We are a leading provider of pharmaceutical support services, partnering with life science companies to demonstrate value, ensure safe use and accelerate patient access to innovative medical products. Our services range from supporting the largest brands in the industry, to providing fully outsourced functional services, to the most recently approved genetic therapies in orphan populations. The work we do positively impacts patients’ lives all over the world.
We are currently looking for a Clinical Data Manager - 12 month FTC.
Brief Description:
Manage, oversee and prioritize tasks related to data management to meet company objectives, departmental and project needs. Responsible for the data management team to provide quality data to the sponsors.
Specific job duties:
Contribute to the leadership and oversight of Data Management (DM) operations within the Evidence Development Operations department. Serve as UBC DM oversight contact for data related activities on multiple projects from start-up through database lock. Serve as the UBC data management oversight contact for select projects and governance meetings. Contribute to the development and review of Data Management SOPs, Work Instructions and templates/standards incorporating the industry's best practices and any applicable regulatory requirements and ICH guidelines. Lead to interdepartmental initiatives, SOP review, EDC Designs, protocol design, and overall data management operations. Provide support and oversight on: All DM documentation (e.g., data review plans, data transfer plans, coding guidelines, CRF completion guidelines, database finalization and freeze/lock, etc.).Design/develop database build specifications (i.e., CRFs/ePROs, Visit/form configuration specifications, edit check specifications) to meet study data requirements per acceptance testing (UAT) activities of study databases and external vendor systems. Provide guidance on project-specific EDC/database designs to ensure they adhere to regulatory standards, follow best practices, provide efficiencies, and produce quality final data. Provide DM oversight for the review of revenue recognition workbooks with the Project Manager(s) when DM tasks are completed for each month/phase of the project to ensure client payments. Lead business development activities for data management including development of scope and costs, author proposals and requests for information documents; participate in bid defences and capabilities presentations. Responsible for the review of the study statement of work, RFPs, budgets, and Change Orders Serve as departmental representative on internal/sponsor data management audits. Manage data management resources across the organization to ensure staff assignments are appropriate to meet departmental utilization targets. Ensures allocated resources are aligned with current and forecasted work in terms of capability, quantity, timing, and efficiency. Provide objective performance reviews, deliver feedback, and make recommendations for promotion. Provide on-going coaching to each team member concerning quality, reliability, accountability, and productivity. Serve as Lead Data Manager on projects as necessary. Assures project activities are performed within the scope of the project and according to the timelines. Other duties as assigned by management.
Desired Skills and Qualifications:
College graduate in a science or equivalency in clinical data experience Solid understanding of Good Clinical Practices, Clinical research, Clinical Trial process and related regulatory requirements and terminology Solid understanding of CDASH/CDISC Minimum 12 years clinical data management experience Experience in all stages of clinical trials, observational studies, and RWE. Excellent interpersonal skills with strong communication and organizational skills. Willingness to travel up to 25%
