***MUST HAVE PHARMACEUTICAL INDUSTRY EXPERIENCE***
Position Summary: The Coordinator will be responsible for management and oversight of the day-to-day operations of clinical trials and studies. This position will ensure all work is conducted in accordance with SOPs, policies, good clinical practices, and applicable regulatory requirements. This position will be responsible for ensuring clinical trials and studies meets quality and timeline metrics. This position requires familiarity and understanding of drug product and clinical trial life cycle. This position also requires knowledge in biological sciences, strong organizational, management, interpersonal skills, and familiarity with a variety of the field’s concepts, practices, and procedures.
Essential Duties and Responsibilities:
Oversees Clinical Coordinator task assignments and ensures prompt completion of tasks
Manage deliverables, track and ensure timely reporting
Initiates, completes, and reviews study specific documents
Monitor’s study activity and works as a liaison between the sponsor and CROs to track progress and completion of studies
Works with CROs to coordinate and manage sample logistics and testing
Works with the document management team as appropriate to transfer documents in a timely manner
Performs other duties and responsibilities as assigned.
Supervisory Responsibilities: This position does not supervise employees.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education, Experience and Certifications: Requires a bachelor’s degree in biology or other relevant fields with 1-2 years of experience in program management, clinical trial coordination, and/or BioPharma preferred. Understanding of pharmaceutical industry activities and development processes also preferred.
Language Skills: Must have strong oral and written communication skills. The ability to write in-depth proposals and technical reports that require knowledge in the biological sciences, clinical trial and drug product life-cycle, and detail project structure, procedures, and outcomes is critical. Must be proficient in Microsoft Office software (Word, Excel, PowerPoint, Project and Outlook). Ability to effectively present information in one-on-one and group settings.
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