Responsibilities include: contribute to the design of clinical pharmaceutical trial studies. Develop and maintain project timelines, documents and communication tools to review (or analyze) project cost, scope, deliverables, and quality. Assist in the preparation and/or review of proposals, contracts, presentations, and other relevant documents for prospective and current clients in the life sciences industry. Organize and lead meetings and other clinical project related meetings and activities with cross-functional teams. Read, understand and train the project team on clinical trial protocols of specific therapeutic areas, case report forms (CRFs), clinical study electronic data capture (EDC) like Medidata rave, Inform, etc., and other applicable documents corresponding to the ICH GCP guidelines and FDA regulations. Ensure compliance to federal regulations (FDA) as well as ICH/GCP guidelines in addition to the organization's policies and sops. Works closely with the clinical trial project team to ensure complete understanding of the study/project objectives. Keep track of current resources to ensure adequate staffing is available to meet project deliverables and milestones. Escalate/communicate study related issues internally and with the client in a timely manner. Develop and maintain knowledge of wide therapeutic areas, industry regulations to ensure best practice across all project related activities. Support the entire clinical project life cycle. Identify and track issues, risks, dependencies, efficiencies, and critical path objectives. Develops and maintains project management documents and tracking tools essential to all aspects of managing clinical studies. Coordinate resource allocation on designated projects for the vita data sciences team. Contribute to the writing and presentation of scholarly articles resulting from clinical trial studies performed by the team.
Must have a Master’s degree in Regulatory Affairs, Clinical Trials Management or a related field. Remote work option available
