Job summary
Job post source
This job is directly from cGxPServe
Job overview
The Lead Clinical Data Manager at cGxPServe oversees data management activities for clinical programs, ensuring data quality and compliance from database start-up to lock, impacting clinical trial success.
Responsibilities and impact
The role involves managing CRO data management activities, coordinating with internal teams and vendors, overseeing database development and data cleaning, reviewing study documents, tracking metrics, troubleshooting data issues, and supporting audits and SOP development.
Experience and skills
Requires a bachelor's degree in science or IT, 8+ years in data management within pharma/biotech or CRO, familiarity with CDISC/CDASH, coding dictionaries, Pinnacle 21, EDC software, strong organizational and project management skills, and knowledge of clinical research and regulatory requirements.
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 extensive data management experience overseeing CRO activities from database start-up through database lock, emphasizing your leadership in clinical data processes.
Stress your familiarity with CDISC/CDASH standards, Pinnacle 21, and various EDC systems like Medidata RAVE and Veeva CTMS, as well as your ability to manage vendor oversight and cross-functional collaboration.
Apply through multiple channels including cGxPServe's corporate website, LinkedIn, and relevant clinical research job boards to maximize your application reach.
Connect on LinkedIn with professionals in cGxPServe’s clinical data management or clinical operations teams; open conversations by referencing recent company projects, asking about team culture, or inquiring about challenges faced in managing clinical data.
Optimize your resume for ATS by incorporating keywords such as 'clinical data management,' 'CRO oversight,' 'CDISC,' 'EDC,' 'data validation,' and 'clinical trial phases I-IV' to ensure your resume passes automated screenings.
Leverage Jennie Johnson's Power Apply feature to automate tailored applications, identify multiple application sites, and discover LinkedIn contacts, freeing you to focus on strategic networking and interview preparation.
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