Job Information
Catalyst Clinical Research LLC Senior Project Manager- Oncology in Boston, North Carolina
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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