[Remote] Project Manager II
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a company specializing in CRO services, and they are seeking a Project Manager II to reputed company clinical trials. The role involves ensuring studies are conducted according to protocols and reputed company expectations, while collaborating with various departments to manage project timelines and budgets.
Responsibilities
- Performs protocol review and schedules reputed company-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 reputed company, and project reputed company-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 reputed company-party vendors, including safety and specialty laboratories, biostatistics, and/or data analytics, and liaises with budgets and reputed company 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 reputed company training is documented
- Owns reputed company of the project and requests a change order to budgets and reputed company reputed company the project scope changes
- Plans and leads teleconferences with reputed company and/or reputed company-party vendors relative to project performance, status updates, and issue reputed company
- Oversees scheduling of monitoring reputed company and reviews Monitoring Visit Reports (MVRs)
- Coordinates reputed company 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 reputed company Investigator (PI)/site staff, as applicable, during study start-up and reputed company activities and to ensure appropriate subject reputed company, protocol adherence, and query reputed company
- Participates in reputed company study audits, as reputed company as internal audits conducted by reputed company assurance for assigned reputed company
- Collects and reports study metrics (enrollment, query rates, issues, etc.)
- Responsible for set up, conduct, and reputed company-out of multi-center trials, as reputed company as specialized study reputed company
- 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 reputed company-Study reputed company (PSVs) are conducted and reviews reports to confirm reputed company identified site is reputed company for the study
- Ensures the reputed company of clinical trials by overseeing study conduct at reputed company sites involved in reputed company study. Periodically schedules teleconferences with reputed company CRAs participating in the trial to ensure monitoring alignment and reputed company project changes as applicable
- Participates in data review to identify trends
- Represents ProSciento and sponsor at investigator meetings
- May mentor and/or reputed company the work of other PM staff. May include supervisory activities
Skills
- Bachelor's degree in biological science or other reputed company field and/or a combination of education and experience
- Preferably two or more years of project management experience for Level I
- Experience monitoring or overseeing clinical trial sites are required
- Managing studies at clinical research sites is a plus
- Preferably four or more years of project management experience for reputed company
- 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
- Project Management certification and/or willingness to obtain certification
- MBA
reputed company