Project Manager II

ProSciento, Inc. is a company specializing in clinical research services, and they are seeking a Project Manager II to lead trials within their CRO services division. The role involves managing project timelines, overseeing study conduct, and liaising with various departments to ensure compliance with client expectations and regulatory standards.

Responsibilities:

• Performs protocol review and schedules kick-off meetings
• Liaises and assists with Data Management, Regulatory Services, CRA Services, Pharmaceutical Services, medical writing, medical monitors, and other departments as applicable during study set-up, project management and oversight, and project close-out
• Creates and/or approves study documentation, including informed consent templates, project plans, case report forms, and monitoring plans and reports, and oversees Clinical Study Report (CSR) development
• Coordinates requirements for third-party vendors, including safety and specialty laboratories, biostatistics, and/or data analytics, and liaises with budgets and contracts for proposal development. Oversees vendor performance
• Creates slides for Site Initiation Visit (SIV) and delivers or oversees the training
• Liaises with the site(s) recruitment department(s), to ensure adequate subjects are available for screening and enrollment
• Creates or oversees creation of additional study training materials and ensures all training is documented
• Owns oversight of the project and requests a change order to budgets and contracts when the project scope changes
• Plans and leads teleconferences with client and/or third-party vendors relative to project performance, status updates, and issue resolution
• Oversees scheduling of monitoring visits and reviews Monitoring Visit Reports (MVRs)
• Coordinates dose escalation meetings and participates in data reviews
• Builds the electronic Trial Master File (eTMF) for the project; oversees and manages the collection and filing of essential trial documents. Periodically reviews the eTMF to ensure completeness and correctness of the contents
• Coordinates with Principal Investigator (PI)/site staff, as applicable, during study start-up and oversight activities and to ensure appropriate subject oversight, protocol adherence, and query resolution
• Participates in client study audits, as well as internal audits conducted by quality assurance for assigned projects
• Collects and reports study metrics (enrollment, query rates, issues, etc.)
• Responsible for set up, conduct, and close-out of multi-center trials, as well as specialized study projects
• Supports creation of high-level study timelines for proposals
• Performs protocol review, site identification, feasibility, and selection, drug supply management, and site qualification, as required
• Coordinates with CRAs to ensure Pre-Study Visits (PSVs) are conducted and reviews reports to confirm each identified site is qualified for the study
• Ensures the success of clinical trials by overseeing study conduct at all sites involved in each study. Periodically schedules teleconferences with all CRAs participating in the trial to ensure monitoring alignment and relay project changes as applicable
• Participates in data review to identify trends
• Represents ProSciento and sponsor at investigator meetings
• May mentor and/or oversee the work of other PM staff. May include supervisory activities

Requirements:

• Bachelor's degree in biological science or other related field and/or a combination of education and experience
• Preferably two or more years of project management experience for Level I
• Preferably four or more years of project management experience for Level II
• Experience monitoring or overseeing clinical trial sites are required
• Experience monitoring or overseeing clinical trial sites and managing service providers are required
• Thorough knowledge of GCPs
• Strong project management skills
• Experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations
• Solid financial acumen to manage project budgets
• Managing studies at clinical research sites is a plus
• Project Management certification and/or willingness to obtain certification
• MBA a plus