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.
Please note: ProSciento is only considering local candidates at this time.
Essential Duties and Responsibilities will include the following. Other duties may be assigned at the company’s sole discretion.
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 I Education and Experience:
Bachelor’s degree in biological science or other related field plus two or more years of project management experience. Experience monitoring or overseeing clinical trial sites 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.