Senior Clinical Data Manager

🔥 1 minute ago

🌐 Brazil, Colombia, +1 more countries – Remote

🇧🇷 Brazil – Remote 🇨🇴 Colombia – Remote 🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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 • Follow SOPs/WIs, regulatory directives, study-specific plans and guidelines • Serve as primary Data Management contact and Lead DM for assigned clinical projects/programs • Provide backup support and/or team-member support to other Lead Data Managers; may oversee sponsor programs • Oversee data entry processes, including data entry guidelines, training, quality and resourcing • Perform quality control of data entry when required • Assess and manage project timelines, deadlines and resource needs • Develop CRF specifications from clinical study protocols and coordinate stakeholder review • Assist with clinical database building • Conduct database build UAT and maintain controlled database build documentation • Oversee clinical database quality • Specify and oversee electronic/manual edit checks and manual data review specifications • Create, revise, version and maintain data management documentation and oversee 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/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 when required • 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 SOP and process-documentation development and maintenance • Support strategy meetings, bid defenses, capability presentations and potential client engagement meetings • Review RFPs, proposals and provide project estimates when required • Provide leadership for cross-functional and organization-wide initiatives • Communicate with study sponsors, vendors and project teams regarding data, database and project issues • Present software demonstrations, trainings and project meetings • Perform other assigned duties

🎯 Requirements

• Bachelor's degree and/or a combination of related experience • 8+ years’ experience for a Senior 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 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 • 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 • Candidates must be legally authorized to work in the country of employment without employer sponsorship

🏖️ Benefits

• May require some travel • 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