Director, eClinical Technology at CSL Limited in Holly Springs, NC
Technical Innovation & Strategy Partnering with IT and Clinical Development Business Process Owners, deliver the Clinical Development IT Systems Roadmap Provide strategic leadership to, and management of clinical and operations data within or across a designated Therapeutic Area (TA) or is a member of a function that supports the delivery of the portfolio. You will be fully accountable for all deliverables to support the TA Functions; this activity includes Data Management, eClinical Operations, R&D Business Support, Clinical Programming, Performance Management as well as Central Monitoring (Risk Based Monitoring) The AD eClinical Technology is expected to influence both the business and the IT interface for all systems that are used in Clinical Development The AD eClinical Technology must stay current with Vendor Product Offerings and Enabling Technologies, proposing applicability of new or changing systems, and leading the implementation of large, complex projects to deliver the applicable systems to Seqirus Clinical Development The AD eClinical Technology will represent Clinical Development in workshops and other activities intended to enhance operational efficiencies Manage a system within the overall eClinical Technology suite of systems for the Therapeutic areas. For the system, translates business needs into the eClinical Roadmap. Implements, maintains and supports eClinical solutions. Change Management Lead Clinical Development Change Management Initiatives necessitated by new and changing technology, including assessing impact and developing appropriate communications to ensure smooth transitions, accounting for all geographies and constraints. Provide Targeted Communications to the broader R&D organization as needed to ensure alignment with Clinical Development technologies in use Vendor Management Manage complex interactions with vendors, including on-boarding of vendor resources, oversight of vendor deliverable quality and timeliness Enforce vendor adherence to Seqirus SOPs and related policies (i.e. ITQMS) Monitor and ensure delivery against statements of work and other contractual vendor agreements Project Delivery Following ITQMS and IT Processes, serve as strategic leader for Clinical Development for new systems and upgrades for clinical systems Maintain and manage project risks, issues, and mitigations Develop annual IT budget for Clinical Development and track and report project spending against budget Qualifications, Skills & Experience To succeed in this role, the jobholder will have University/College degree (BSc, MSc, Diploma) in an IT, technical or life science discipline or similar education. A Master's degree is highly desirable 10
years' experience working in clinical data management, statistical programming or clinical systems within the CRO/pharmaceutical environment. Proven leadership and global Clinical Operations experience is essential. Strong analytical skills with a focus on process mapping Comprehensive understanding of clinical trial processes, including knowledge of ICH-GCP regulations and the conduct of clinical studies Familiar with international IT guidelines for the conduct of clinical trials In-Depth Knowledge of Computer Systems Validation and other international guidance on the Qualification and Use of Computer Systems, specifically GAMP, 21 CFR Part 11, HIPAA, and GDPR
Salary Range:
$200K -- $250K
Minimum Qualification
Data Science & Machine Learning, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
years' experience working in clinical data management, statistical programming or clinical systems within the CRO/pharmaceutical environment. Proven leadership and global Clinical Operations experience is essential. Strong analytical skills with a focus on process mapping Comprehensive understanding of clinical trial processes, including knowledge of ICH-GCP regulations and the conduct of clinical studies Familiar with international IT guidelines for the conduct of clinical trials In-Depth Knowledge of Computer Systems Validation and other international guidance on the Qualification and Use of Computer Systems, specifically GAMP, 21 CFR Part 11, HIPAA, and GDPR
Salary Range:
$200K -- $250K
Minimum Qualification
Data Science & Machine Learning, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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