Senior Data Manager

Senior Data Manager 

Contract – Remote in US – 40 Hours 

ClinChoice is a full-service global clinical CRO dedicated to offering high-quality, efficient and flexible solutions to pharmaceutical, biotechnology, medical device, and consumer products clients worldwide. With a 25-year history of success, ClinChoice continues to be The Standard of Excellence for biostatistics, clinical operations, data management, statistical programming, CDISC, regulatory affairs, medical affairs and pharmacovigilance. ClinChoice has established major delivery centers across US, China, Europe, Canada, India, Japan and the Philippines. It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America and Europe. 

The Senior Data Manager collaborates with clinical project team members and external organizations to ensure clinical trial data quality and integrity while mitigating potential risks to the studies/projects. 

Responsibilities: 

• Lead data management activities for one or more clinical studies or projects, working closely with Pharma Drug Development colleagues, Research HQ, external consultants, key opinion leaders, medical advisors, and Contract Research Organizations (CROs)/contractors. 

• Fulfill the role of Study Data Manager, leading data management activities, collaborating with clinical colleagues, and ensuring data integrity and risk reduction. 

• Select and manage appropriate Electronic Data Capture (EDC) systems, Direct Data Capture (DDC), eSource, or electronic Clinical Outcome Assessment (eCOA)/electronic Patient Reported Outcome (ePRO) software. 

• Conduct in-house review of clinical trial data, identify discrepancies, missing values, and out-of-range values, and generate queries for resolution. 

• Participate in quality control activities, including risk-based monitoring (RBM) 

• Develop and maintain study documents related to data management, such as data management plans, electronic Case Report Forms (eCRFs), data transfer specifications, edit check specifications, and Data Quality Review Plans 

• Manage and follow up on protocol deviation logs, medical coding dictionary versioning, and lab normal range versioning. 

• Review and approve CROs' study documentation for data management areas, including eCOA systems. 

• Provide input into the selection of CROs/contractors from a data management perspective. 

• Contribute to study documents, such as project plans, study protocols, statistical analysis plans, operational documents, clinical study reports, and relevant sections of study documents. 

• Review and approve SPs' study documentation for data management areas. 

• Evaluate new data collection systems for suitability and regulatory compliance. 

• Stay updated on changes in the field of Clinical Data Management and implement new ideas and processes when applicable. 

• Collaborate with internal team members globally and external CROs on database design and format characteristics. 

• Assist the global team in harmonizing standards and processes for Data Science 

Experience: 

• Minimum of 5 years as a lead data manager in a pharmaceutical company/CRO 

• Demonstrated data management experience in a CRO, pharmaceutical, or biotechnology company with experience in overseeing outsourced data management activities. 

• Proficiency in clinical development strategic planning, study design, and implementation 

• Experience in implementing new data management processes and systems 

• Successful track record of managing CROs for data management in clinical trials 

• Understanding and compliance with GCP guidelines and global regulatory requirements 

• Knowledge of FDA regulations and guidelines, including 21 CFR Part 11, and experience with clinical trial data submissions for regulatory review 

• Strong understanding of SOPs and accepted practices in clinical development 

Additional Skills: 

• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) 

• Strong analytical and problem-solving skills 

• Methodical and detailed approach to procedures and data review while maintaining a strategic perspective. 

• Excellent written and verbal communication and presentation skills 

• Effective interaction with internal team members and external parties 

• Strong organizational skills with the ability to manage time and resources for meeting deadlines. 

• Flexible and adaptable in a dynamic work environm