ProSciento, Inc.

Clinical Project Manager II

US-CA-San Diego
2 days ago

Overview

Summary: The Clinical Project Manager II (CPM II) is the lead project manager for multi-site and investigator initiated trials conducted within the CRO services division of ProSciento. S/He will work cross-functionally as needed with clinical data management (CDM), regulatory services, clinical development, 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.

Responsibilities

Essential Duties and Responsibilities include the following. Other duties may be assigned at the company’s sole discretion.

  • Responsible for set up, conduct, and close-out of multi-center and investigator initiated trials (IIT), as well as specialized study projects.
  • Performs protocol review, site identification, feasibility, and selection, and drug supply management, and site qualification, as required.
  • Liaises with CDM, regulatory services, CRA services, pharmaceutical services, 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, protocols, case report forms, source documents, study plans, and monitoring reports, and oversees clinical study report development.
  • Identifies, selects, and coordinates requirements for third party vendors, including safety and specialty laboratories, biostatistics vendors, biostorage vendors, and/or data analytics, and oversees their performance.
  • Creates slides for Site Initiation Visit (SIV) and delivers or oversees the training.
  • Creates or oversees creation of additional study training materials and ensures all training is documented.
  • Owns oversight of the project; completes projects on time and within budget. Requests a change order to budgets and contracts when 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 (MVR).
  • Builds Trial Master File (TMF) for the project; oversees and manages the collection and filing of essential trial documents. Periodically reviews the TMF to ensure completeness and correctness of the contents.
  • Ensures the success of clinical trials by overseeing study conduct at all sites involved in each study.
  • 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.).
  • Represents ProSciento and sponsor at investigator meetings.

Qualifications

Qualifications:

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.

 

Education/Experience:

Bachelor’s degree in biological science or other related field plus two 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.

 

Language Ability:

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.

 

Math Ability:

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.

 

Reasoning Ability:

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.

 

Computer Skills:

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.

 

Work Environment:

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.

 

Physical Demands:

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.

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