Clinical Data Management

Fladger Associates
Published
July 31, 2022
Location
Foster City, CA
Category
Job Type

Description

Foster City, CA
Contract Duration: 6-18 months
Rate: Negotiable
Salary: NA $

Responsibilities:

  • Excellent employment opportunity for a Clinical Data Management in the Foster City, CA area.
  • Onsite: (subject to the vaccine mandate)
  • Hybrid, 2 3 days on site and remainder will be remote
  • Primarily responsible for the business, operational, and compliance aspects of drug discovery, development, and marketed products at Company.
  • Clinical data managers work collaboratively with internal and external colleagues and vendors to support Company's business objectives by ensuring the accurate and timely acquisition of diverse clinical data through efficient CRF/eCRF design, edit specifications, and query resolution processes.
  • Project Involvement
  • May lead a study or group of related small studies.
  • Demonstrates the ability to lead a study (ies)/project(s) with minimal supervision.
  • Serves as a point of contact for study management team.
  • Key Differentiating Contributions
  • Assists in implementing routine activities involving CDM interaction with other study management team members.
  • Reviews study protocols and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner.
  • Identifies, tracks, and resolves routine queries and issues.
  • The point of contact for Clinical Research regarding data management issues.
  • Demonstrates ability to identify problems early and communicate escalation issues appropriately.
  • Works collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics and others such as Clinical Research, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.
  • Demonstrates a general understanding of each assigned protocol, critical tasks and milestones.
  • Ensure completeness, accuracy and consistency of routine clinical data and data structure.
  • Assists in the implementation of routine clinical data management process with vendors including data entry, data quality checking, data transfer and reporting.
  • May lead in the preparation of CRF/eCRF design.
  • Reviews study protocol and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner.
  • Identifies, tracks, and resolves routine queries.
  • Utilizes routine reports to track study progress and ensures timeliness and quality expectations are met.

Experience:

  • 3 years of experience and a BS Degree.
  • 1 years of experience and a MS Degree or PhD
    Excellent verbal and written communication skills and interpersonal skills are required.
  • The ability to problem-solve and have people/project leadership skills.
  • Knowledge of FDA/EMA regulations, support of needs for NDA and other regulatory submissions, and familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems.
  • Demonstrates understanding of project timelines and metrics to ensure databases are delivered to set timelines.

Apply
Drop files here browse files ...

Related Jobs

Senior Software Engineer   Fremont, CA new
August 13, 2022
August 13, 2022
August 13, 2022
August 13, 2022

Author: