Senior Clinical Project Manager-Oncology - Catalyst Clinical Research LLC

As a Senior Project Manager - Oncology, you will be responsible for the routine cross-functional operations of assigned studies for one or more clients or management of a portfolio of functional projects, with minimal or no supervision. You will act as the team leader, ensuring that assigned studies are delivered successfully, on-time, within budget, according to the sponsor/CRO expectations and with the highest level of quality possible.

Position Qualification Requirements:

Education: 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.

Experience:  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.

Required Skills: 

• 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%.

Position Responsibilities/Accountabilities:

• 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.

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