The Clinical Trial Manager (CTM) is the lead project manager for trials conducted within the CRO services division of ProSciento. S/He will work cross-functionally with data management, regulatory affairs, clinical development, operations, and CRA services to ensure that studies are conducted per 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 include the following. Other duties may be assigned at the company’s sole discretion:
– Perform, as required, protocol review, site identification and selection, and drug supply management.
– Liaise with data management, regulatory affairs, CRA services, and other departments as applicable during study set-up and project management, as well as third party vendors.
– Coordinate projects; completes projects on time and within budget.
– Identify and select third party vendors, including laboratories, statistics vendors, biostorage vendors, or other CROs, and oversee their performance.
– Create and/or approve study documentation, including informed consent templates, protocols, case report forms, source documents, study plans, monitoring reports, and oversee clinical study reports development.
– Oversee and manage the collection and filing of essential trial documents (Trial Master File/TMF).
– Ensure the success of clinical trials by overseeing study conduct at multiple sites involved in each study.
– Participate in client study audits, as well as internal audits conducted by quality assurance for assigned projects.
– Represent ProSciento 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.
Bachelor’s degree in biological science or other related field plus one or more years of project management experience, preferably in a CRO. Experience monitoring or overseeing clinical trial sites and managing CROs 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. Ability to apply a range of negotiation techniques to achieve desired outcomes.
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 MS Office Word and Excel, preferably MS Office 365. Experience with SharePoint a plus.
Certificates and Licenses:
Project Management certification and/or willing to obtain certification.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk