cGxPServe

Clinical Data Manager

BOULDER, COPosted 22 days ago

Job summary

  • Job post source

    This job is directly from cGxPServe

  • Job overview

    The Clinical Data Manager at cGxPServe supports data management and analysis for oncology early development clinical trials, ensuring data integrity and quality for first-in-human studies through clinical proof of concept.

  • Responsibilities and impact

    The role involves overseeing CRO data management operations, reviewing deliverables for compliance with data standards and protocols, managing data reconciliation and query resolution, and ensuring adherence to regulations and quality standards.

  • Experience and skills

    Requires a bachelor's degree in a relevant field and at least 4 years of experience in pharmaceutical, clinical research, or data management, with strong knowledge of clinical trial processes, GCDMP, and effective communication and problem-solving skills.

Company overview

cGxPServe operates in the engineering and information technology sectors, specializing in research services with a focus on manufacturing, process control systems, and clinical data management. The company provides expertise in areas such as supplier quality, regulatory affairs, clinical project management, and data programming, serving clients in highly regulated industries, including medical devices and pharmaceuticals, as indicated by references to ISO 13485 and 21 CFR 820 compliance. cGxPServe generates revenue through professional services and staffing solutions, supporting roles like manufacturing engineers, clinical data managers, and regulatory specialists. With locations in California and North Carolina, the company is positioned to address complex compliance and operational needs for clients. Its history and growth reflect a commitment to supporting quality and regulatory standards in life sciences and advanced manufacturing.

How to land this job

  • Position your resume to highlight your experience and knowledge in clinical data management, especially your familiarity with oncology early development and CRO oversight, as these are key elements of the role at cGxPServe.

  • Emphasize your strong understanding of clinical trial processes, GCDMP guidelines, and your ability to manage multiple priorities in a fast-paced environment, along with your communication and problem-solving skills.

  • Apply through multiple channels such as cGxPServe's corporate career site, LinkedIn, and other job boards where the position is listed to maximize your chances of being noticed.

  • Connect with current employees or hiring managers in the Data Management and Analysis team at cGxPServe on LinkedIn. Use ice breakers like commenting on recent oncology trial advancements or asking for insights on the team’s approach to CRO oversight and data integrity.

  • Optimize your resume for ATS by incorporating keywords from the job description such as 'CRO oversight,' 'clinical trial processes,' 'GCDMP,' 'oncology data management,' and 'EDC platforms' to ensure it passes automated screenings.

  • Utilize Jennie Johnson's Power Apply feature to automate tailoring your resume, identifying multiple application sources, and finding relevant LinkedIn connections so you can focus your energy on preparing for interviews and networking.

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