Principal Clinical Data Manager

🔥 12 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $114k - $150k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

🦅 H1B Visa Sponsor

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Veristat

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💼 Consulting

🏥 Healthcare

💊 Pharmaceuticals

💰 Private equity on 2021-05

Consulting • Healthcare • Pharmaceuticals

Veristat is a clinical development services company that provides end-to-end, regulatory-focused support for biopharmaceutical and medical device sponsors. The firm offers full-service clinical trial planning and conduct, regulatory affairs and submission support (including NDA/MAA and interactions with agencies like PMDA), statistical and biometrics services, medical writing, pharmacovigilance, and project management for complex therapeutic areas such as oncology, rare diseases, neurology, biologics, and cell & gene therapies. Veristat operates as a B2B partner to biotech and pharmaceutical organizations to reduce development risk and accelerate regulatory approval.

📋 Description

• Perform data management tasks from study start-up through database lock for assigned clinical research projects • Manage paper-based and electronic data capture (EDC) studies • Ensure overall data quality and documentation on clinical research projects • Work on mid-to-large complex projects across various indications • Serve at times as program manager overseeing multiple studies for the same client • Lead a team of clinical data managers to ensure contracted activities follow Veristat Standard Operating Procedures and/or sponsor-specific requirements • Promote consistent operations, efficient resource use, knowledge sharing, and best practices with Data Management leadership • Assist with training data managers on project-specific and general data management processes, procedures, and systems • Provide training to other company functions as needed

🎯 Requirements

• Bachelor’s degree in a related field & 7+ years of relevant experience • At least 5 years’ experience in clinical data management in a clinical research setting • 4 years of experience in leading project teams • Thorough knowledge of ICH Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines • Knowledge of medical terminology, clinical trials, and clinical research • Working knowledge of CRO industry relationships and regulatory obligations with pharmaceutical/biotech companies • Demonstrated technical leadership and ability to lead by example • Ability to serve as an internal and external consultant and influence without authority • Ability to operate with the “big picture” in mind and advise management • Expert-level computer skills, including clinical trial databases and applications such as IBM Clinical Development and Medidata RaveX • Strong desire and ability to learn new applications • Detailed understanding of project planning and management methods • Excellent interpersonal, communication, and organizational skills • Ability to work independently and in a team environment • Ability to work across projects with differing priorities, mentor teams, and provide data management expertise

🏖️ Benefits

• Remote working • Flexible time off • Paid holidays • Medical insurance • Tuition reimbursement • Retirement plans • Applicable bonus