Clinical Project Manager II
Summary: The Clinical Project Manager (CPM) is the lead project manager 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.
Essential Duties and Responsibilities will include the following. Other duties may be assigned at the company’s sole discretion.
- 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 Principle 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.).
Additional Duties and Responsibilities for CPM II
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.
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
CPM II Education and Experience:
Bachelor’s degree in biological science or other related field plus 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.
Skills, Knowledge, and Abilities:
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.
CPM III and above: Ability to apply a range of negotiation techniques to achieve desired outcomes. Knowledge of international regulatory requirements.
Certificates and Licenses:
Project Management certification and/or willing to obtain certification. MBA a plus.
Good communication skills, both verbal and written. Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Ability to solve practical problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
To perform this job successfully, an individual should have knowledge of the current MS Office Word, Excel, and MS Project. Experience with SharePoint a plus.
The work environment characteristics described here are representative of those an employee may encounter while performing the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually quiet to moderate.
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.