Senior Clinical Data Manager - Principal Clinical Data Manager

February 8

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Precision Medicine Group

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Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

📋 Description

• The Senior Clinical Data Manager/Principal Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. • Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s). • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing. • Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders. • Conduct database build UAT and maintain quality controlled database build documentation. • Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. • Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM. • Provide leadership for cross-functional and organization-wide initiatives.

🎯 Requirements

• 8+ years’ experience for a Sr. Clinical Data Manager and 10+ years for a Principal Clinical Data Manager • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook • Able to handle a variety of clinical research tasks • Excellent organizational and communication skills • Professional use of the English language; both written and oral • Experience in utilizing various clinical database management systems • Broad knowledge of drug, device and/or biologic development and effective data management practices • Strong representational skills, ability to communicate effectively orally and in writing • Strong leadership and interpersonal skills • Ability to undertake occasional travel • Experience in a clinical, scientific or healthcare discipline • Dictionary medical coding (MedDRA and WHODrug) • Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) • Oncology and/or Orphan Drug therapeutic experience