Senior Clinical Data Manager

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 Description

• Lead or support data management study activities, CRO oversight, and driving deliverable timelines. • Strong knowledge of EDC builds. • Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and client for all data related deliverables, especially in support of key decision points and regulatory submissions. • Contributes influential leadership in collaboration with other client Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality. • Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks. • Provides input to functional governance with client strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams. • Participates in preparing function for submission readiness and may represent function in a formal inspection or audit. • Participates and represents function in formal inspections and audits as requested. • Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents. • Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics. • Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting. • Acts as a process expert for operational and oversight models. • Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models. • May prepare metrics to support the function’s KPIs. • Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of client. • Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements. • Ensure compliance with own Learning Curricula, corporate and/or GXP requirements. • Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.

🎯 Requirements

• Bachelor's Degree in a science, health related, or information technology field required. • Minimum 5 years experience in Clinical Data Management. • Experience with all phases of development in one or more therapeutic areas preferred. • Strong knowledge of data management best practices & technologies as applied to clinical trials. • Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes. • Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process. • Strong knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.

🏖️ Benefits

• Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. • We work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. • Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.