Clinical Data Manager II

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $100.7k - $166.1k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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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 under some supervision • Serve as primary Data Management contact and/or contributor for assigned clinical projects/programs • Perform data entry for paper-CRF studies and quality control of data entry as needed • Provide input into timelines and ensure clinical data management deadlines are met with quality • Assess resource needs for assigned projects as needed • Develop CRF specifications from clinical study protocols and coordinate stakeholder review and feedback • Assist in building clinical databases • Conduct database build UAT and maintain quality-controlled database build documentation • Oversee overall clinical database quality • Specify requirements for electronic, manual data review, and other edit checks • 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 study-specific CRFs, EDC, and related items • Review and query clinical trial data according to the Data Management Plan • Perform line-listing data review • Run patient- and study-level status and metric reporting • Perform medical coding of medical terms • Coordinate SAE/AE reconciliation • Liaise with third-party data and EDC vendors in a project manager capacity • Assist with SAS programming and quality control of SAS programs • Identify and troubleshoot operational problems using metrics data, audit reports, and stakeholder input • Review and provide feedback on protocols, SAPs, and CSRs as required • Participate in developing and maintaining SOPs and process documentation • Attend strategy meetings, bid-defense preparation, capability presentations, and client engagement meetings as needed • Review RFPs, proposals, and provide project estimates • 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 • 5+ years’ Clinical Data Management experience or demonstrated aptitude in the key skills for the role • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook • Able to handle a variety of clinical research tasks • Excellent organizational and communication skills • Must be able to read, write, speak fluently and comprehend the English language to enable communication across Precision for Medicine and with clients • Experience in utilizing a clinical database management system • Broad knowledge of drug, device and/or biologic development and effective data management practices • Ability to undertake occasional travel • Candidates must be legally authorized to work in the country of employment without employer sponsorship. • Preferred: Understanding of dictionary medical coding (MedDRA and WHODrug) • Preferred: Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) • Preferred: Oncology 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 employment • Reasonable accommodation during the application process

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