Clinical Project Manager - United States
Iterum Herapeutics (company)
The Clinical Project Manager will be responsible for the planning and management of the operational aspects of clinical trials. This position provides coordination and support across all trials to ensure consistency in administrative processes and that the trials are conducted per established policies, procedures, regulations, and Good Clinical Practice (GCP). The Clinical Project Manager manages all phases of the trial process from proposal through inspection. This role also works closely with Finance and Accounting to ensure appropriate alignment and compliance with clinical study budgets.
The main responsibilities of this role include, but are not limited to:
- Executes the clinical study in accordance with the project clinical development strategy and timelines.
- Serves as a “go to” for CRAs and CTAs for questions regarding trial administration.
- Reviews and approves study related plans generated by CROs and vendors.
- Documents processes to enable turnkey operations when new trials are initiated.
- Obtains and reviews all required essential documents necessary for study initiation.
- Maintains accurate and timely sponsor/site correspondence and communication.
- Manages escalation of study related issues and communicates as appropriate with management and other functions.
- Actively builds relationships with departments and management to create a collaborative environment.
- Establishes, maintains, and updates various databases for tracking purposes.
- Ensures the timely shipment of all study materials (including protocols, study logs, study binders, etc.) and oversees returns and in-house reconciliation.
- Evaluates site and study performance metrics against agreed upon budget, deliverables and timelines.
- Reviews and processes vendor/site payments.
- May be responsible for extracting/exporting the results of studies, test results and data entry.
- Other tasks, as assigned by the project lead and/or VP Development Operations.
- Up to 20% domestic and/or international travel may be required.
Training and Education :
- B.A. or B.S. in the health sciences or equivalent experience required
- Master’s Degree preferred
- A minimum of 5-7 years of experience in a clinical operations role within a pharmaceutical company or CRO or similar organization.
- Project management experience.
- Pharmaceutical or medical device industry experience.
- Previous experience managing large or complex clinical studies.
- Knowledge of applicable standards, regulations and ICH-GCP for clinical study conduct.
- Experience of coordinating people and time management.
- Demonstrated experience in computer skills including Microsoft Word, Excel, and basic templates.
- Makes independent choices and takes responsibility for own actions.
- Anticipates potential issues and prepares contingency plans with minimal oversight and within set timelines.
- Conscientious and precise in delivery of work even when under pressure.
- Collaborative and team oriented.
- Excellent oral and written communication skills.
- Exhibits a confident and influential approach.
- Understands customer needs.
- Excellent planning, organizing, interpersonal and leadership skills.