Senior Clinical Data Manager

🔥 1 minute ago

🌐 Mexico, Brazil, +1 more countries – Remote

🇲🇽 Mexico – Remote 🇧🇷 Brazil – Remote 🇨🇴 Colombia – 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 for assigned clinical projects/programs, ensuring continuity, responsiveness, backup coverage, and timely task completion • Oversee project data entry processes, including data entry guidelines, training, quality, and resourcing • Provide input on and manage timelines, deadlines, and resource needs • Develop CRF specifications from clinical study protocols and coordinate stakeholder review • Assist with clinical database builds and conduct database build user acceptance testing • Maintain quality-controlled database build documentation and oversee clinical database quality • Specify and oversee edit-check and manual data-review requirements • 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-related items • Review and query clinical trial data according to the Data Management Plan • Perform line-listing data review and patient- and study-level status and metric reporting • Perform medical coding and coordinate SAE/AE reconciliation • Liaise with external data and EDC vendors regarding timelines and data-related 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, SAPs, and CSRs when required • Participate in development and maintenance of SOPs and process documentation • Support strategy meetings, bid defenses, capability presentations, client engagement meetings, RFP reviews, proposals, and project estimates as needed • Provide leadership for cross-functional and organization-wide initiatives • Communicate with sponsors, vendors, and project teams regarding data, database, and 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 for a Senior Clinical Data Manager; 10+ years for a Principal Clinical Data Manager • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook • Ability to handle a variety of clinical research tasks • Excellent organizational and communication skills • 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 skills and 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 • Preferred: experience in a clinical, scientific or healthcare discipline • Preferred: dictionary medical coding (MedDRA and WHODrug) • Preferred: understanding of CDISC standards (CDASH, SDTM, ADaM, etc.) • Preferred: oncology and/or orphan drug therapeutic experience

🏖️ Benefits

• May require some travel • Equal Opportunity Employer • Reasonable accommodation available for the application process • AI-generated insights may be used during the application journey, with an opt-out option