Senior Clinical Data Manager

🔥 0 minutes 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

👻 Ghost score 11%

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 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, including guidelines, training, quality, and resourcing • Assess and manage timelines, deadlines, and resource needs • Develop CRF specifications and coordinate stakeholder review • 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 status and metrics reporting • Perform medical coding and coordinate SAE/AE reconciliation • Liaise with third-party data and EDC vendors regarding timelines and deliverables • Troubleshoot operational problems using metrics, audit reports, and stakeholder input • Participate in SOP development and maintenance • Communicate with sponsors, vendors, and project teams regarding data and database issues • May assist with SAS programming and quality control • May review protocols, SAPs, CSRs, RFPs, proposals, and project estimates • Provide leadership for cross-functional initiatives • May attend meetings, presentations, software demonstrations, and trainings • May require some travel • 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 • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook • Excellent organizational and communication skills • Professional use of the English language, both 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 skills, with ability to communicate effectively orally and in writing • Strong leadership and interpersonal skills • Ability to undertake occasional travel • Candidates 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