ProSciento, Inc.

Clinical Study Manager

US-CA-San Diego
2 days ago

Overview

Summary: The Clinical Study Manager (CSM) will be the main operational interface with study sponsors, Contract Research Organizations (CROs), and any third parties during the launch, conduct, and closeout phases of a Clinical Research Unit (CRU) study. The CSM participates in and manages all administrative aspects of CRU clinical trials under the direction and supervision of the Senior Director, Clinical Study Management. The ideal candidate will have experience as a medical liaison, Clinical Research Coordinator, or as a Project Manager in a CRO or phase 1 facility working in the fields of diabetes, metabolism, or endocrinology. The CSM will perform duties in accordance with ProSciento’s values, policies, and procedures.

 

We are currently considering local candidates only.

Responsibilities

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

 

  • Manages all operational aspects for implementation of CRU clinical trial activities from study start-up through database lock, ensuring Good Clinical and Documentation Practices (GCP/GDP) and relevant Standard Operating Procedures (SOPs) are met.
  • Participates in the identification of study-related third party vendors and manages vendors; serves as the primary point of contact for sponsors, contracted CROs, and vendors; identifies potential risks and resolves issues.
  • Provides input into and/or develops study related plans such as study recruitment plan, communication plan, patient informed consent drafts, project plans, study timelines/ Gantt charts, site instructions for specimen collections, procedural operations manuals, and study drug order forms, as needed.
  • Reviews protocol deviations and source data for studies to ensure reliable, quality data are delivered.
  • Coordinates with sponsors or CROs on planning of the site initiation visit (SIV), dose escalation meetings, and teleconferences during study conduct and study close-out.
  • Tracks patient recruitment and progress to ensure study timelines are met.
  • Provides oversight of regulatory and/or investigator site files to ensure compliance with required regulatory and GCP quality standards and consistency with ProSciento SOPs.
  • Trains or manages oversight of training compliance of specific protocol related items.
  • Reviews protocol and may design study specific source documents and subject information handouts for designated studies.
  • Responsible for entering studies and visit schedules in the Clinical Trials Management System (CTMS).
  • As needed, administers Institutional Review Board (IRB) approved informed consent forms to subjects following GCP guidelines.
  • Other duties may be assigned at the company’s sole discretion.

 

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 scientific or medical related field; advanced level degree is a plus. Minimum 5 years of previous clinical research experience and/or Medical Assistant, LVN, or LPN, and/or an equivalent combination of education and experience.

 

Skills, Knowledge, and Abilities:

Ability to cope with scientific aspects and operational tasks. Leadership and people skills. Ability to work independently. Demonstrates strong initiative and is a problem solver. Thorough knowledge and understanding of GCP as it applies to clinical trials. Knowledge of applicable FDA rules, regulations, guidance documents, governing conduct of human clinical trials.

 

Language Ability:

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 write speeches and articles for publication that conform to prescribed style and format.

 

Math Ability:

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.

 

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

 

Computer Skills:

To perform this job successfully, an individual should have knowledge of the current MS Office Word and Excel.

 

Certificates and Licenses:

Certification as a Certified Clinical Research Coordinator (CCRC) with ACRP or certification as a Certified Clinical Research Professional (CCRP) with SoCRA, or willingness to obtain one of these certifications is strongly preferred.

 

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.

 

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 walk. The employee is occasionally required to stand.

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