Senior Clinical Data Manager

🕒 April 3

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

📊 Data Scientist

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Oversee, lead, manage, and provide technical expertise within the assigned projects to ensure that they are executed in an efficient, accurate, and timely manner to the Sponsor’s satisfaction. • Provide fully independent and autonomous leadership of data management services (start up, conduct, and close out) across multiple complex global projects/programs. • Ensure appropriate resources are allocated to complete all DM activities on time and within budget. • Prepare DM trial documentation (DMP, DB Specifications, Edit check specifications, CCGs, DTAs). • Ensure effective UAT is performed. • Write external vendor reconciliation specifications for programming reconciliation outputs (e.g., Serious Adverse Events, IRT, Central Laboratory). • Oversee data cleaning activities. • Produce metrics to monitor the progress of trial activities. • Ensure all database lock activities are completed on time. • Represent WorldWide DM at both internal and external study meeting calls, including providing input. • Monitor project scope, budgets, and risks and alert DM Management of any concerns. • Liaise with DM Management at regular intervals to discuss progress and any issues outstanding (e.g., during Project Review Meetings). • Collaborate with internal Worldwide departments working on the same project. • Provide feedback on process improvements to DM Management and/or SMEs. • Participate in and lead process reviews. • Provide training, support, and mentorship to other members of the DM department. • Participate as necessary in sponsor audits, regulatory authority inspections, and other third-party meetings.

🎯 Requirements

• Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or related discipline — or equivalent relevant experience. • Min of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries. • Strong knowledge of data management best practices & technologies as applied to clinical trials. • Excellent communication and interpersonal skills to collaborate with cross-functional internal and external teams. • Strong understanding of clinical trial process and protocols documents (protocols, statistical analysis plans, CRFs, study reports) and processes. • Strong analytical and problem-solving skills. • Independent and autonomous project oversight skills.

🏖️ Benefits

• Diverse and inclusive environment • Professional development opportunities