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    Clinical Data Manager

    Digital Prospectors
    5+ years
    Not Disclosed
    Remote, USA
    10 Oct. 29, 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, CPC Certified, 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 Manager

    Position: Clinical Data Manager
    Location: Bedford, MA (Remote)
    Length: 12 months

    About the Job

    Our client is seeking a skilled and detail-oriented Clinical Data Manager to join their dynamic team. This role is crucial in ensuring the integrity and compliance of clinical data management processes in alignment with regulatory standards. As a key member of the Data Management team, you will support clinical trial activities, prepare data for regulatory submissions, and collaborate with various stakeholders to ensure high-quality outcomes. If you are passionate about clinical data management and have a proven track record in the field, we encourage you to apply today!

    Essential Duties and Responsibilities

    • Ensure compliance with regulatory standards (i.e., FDA, ICH GCP) and company SOPs throughout data management activities.
    • Assist in the preparation of clinical data for regulatory submissions and audits.
    • Provide data-related support during clinical trial activities and in interactions with regulatory agencies.
    • Maintain detailed documentation of data management activities, including quality control measures and processes.
    • Collaborate closely with clinical research teams, biostatisticians, and other stakeholders to support submission preparations and project goals.

    Qualifications

    • Bachelor’s degree in Life Sciences, Data Management, Biostatistics, or a relevant field.
    • At least 7 years of experience in Data Management, with a focus on submission preparation.
    • Proven experience in clinical data management, preferably within a pharmaceutical, biotechnology, or clinical research environment.
    • Audit preparation experience and legacy studies experience are required.
    • Strong knowledge of regulatory requirements and industry standards for clinical data management.
    • A strong analytical and data-driven mindset.
    • Excellent attention to detail and organizational skills.
    • Strong communication and interpersonal skills, with the ability to work effectively in a team-oriented environment.

    Additional Information

    • POST-OFFER BACKGROUND CHECK IS REQUIRED.
    • Digital Prospectors is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.

    Make this your next career move as one of our many long-term contractors or employees! Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.

    Why Work with Us?

    • 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
    • Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts and recognized as a ‘Best Company to Work For’ by Forbes, Fortune, and Inc. magazine.

    As you apply, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today!

    Website: www.LoveYourJob.com

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