Principal Duties and Responsibilities:
Collaborate closely with clients on study design, eCRF design, data review, and data cleaning activities. Plan, implement, and perform data management tasks and operational aspects of individual projects. Ensure the quality of data submitted from study sites and assure timely entry into the database. Maintain study compliance with the protocol, GCP guidelines, and applicable regulatory requirements. Track and manage study timelines, project milestones, and potential risks. Provide support and training to designated staff, and contribute to cross-functional tasks and processes. Foster positive relationships with external vendors, and support new system development initiatives.
Communicate with the business development team to manage relationships with external vendors. Work collaboratively with vendors to develop and implement technical tools supporting business needs. Support cost proposals, client presentations, and data management at bid defenses.
Proactively identify challenges and recommend solutions, and support vendor and customer audits as assigned.
A Bachelor's Degree is required. Extensive knowledge of GCP and ICH guidelines is essential. Strong experience in data review and cleaning is highly desirable. Proficiency in Microsoft Office and experience with data capture systems are necessary. Clinical research experience, ideally within a pharmaceutical or medical device company, hospital, or CRO, is preferred.
Experience with statistics, programming, and field monitoring will be considered a plus. Leadership skills and a positive personality are required. Effective verbal and written communication skills are a must.
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Company Name: Lifelancer
Job Title: Clinical Data Management Specialist