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The Opportunity
Description
We're looking for a Clinical Program Manager, working in Pharmaceuticals and Medical Products industry in 40 Landsdowne Street, Cambridge, Massachusetts, 02139, United States.
Job description:
- Manage Therapeutic Area Programs of a highly complex nature and/or high risk programs including, multiple indications, data safety monitoring boards, endpoint review committees as well as those requiring the coordination of multiple vendors.
- Serve as a strategic GCP quality resource providing GCP technical guidance recommendations to development teams.
- Maximize effectiveness and efficiency in the use of available resources in conducting clinical compound support quality assurance activities.
- Provide GCP QA leadership to drug development teams.
- Act as a quality expert to provide GCP compliance interpretation, consultation, training, and recommendations.
- Coach, educate and collaborate with external sites and cross functional staff in global regulatory readiness activities and responses in support of successful marketing applications.
Our Client Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success Requirements:
- B.S. in Science, Nursing, or related scientific field
- 7 years of experience in the pharmaceutical or biotechnology industry with 5 years of GCP-related Quality Assurance experience
- In Depth knowledge of the applicable global GCP regulations, Good Clinical Practices, ICH Guidelines
- Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity
- Strong knowledge and experience in key Key Therapeutic areas
- Strong written and verbal communication skills
- Able to present with influence to Sr Management and Quality Leadership
- Strong and respectful negotiator and influencer
- Demonstrated proficiency in conflict prevention and resolution
- Able to manage multiple complex projects, and demanding timelines
Preferred Requirements:
- ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional - GCP certification preferred
What Do You Think? Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
