Senior Clinical Data Manager II

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

Biotechnology • Healthcare Insurance • Pharmaceuticals

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.

📋 Description

• 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), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing. • May perform quality control of data entry. • Provide input, assess and manage timelines. Ensure clinical data management deadlines are met with quality. • Conduct database build UAT and maintain quality controlled database build documentation. • Responsible for creating, revising, versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. • Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. • Review and query clinical trial data according to the Data Management Plan. • Coordinate SAE/AE reconciliation. • Liaise with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables. • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members.

🎯 Requirements

• Bachelors and/or a combination of related experience • 8+ years’ experience as a Sr. Clinical Data Manager or 5+ Years as a Clinical Data Manager II working for a Clinical Research Organisation, Pharmaceutical or Biotech company • Set up and Database migrations experience • Oncology experience preferred • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook • 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.

🏖️ Benefits

• We can consider candidates based in the UK, Poland, Hungary, Romania, Serbia or Slovakia. • Competitive salary