ProSciento, Inc.

Clinical Data Manager

US-CA-San Diego
2 days ago

Overview

Summary: The Clinical Data Manager, under the direction of the Associate Director, Clinical Data Management, is responsible for the daily clinical data management (CDM) operations of ongoing studies managed by ProSciento. The Clinical Data Manager will concentrate on good data management documentation practices and apply ProSciento procedures to provide excellent service to our sponsors. 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.

 

Clinical trials/research, including associated equipment and computer systems:

  • Leads the process of Case Report Forms (CRF)/Electronic Case Report Forms (eCRF) development for a study.
  • Leads the development and maintenance of the CDM plan.
  • Designs and tests studies in ProSciento’s data management system for use on paper-based CRF and eCRF studies.
  • Creates study-specific data entry instructions and conventions.
  • May participate in data entry from paper CRFs as needed.
  • Creates and maintains the data validation specifications.
  • Designs edit checks within the ProSciento data management system that conform to the data validation specifications.
  • Performs discrepancy management within the ProSciento data management system.
  • Routinely reviews data issues with internal site staff to minimize discrepancies.
  • Updates study database (paper CRFs) and assists Data Entry Associates with updates (eCRFs) according to discrepancy responses.
  • Develops data listings from the data management system to perform data review that may result in discrepancies.
  • Creates and maintains study status reports for tracking CRF/eCRF completion, discrepancy management, and other study metrics as needed.
  • Performs medical coding of adverse events and concomitant medications.
  • Manages and QCs data received from external vendors.
  • Prepares and QCs internally-generated data for review by CRAs and for transfer to sponsors or CROs.
  • Supports the Associate Director, Clinical Data Management, in the oversight of CROs for any outsourced studies.
  • Attends team meetings as needed to represent CDM interests.
  • Assists in the development, maintenance, and monitoring of CDM policies, standards, and practices.
  • Reviews protocols and provides input relevant to data management issues.
  • Provides input for the development of project specific timelines and budgets.
  • Trains on department specific Standard Operating Procedures (SOPs) and Work Instructions (WIs).      

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 life sciences or mathematics and/or formal or on-the-job training in clinical trial methodology and Good Clinical Practice (GCP) plus five or more years of experience in direct data management experience at a CRO, pharmaceutical, or biotechnology company and/or an equivalent combination of education and experience. Experience writing SOPs and training documentation.

 

Skills, Knowledge, and Abilities:

Technical competency using data management systems, especially EDC systems. Understanding of US and international regulatory mandates and guidance for clinical research including FDA/ICH-GCP. Demonstrated ability to manage a complex workload and prioritize tasks based on program goals. Ability to work quickly and independently and as a strong team player.

 

Language Ability:

Ability to read and interpret documents such as safety rules, SOP’s, WI’s, procedural manuals, governmental and clinical regulations, and similar documents. Excellent oral, written and interpersonal communication skills with the ability to communicate effectively to employees and Management groups and in group meeting settings.

 

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. Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

 

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 intermediate knowledge of the current MS Office Suite.

 

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.

 

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 and talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stoop, kneel, crouch, or crawl.

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