Technical Specialist will work with a cross functional team of Clinical, Biostatistical and Supply Chain representatives to support the design, implementation and maintenance of outsourced electronic solutions to support a clinical trial. The individual within this role will provide technical oversight to ensure that the study specific electronic solution adheres to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.
Key Responsibilities include:
• Lead study level system requirements meetings with internal and external clients
• Design and oversee the development of study specific technical documents
• Document possible risk and implement mitigation plans
• Manage project related timelines and associated activities
• Identify and track study-related technical issues to resolution
• Provide a supportive framework for continuous process and quality improvements
• Bachelor’s Degree in life science, computer science, engineering, business or related discipline
• 4 or more years of experience in clinical operations, clinical development or clinical quality assurance
• Experience implementing clinical systems, such as CTMS, EDC, IVRS, IWRS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred
• Knowledgeable in Good Clinical Practices, and FDA regulations necessary
• Candidates should demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills
• Excellent time management and organization skills required
• Must have sound problem resolution, judgment, and decision-making abilities
• Must be able to work well in a team-based environment with minimal supervision
(No third parties, please)
(No H1s, please)
(Local candidates only, please)
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SMCI is an EEO employer. All qualified applicants will receive consideration without regard to race, religion, age, national origin, sex, marital status, prior military service or mental or physical disability.
CLINICAL SYSTEMS;; CTMS, EDC, IVRS, EPRO.