Clinical Data Manager, Project Data Manager

🔥 0 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Perform activities related to Phase I–III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and relevant procedures and guidelines • Ensure assigned trials are delivered on time, within budget, and with the highest achievable quality from a data management perspective • Serve as the primary data management representative on Incyte multidisciplinary project teams • Maintain effective communication with project teams • Communicate clinical data management metrics, including data entry status and query resolution and aging • Determine appropriate actions with the study team • Review, develop, and write clinical trial documents and manuals, including Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans, and eCRF Completion Guidelines • Participate in User Acceptance Testing and Quality Control as needed • Work with Clinical Database Programmers on Data Flow Charts, Data Transfer Specifications, and Import Guidelines • Assist with site and third-party vendor training on CDM-related topics • Provide data review training and guidance to Senior Clinical Data Coordinators • Perform data review and discrepancy resolution as needed • Archive trials and associated documentation upon completion • Ensure adherence to Good Clinical Practice and applicable local and international regulations

🎯 Requirements

• Minimum of 5 years of data management experience • Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT) is preferred, but individuals with commensurate experience will be considered • Experience with Electronic Data Capture (EDC) system(s) is required • Experience with Oracle Inc.'s Inform™ EDC system is preferred • Oncology and/or inflammatory therapeutic area experience is preferred • Project management experience within Data Management is preferred • Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is preferred • Adherence to ICH/Good Clinical Practices (GCP) and applicable local and international regulations

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate