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    Clinical Data Associate/Senior Clinical Data Associate

    Precision For Medicine
    4+ years
    Not Disclosed
    Remote, USA
    10 Aug. 2, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Opportunity: Clinical Data Associate/Senior Clinical Data Associate

    Company: Precision for Medicine

    Location: [Specify Location]

    About Us: Precision for Medicine is a precision medicine CRO. Our uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and a passion for rare diseases and oncology. We also work across other therapeutic areas.

    Position Overview: Precision for Medicine is seeking an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. Under direct supervision, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans. This role encompasses a range of responsibilities, including data cleaning and reconciliations, database testing, quality control, and collaboration within a dynamic team environment.

    Key Responsibilities:

    • Support the Lead Data Manager as a backup and team member, ensuring continuity and timely task performance.
    • Perform data entry for paper-CRF studies as needed.
    • Conduct quality control of data entry.
    • Provide input into timelines to ensure clinical data management deadlines are met with quality.
    • Develop CRF specifications from the clinical study protocol and coordinate review/feedback from stakeholders.
    • Assist in building and testing clinical databases, maintaining quality-controlled documentation.
    • Specify requirements for all edit check types (electronic, manual data review, etc.).
    • Create, revise, appropriately version, and maintain data management documentation.
    • Train clinical research personnel on study-specific CRF, EDC, and other project-related items.
    • Review and query clinical trial data according to the Data Management Plan.
    • Perform line listing data review based on guidance from the sponsor and/or Lead Data Manager.
    • Run patient and study-level status and metric reporting.
    • Perform medical coding of medical terms to ensure medical logic and consistency.
    • Assist with coordinating SAE/AE reconciliation.
    • Liaise with third-party vendors such as external data and EDC vendors to support timelines and data-related deliverables.
    • Assist with SAS programming and quality control of SAS programs used in the Data Management department.
    • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and stakeholders.
    • Provide feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs) if required by the project.
    • Participate in the development and maintenance of SOPs and process documentation related to data management and database management activities.
    • Ensure all data management project team members have been sufficiently trained.
    • Communicate with study sponsors, vendors, and project teams regarding data, database, or other relevant project issues.
    • Present software demonstrations/trainings, department/company training sessions, and project meetings.
    • Perform other duties as assigned.

    Qualifications:

    Minimum Required:

    • 4+ years of experience in Data Management.
    • Bachelor's degree in a scientific or science-related field or a combination of related experience.
    • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
    • Ability to handle various data management tasks and oversight.
    • Excellent organizational and communication skills.
    • Professional use of the English language, both written and oral.
    • Basic knowledge of drug, device, and/or biologic development and effective data management practices.

    Preferred:

    • Experience in a clinical, scientific, or healthcare discipline.
    • Proficiency in medical coding dictionaries (MedDRA and WHODrug).
    • Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.).
    • Experience in oncology and/or orphan drug therapeutic areas.

    Skills and Competencies:

    • Strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance with the ability to implement and drive outcomes.
    • Ability to motivate project team members to meet timelines and project goals.
    • Focus on continuous improvement, proactively assessing how to enhance process efficiency and effectiveness.
    • Ability to resolve project-related problems and prioritize workload to meet deadlines with minimal support.
    • High degree of self-motivation, working independently and in a team environment.
    • Professionalism evidenced by punctuality, commitment, service culture, and positive interactions with customers and teammates.

    Equal Opportunity Employer: Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law.

    Application Process: Any data provided as part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please refer to our CA Privacy Notice.

    If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in your ability to access or use this online application process, please contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

    Fraud Alert: It has come to our attention that some individuals or organizations are posing as potential employers, presenting fraudulent job offers. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers, and a formal interview process.

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