Senior Clinical Data Manager

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $133.9k - $200.9k / 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, including guidelines, training, quality, and resourcing • Provide input on and manage timelines, deadlines, quality, and resource needs • Develop CRF specifications from clinical study protocols and coordinate stakeholder review • Assist with building clinical databases • Conduct database build UAT and maintain quality-controlled database build documentation • Oversee clinical database quality and edit-check/manual data-review 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 metric reporting • Perform medical coding and coordinate SAE/AE reconciliation • Liaise with third-party data and EDC vendors to support timelines and 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 SOP and process documentation development and maintenance • Participate in strategy meetings, bid defenses, capability presentations, and client engagement meetings • Review RFPs, proposals, and provide project estimates • Provide leadership for cross-functional and organization-wide initiatives • Communicate with study sponsors, vendors, and project teams • Present software demonstrations, trainings, and project meetings • Perform other duties as assigned • May require some travel

🎯 Requirements

• Bachelors and/or a combination of related experience • 8+ years’ experience as a 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 • 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

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation • Equal Opportunity Employer

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