Senior Project Manager

February 13

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Catalyst Clinical Research

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Listen, Devise, Breakthrough

Clinical Operations Services • Clinical Resourcing/Staffing • Clinical Teams • Functional Service Provider

201 - 500

Description

• Responsible for the overall coordination and management of clinical trials from start-up through close-out activities. • Develop, implement and communicate project plans, monitoring plans, regulatory plans and all other applicable study materials. • Facilitate team training in accordance with the protocol and/or project requirements, including therapeutic, protocol specific and process training. • Direct all project staff across functional areas to facilitate study progress. • Develop study specific Standard Operating Procedures (SOPs) and other study-specific management tools as needed. • Oversee activities with respect to regulatory document collection and Trial Master File maintenance for applicable studies and directly assist with such activities as needed. • Work closely with Central Site Services and Clinical Operations team on initial investigator recruitment and evaluation by reviewing site feasibility questionnaires and investigator CVs. • Oversee negotiation, or may negotiate, of the site contracts and/or budgets as well as distribution of investigator grants. • Oversee the supply of Investigational Product and other study materials to sites. • Work with sponsor to determine and implement patient retention strategies as needed. • Assist with resolution of site and facility issues such as outstanding queries, overdue documentation, lab and study drug issues. • If part of the role, monitoring reports are received, reviewed and signed off per specified timelines as defined in the Monitoring Plan and/or applicable SOPs. • Ensure project documentation is complete, current, stored appropriately and audit-ready. • Develop and maintain a close working relationship with sponsor study management team. • Establish a strong working relationship with and act as a resource for investigative sites; troubleshoot site and patient concerns and critical project matters. • Communication: May serve as the primary liaison with the sponsor and project team for assigned studies. • Coordinate, plan and execute Investigator Meetings as needed. • May need support from a Senior Project Manager. • Lead internal project team meetings. • May lead sponsor project team meetings or collaborate with a Senior Project Manager. • Oversee the creation and distribution of study-specific newsletters as required. • Escalate issues and critical project matters in a timely manner to appropriate team members, senior management, and sponsor.

Requirements

• University/college degree (life sciences preferred) or certification in a related allied health profession from an appropriately accredited institution, such as nursing, medical or laboratory technology. • 7 years previous experience in a Project Manager role in a clinical research setting with a progression of increased responsibility over time. • Experienced managing oncology projects- working in either cell therapy or CAR-T. • Strong knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials. • Excellent written, oral communication and presentation skills. • Excellent interpersonal and organizational skills with demonstrated attention to detail. • Ability to read, write and speak fluent English. • Ability to build positive, productive client and team member relationships. • Demonstrated problem-solving capabilities, critical thinking, and analytical skills. • Good computer skills with good working knowledge of a range of computer applications. • Ability to meet deadlines, multitasks, and prioritize based on project needs. • Ability to make sound decisions based on available information. • Ability to work both in a team and independently. • Ability to lead team meetings and teleconferences and provide accurate and comprehensive minutes. • Ability and willingness to travel to investigator meetings, investigative sites and bid defense meetings, etc., up to 25%.

Benefits

• Competitive salary • Comprehensive benefits package • Opportunity for growth and advancement • Dynamic and collaborative work environment