Pulmovant - Senior Clinical Trial Associate
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Requirements
• BA/BS degree with at least 2 - 4 years’ clinical trial management experience, or advanced degree (MS) with at least 2 years’ clinical trial management experience • Must have strong knowledge of ICH/GCP guidelines • Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring • Strong experience in management of CROs and other vendors • Essential • Abilities • Proven project management skills and study leadership ability required • Must have excellent interpersonal, written and verbal communication skills, and administrative skills • Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project • Ability to “roll up your sleeves” and individually contribute results to a research and development effort • Ability to travel up to 25%
Responsibilities
• Coordinate and update clinical study timelines, enrollment metrics, and other study metrics in collaboration with the Clinical Lead • Provide monitoring oversight by reviewing monitoring schedules, metrics and reports. May oversee or manage clinical documentation and reports • Accurately update and maintain clinical systems within project timelines • Oversee TMF Quality Review for study team, complete TMF QC for each study collecting, quality review and submitting documents to the TMF. • Performing QC of TMF as appropriate. • Participate in developing study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables • Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance • Participate in preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team • Work on study feasibility assessments and selection of countries and sites for study conduct • Review and track study invoices against executed scope of works • Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors. • Generate, finalize and distribute study team agendas and meetings. • All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOP’s
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