Manager of Clinical Quality Assurance

 

This Direct Hire (NOT CONTRACT) position is available within a Malvern area Pharmaceutical leader.

 

Candidates must be local and a US citizen or green card holder.

 

Overview:

 

 

The Sr. Manager of Clinical Quality Assurance will supervise, manage and perform the auditing efforts that support the clinical development processes. This person will assist the CQA department in the advisory role to assure compliance of the Clinical Development departments with International Good Clinical Practice regulations and Guidelines (GCP).

 

 

Responsibilities:

 

 

Knowledge of International Good Clinical Practice regulations and the ability to educate staff in the application of regulations.

Perform Investigator site audits, document audits, database audits, clinical study report audits, clinical efficacy and safety document audits and internal process audits.

Team player with experience in leading and acts with integrity.

Must be able to interface in complex medical environments.

Ability to grow and develop a domain expertise in (one or more) therapeutic areas and audit areas i.e. clinical, stats, safety etc.

MUST be a Critical thinker. Must be able to develop collaborative relationships with all departments responsible for clinical drug development i.e. clinical operations, data management, safety, medical writing, biostatistics and regulatory affairs.

Partner in the clinical process i.e. Be able to develop and convey "Root? Cause" & "Risk Analysis" to clinical problems. Be more than just an Auditor.

Supervisory skills for personnel and projects.

 

 

Qualifications:

 

 

Up to 40-50% travel (with some international travel)

6-8 years experience within Quality Assurance and concentrating in clinical development areas in the pharmaceutical industry or a CRO.

Experience in auditing clinical trial sites, clinical trial data in all formats, internal clinical procedures.

Detailed knowledge of International Good Clinical Practice regulations and guidelines.

Good written and verbal communication skills. Detailed understanding of the clinical development process.

Ability to prepare for and make presentations to internal and external audiences. Ability to train on GCP's.

Ability to evaluate facts and decide on an appropriate course of action to comply with company and regulatory standards.

 

In exchange, Linx-AS's client offers an outstanding total compensation package that includes a salary of 80,000-90,000, health benefits, tuition assistance, 401K, stock options, paid time off, growth & advancement opportunities and much more.

 

Qualified candidates should forward a resume as a WORD ATTACHMENT and include a cover letter that states a specific salary requirement to: Recruiter@linxas.com

 

Qualified candidates will be contacted. No phone calls please.