Senior Clinical Data Manager

🔥 2 minutes ago

🌐 Mexico, Brazil, +4 more countries – Remote

🇲🇽 Mexico – Remote 🇧🇷 Brazil – Remote 🇦🇷 Argentina – Remote 🇨🇴 Colombia – Remote 🇨🇱 Chile – Remote 🇵🇪 Peru – 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

• Serve as the primary Data Management contact and Lead DM for assigned clinical projects/programs • Oversee data entry processes, guidelines, training, quality, and resourcing • Manage timelines, resource needs, and clinical data management deadlines • Develop CRF specifications from clinical study protocols and coordinate stakeholder review • Assist with clinical database builds and conduct database build UAT • Oversee database quality, edit check specifications, manual data review specifications, and build documentation • Create, revise, version, and maintain data management documentation and Trial Master File completeness • Train clinical research personnel and data management project team members on CRFs, EDC, and project requirements • Review and query clinical trial data according to the Data Management Plan • Perform line-listing data reviews 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 • Troubleshoot operational problems using metrics, audit reports, and stakeholder input • Participate in SOP development, protocol/SAP/CSR review, strategy meetings, proposals, and client engagements as needed • Provide leadership for cross-functional and organization-wide initiatives • Communicate with sponsors, vendors, and project teams regarding data and database issues • May require occasional travel and other assigned duties

🎯 Requirements

• Bachelor's degree and/or a combination of related experience • 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 • Candidates must be legally authorized to work in the country of employment without employer sponsorship.