Project Manager - Senior Project Manager

September 3

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Litigation Support Services • Deposition Services • Court Reporting • Records Retrieval • Realtime Reporting

501 - 1000

💰 Debt Financing on 2016-09

Description

• Provides operational support to Project Directors (PD). • Responsible for day-to-day management of project activities and deliverables. • Serves as a liaison with the sponsor and vendors across all functional areas of the project. • Assists in managing the project and ensuring that the quality of interactions and communications across the project are consistent with the sponsor and company expectations. • Provides guidance to CRAs, COS, and PS in the planning, implementation, and closeout of clinical research projects. • Serves as a point of contact for issue escalation. • Serves as a study contact for Sponsor and project vendors. • Develops key study documents, including but not limited to, Project Management Plans, Monitoring Plans, Informed Consent Forms, Case Report Forms, Study Reference Manuals/Regulatory Binders and source document templates, as applicable for study needs. • Reviews or oversees review of monitoring trip reports, if applicable. • Manages vendors, including implementation and coordination of vendor’s Scope of Work, if applicable. • Manages and provides oversight of study budget and timelines. • Identifies, resolves, or escalates issues involving study timelines and deliverables. • Develops, implements, and oversees enrollment plans and strategies. • Oversees system development, ensuring suitable fit for the protocol. • Collects, tracks, and reports established Key Performance Indicators such as query resolution, safety data collection or issues, drug reconciliation/shipment, site and patient enrollment, protocol deviations, etc. • Identifies and establishes the suitability of study investigators and their investigative sites and liaises with them to ensure compliance with all necessary study requirements, approvals, and agreements. • Ensures study conduct in accordance with appropriate SOPs, ICH/GCP Guidelines and local regulations. • Supports and works closely with the Business Development team. • Participates in customer audits and regulatory inspections. • Assists with vendor management on assigned project(s). • Collaborates with Quality Assurance when CAPA or deviations are necessary to be documented/initiated. • Manages project budget and scope, including scope changes. • Reviews and approves project level, site level, customer invoicing, and vendor expenses, as needed. • Identifies, quantifies, and communicates changes in scope. • Manages changes to the project scope. • Leads Internal, External, and study-related meetings. • Develops study risk management and planning. • Manages revenue activities with little support needed.

Requirements

• A minimum of 5+ years of experience in clinical research or equivalent in education and experience. • Relevant experience as a CRA preferred. • A minimum of 7+ years of experience in clinical research or equivalent in education and experience (for Senior Project Manager Level). • At least 3 years project management experience overseeing multiple full-service projects simultaneously, preferably in a CRO environment. • Study planning and set-up, maintenance, and close-out experience. • Must have a solid understanding of clinical research operations including GCP, regulatory requirements, and operational procedures. • Ophthalmology experience preferred. • CRO experience strongly preferred. • Highly customer service oriented and have creative initiative with a positive attitude. • Have an understanding and share the organizational values of developing and maintaining good relationships internally and externally. • Quality of interactions reflects emphasis on relationships. • Possess the ability to work in a fast-paced environment and easily adapt to changing priorities. • Excellent team management and communication skills (written and verbal), strong problem-solving skills, and be detail oriented. • Advanced skills in computer operation, spreadsheet creation/maintenance, and word processing are essential. • Proficiency in some software system(s) as appropriate for needs of department required. • Have an understanding of financial terminology and project financial management. • Have an understanding of contractual management.