Senior Clinical Data Manager

🔥 14 hours ago

🌐 United Kingdom, Poland, +4 more countries – Remote

🇬🇧 United Kingdom – Remote 🇵🇱 Poland – Remote 🇭🇺 Hungary – Remote 🇷🇴 Romania – Remote 🇷🇸 Serbia – Remote 🇸🇰 Slovakia – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 21%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

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

• Manage all aspects of the clinical trial data management process from study start-up through post-database lock for assigned projects • Serve as primary Data Management contact and Lead Data Manager for assigned clinical projects/programs • Oversee project data entry, including guidelines, training, quality, and resourcing • Assess and manage timelines, deadlines, and resource needs • Develop CRF specifications and coordinate stakeholder review and feedback • Conduct database build UAT and maintain controlled database-build documentation • Oversee clinical database quality and edit-check specifications • Create, revise, version, and maintain data-management documentation and Trial Master File completeness • Train clinical research personnel and data-management project team members • Review and query clinical trial data according to the Data Management Plan • Perform line-listing data review and patient/study-level status and metric reporting • Perform medical coding and coordinate SAE/AE reconciliation • Liaise with third-party data and EDC vendors regarding timelines and data deliverables • Assist with SAS programming and quality control of SAS programs • Identify and troubleshoot operational problems using metrics, audit reports, and stakeholder input • Review and provide feedback on protocols, Statistical Analysis Plans, and Clinical Study Reports as required • Participate in developing and maintaining SOPs and process documentation • Participate in strategy meetings, bid-defense preparation, capability presentations, and client-engagement meetings • Review RFPs, proposals, and project estimates • Provide leadership for cross-functional and organization-wide initiatives • Communicate with sponsors, vendors, and project teams regarding data and database issues • Present software demonstrations, trainings, and project meetings • Perform other duties as assigned; occasional travel may be required

🎯 Requirements

• Bachelor’s degree and/or a combination of related experience • 8+ years’ experience as a Senior 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 • Professional use of the English language, written and oral • Experience utilizing various clinical database management systems • Broad knowledge of drug, device and/or biologic development and effective data management practices • Strong representational, organizational, communication, leadership, and interpersonal skills • Ability to undertake occasional travel • Must be legally authorized to work in the country of employment without employer sponsorship

🏖️ Benefits

• Regular full-time employment • Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities • No employer sponsorship required; candidates must be legally authorized to work in the country of employment