Project Manager II

ProSciento, Inc• US,

11h•$130,000 - $150,000

About The Position

The Project Manager is the lead for trials conducted within ProSciento’s CRO services division and serves as the main interface between ProSciento and the client. The role works cross-functionally with teams such as Clinical Data Management, Regulatory Services, Clinical Operations, Budgets and Contracts, and CRA Services to ensure studies are conducted according to protocol and client expectations, on time, within budget, and in compliance with FDA regulations and ICH GCP. The role performs duties in accordance with company values, policies, and procedures. This position may be hired at Level I or Level II based on the candidate’s experience and background. In addition to the duties applicable to Level I, a Level II Project Manager is responsible for setting up, conducting, and closing out multi-center trials and specialized study projects. The role may support creation of high-level study timelines for proposals, perform protocol review and site selection activities, manage drug supply, coordinate site qualification and pre-study visits, oversee study conduct across sites, participate in data trend reviews, and represent ProSciento and the sponsor at investigator meetings. The role may also mentor or oversee other project management staff, potentially including supervisory activities.

Requirements

Bachelor’s degree in biological science or another related field, and/or a combination of education and experience.
Level I: Preferably two or more years of project management experience.
Level I: Experience monitoring or overseeing clinical trial sites is required.
Level II: Preferably four or more years of project management experience, preferably in a CRO.
Level II: Experience monitoring or overseeing clinical trial sites and managing service providers is required.
Thorough knowledge of GCPs and strong project management skills.
Experience in clinical research, including strong working knowledge of ICH guidelines and FDA and IRB/IEC regulations.
Solid financial acumen to manage project budgets.
Project Management certification or willingness to obtain certification.

Nice To Haves

Experience managing studies at clinical research sites is a plus for Level I.
MBA is a plus.

Responsibilities

Review protocols and schedule kick-off meetings.
Coordinate with Data Management, Regulatory Services, CRA Services, Pharmaceutical Services, medical writing, medical monitors, and other departments during study set-up, management, oversight, and close-out.
Create and/or approve study documentation, including informed consent templates, project plans, case report forms, and monitoring plans and reports; oversee Clinical Study Report development.
Coordinate third-party vendor requirements, including safety and specialty laboratories, biostatistics, and data analytics; liaise with Budgets and Contracts on proposal development and oversee vendor performance.
Create Site Initiation Visit slides and deliver or oversee training.
Coordinate with site recruitment departments to ensure adequate subjects are available for screening and enrollment.
Create or oversee additional study training materials and ensure training is documented.
Oversee assigned projects and request budget and contract change orders when project scope changes.
Plan and lead client and/or vendor teleconferences covering project performance, status updates, and issue resolution.
Oversee scheduling of monitoring visits and review Monitoring Visit Reports.
Coordinate dose-escalation meetings and participate in data reviews.
Build and oversee the project electronic Trial Master File; manage collection and filing of essential trial documents and periodically review the file for completeness and correctness.
Coordinate with the Principal Investigator and site staff during study start-up and oversight to support subject oversight, protocol adherence, and query resolution.
Participate in client study audits and internal quality assurance audits for assigned projects.
Collect and report study metrics, including enrollment, query rates, and issues.
For Level II, set up, conduct, and close out multi-center trials and specialized study projects.
For Level II, support creation of high-level study timelines for proposals.
For Level II, conduct protocol review, site identification, feasibility and selection, drug supply management, and site qualification as required.
For Level II, coordinate with CRAs to ensure Pre-Study Visits are conducted and review reports to confirm site qualifications.
For Level II, oversee study conduct at all sites and periodically coordinate teleconferences with participating CRAs to align monitoring and communicate project changes.
For Level II, participate in data review to identify trends.
For Level II, represent ProSciento and the sponsor at investigator meetings.
For Level II, potentially mentor and/or oversee other PM staff, including supervisory activities.