Senior Clinical Data Manager

🔥 1 hour ago

🌐 Poland, Hungary, +3 more countries – Remote

🇵🇱 Poland – Remote 🇭🇺 Hungary – Remote 🇷🇴 Romania – Remote 🇷🇸 Serbia – Remote 🇸🇰 Slovakia – Remote

💵 zł190.2k - zł285.4k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Manage all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects • Serve as primary Data Management contact and Lead DM for assigned clinical projects/programs • Oversee project data entry, guidelines, training, quality, and resourcing • Provide input on and manage timelines, deadlines, and resource needs • Develop CRF specifications and coordinate stakeholder review and feedback • Conduct database build UAT and maintain quality-controlled database build documentation • Oversee clinical database quality and edit-check specifications • Create, revise, version, and maintain data management documentation and Trial Master File documentation • 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 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 • Troubleshoot operational problems using metrics, audit reports, and stakeholder input • Review and provide feedback on protocols, SAPs, and CSRs when required • Participate in SOP and process documentation development • Support strategy meetings, bid defenses, capability presentations, client engagements, RFP reviews, and project estimates • Lead cross-functional and organization-wide initiatives where applicable • Communicate with sponsors, vendors, and project teams regarding project issues • Present software demonstrations, trainings, and project meetings • Perform other duties as assigned

🎯 Requirements

• Bachelor's degree 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 • 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

• Discretionary annual bonus • Private medical insurance • MultiSport Card • Life insurance • Pension • Home working allowance • Vacation • Some travel opportunities