Job Details

MANAGERs COMMENTS::::

• 10 +yrs. of industry experience (biotech/pharma/ CRO) with at least 8 years of QA and clinical trials.

• Experience in NDA FDA inspections (sponsor and site)

• Experience in quality management of global Phase III oncology trials clinical Trials MOST important +++ clinical trial quality control - important

Job description:

An opportunity exists for an ambitious professional to be part of the clinical operations team in support of client. Client is a biopharmaceutical company working to improve the lives of patients by discovering medicines to develop a pipeline of oncology therapies.

This position offers the right candidate a significant opportunity for career development and growth. The Clinical Quality Assurance Manager (CQAM) works closely with internal team members and vendors to ensure that clinical trials are conducted per study plans and are compliant with SOPs, ICH / GCP/ regulatory guidelines.

Primary Responsibilities include but are not limited to the following:

Create, implement, and uphold SOPs for the department of Clinical Operations.

Track of quality management activities

Participate in team and management meetings

Ensure all company clinical trials are following the clinical study plans and protocol

Develop company-wide Quality Management System to include SOPs and vendor oversight plans.

Develop individual quality oversight plans for each clinical trial to ensure there are adequate controls and then test the strength of the controls

Oversee the quality scientific and medical design of the protocol

Assist with regulatory agency and ethics committee submissions and meetings

Track and manage vendor audits

Anticipate, prevent, and address protocol, regulatory, and/or GCP non-compliance issues, should they arise

Orchestrate quality oversight of all study activities and provides risk mitigation strategies and process improvement feedback to project leaders and senior management

Reviews external and internal documentation routinely to ensure completeness, consistency and adherence to applicable standardized operating procedures

Confirms clinical trial study reports against source data for data accuracy, integrity and consistency

Supports the clinical operations and medical teams by providing input and oversight to GCP related activities

Works with vendors to ensure they meet or exceed quality obligations. Creates and maintains a list of approved clinical vendors

Conduct Quality Control of eTMF quarterly

Supervise quality assurance of data management and data listing audits for the study report

Participate in audits and support regulatory inspections related to GCP

Education and Skills Requirements:

BS/BA degree or equivalent (background in life sciences preferred). Advanced degree preferred.

10 +yrs. of industry experience (biotech/pharma/ CRO) with at least 8 years of QA experience

Experience in NDA FDA inspections (sponsor and site)

Experience in quality management of global Phase III oncology trials

Strong understanding of ICH, GCP and relevant regulatory requirements

Strong operations and management skills with attention to detail

Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project