Manager QA Clinical in El Segundo, CA at ConsultNet

Date Posted: 11/10/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/10/2019
  • Job ID:
    19-02060

Job Description

Manager QA ( Clinical Trials)
El Segundo, CA
Direct Hire
Pay: DOE

The position will be responsible to assess compliance with standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols.

Responsibilities include performing audits; internal systems, and of clinical trial sites. Audit findings are required to be summarized in a written report format according to SOPs and monitored for appropriate resolution. Audit findings are presented in an objective professional format, to the auditee.

This role participates in the development, implementation and maintenance of the corporate GCP Quality Management System and training program.

This is a cross-functional position that works with personnel in other departments, particularly Clinical Operations, in a collaborative nature as a QA on regulatory topics and interpretations.

Strong communication skills (written and verbal), with the ability to build internal and external relationships including interactions with clinical investigators and their staff concerning GCP matters, contract research organizations, and clinical laboratories.

REQUIRED COMPETENCIES
Complete understanding and application of ICH GCP R2
CQA or other audit certifications is a plus
Knowledge of TMF or electronic document management systems is a plus


ESSENTIAL FUNCTIONS

Assure Corporate compliance with SOPs and GCP regulations.
Conducts Quality Oversight of all study activities and provides risk mitigation strategies.
Lead and coordinate diverse Audits and Compliance visit monitoring activities.
Conduct follow-up activities to assure that non-compliance issues are addressed with a satisfactory resolution.
Read, understand, interpret, and apply regulations, guidance documents, and study protocol requirements to clinical studies.
Participate in solving GCP compliance issues.
Maintain a working knowledge in the specific areas related to GCP compliance.
Maintain all associated department spreadsheets, tracking of audit findings, and audit files as applicable.
Contributes to the development and review of SOPs and other controlled documents (forms, templates, work instructions)
Perform qualification, and routine compliance audits of clinical sites and clinical suppliers (CROs, phase 1 units, IRBs, translators, depots, etc.)
Performs extensive quality reviews of monitoring reports, on-site activities and electronic data capture (EDC). Reviews and approves controlled clinical trial documentation.
Assist in the development and implementation of pre-approval inspection readiness plans at investigative sites.
Prepares required documentation to support audit activities including; audit plans, audit reports, audit certificates and corrective action plans .
Represents QA department at internal and external meetings supporting clinical programs.



Be a part of the ConsultNet difference. As a leading national provider of IT staffing and solutions, ConsultNet delivers exceptional services to startup, midmarket and Fortune 1000 companies across North America. Since 1996, we've partnered with clients to create rewarding opportunities for our consultants, successfully building teams that have surefire results.
In the past two years alone, we have placed more than 1,500 consultants in contract, contract-to-hire, or direct placement opportunities. We understand communication is key to finding the right job that matches your skills and career goals. For us, it's not just the work that we do; it's how we do the work. Our breadth of offerings extends to multiple IT positions in major markets throughout the country, see more at www.consultnet.com