology.
• Knowledge of CDISC and industry standards
• Strong working knowledge of data management practices and applicable global regulatory requirements
• Strong working knowledge of electronic data capture systems, eSource and familiarity with regulatory guidelines on use of electronic systems.
• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs.
• Know how/when to apply organizational policy or procedures to a variety of situations. Strong oral and written communication/presentation skills.

What ICON can offer you:Our success depends on the quality of our people. Thatxe2x80x99s why wexe2x80x99ve 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 familyxe2x80x99s 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 familyxe2x80x99s 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/benefitsAt 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 wexe2x80x99ve done to become a more inclusive organisation. Wexe2x80x99re 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-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless xe2x80x93 therexe2x80x99s every chance youxe2x80x99re exactly what wexe2x80x99re looking for here at ICON whether it is for this or other roles.

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