Leads clinical trials within a CRO, serving as the primary client interface. Coordinates cross-functional teams, vendors, clinical sites, monitoring, study documentation, training, budgets, timelines, audits, eTMF maintenance, data reviews, and regulatory compliance. PM II responsibilities include managing multicenter and specialized studies, site feasibility and qualification, drug supply, investigator meetings, CRA coordination, trend analysis, and mentoring other project managers.
POSITION SUMMARY:
The Project Manager (PM) is the lead for trials conducted within the CRO services division of ProSciento and is the main interface between ProSciento and the client. S/He will work cross-functionally as needed with Clinical Data Management (CDM), Regulatory Services, Clinical Operations (CO), Budgets and Contracts, and CRA Services to ensure that studies are conducted per protocol and client expectations, on time, within budget, and according to FDA regulations and ICH GCP. Performs duties in accordance with company’s values, policies, and procedures.
*This role can be hired as a level I or level II based on the candidate's working experience and background.
DUTIES AND 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.).
All duties defined in level one, and in addition:
- 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.
JOB REQUIREMENTS / QUALIFICATIONS/EDUCATION:
Level I:
- 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. Experience monitoring or overseeing clinical trial sites are required. Managing studies at clinical research sites is a plus.
Level II:
- Bachelor’s degree in biological science or other related field and/or a combination of education and experience. Preferably four or more years of project management experience, preferably in a CRO. Experience monitoring or overseeing clinical trial sites and managing service providers are required.
KNOWLEDGE, SKILLS, AND COMPETENCIES REQUIRED
- Customer Focus: Dedicated to meeting expectations and requirements of both internal and external clients. Establishes and maintains effective relationships with customers and gains their trust and respect.
- Problem Solving: Uses rigorous logic and methods to solve difficult problems with effective solutions; is excellent at analysis; looks beyond the obvious and doesn't stop at the first answers. Solid analytical skills.
- Organizing: Can marshal resources to get things done; can orchestrate multiple activities at once to accomplish a goal. Uses resources effectively and efficiently.
- Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend to a broader range of activities.
- Priority Setting: Spends his/her time and the time of others on what’s important; quickly zeros in on the critical few and puts the trivial many aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.
- 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.
Certificates and Licenses
- Project Management certification and/or willingness to obtain certification. MBA a plus.
Working Conditions and Physical Effort
- The physical demands described here are representative of those that must be met by an employee to successfully perform essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close, distance and peripheral vision as well as depth perception and the ability to adjust focus. While performing the duties of this job the employee is regularly required to sit, talk, and hear. The employee is frequently required to stand; use hands to finger, handle, or feel and reach with hands and arms.
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