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Job Details

Country Clinical Quality Manager

Company: Syneos Health
Location: Bucharest
Reference: PL - 1122
Closing Date: 23 Feb 18
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

CCQM oversees all CQM activities in the country. The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, inspections as well as Quality Control and local training activities.

Requirements:

Country Clinical Quality Manager

Bucharest, Romania

Full-time, permanent

 

Syneos Health is looking for CCQM tp join the team of one of our global Pharma clients in Romania.

CCQM oversees all CQM activities in the country. The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, inspections as well as Quality Control and local training activities.

Other responsibilities will include:

  • Local expert for ICHGCP and local regulations
  • Local expert for any qualityrelated local processes
  • Identifies process gaps / opportunities for process improvement and properly escalates
  • Local training point of contact and the liaison between local country operations and Learning & Development (L&D)
  •  In close cooperation with local country operations management, identifies / coordinates local training needs
  • Coordinates and oversees all Quality Control activities
  • Primary local point of contact for MRL Quality Assurance and Regulatory Agencies
  • Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management
  • Evaluates trends on Clinical Supply GCP Inquiries and incorrect management of clinical supplies
  • Leads local vendor qualifications and requalifications of locally selected vendors and supports solving of quality issues with locally selected vendors
  • Supports implementation of divisional compliance initiatives and reporting at the local level

Qualifications and experience:

  • Bachelor's Degree or equivalent in relevant health care area.
  • A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments.
  • Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required
  • Demonstrated experience leading crossfunctional teams of business professionals.
  • Solid track record of initiating, planning and delivery of projects and knowledge of project management practices
  • Ability to analyze, interpret, and solve complex problems

The employment will come through Syneos Health will full benefits. We have a comprehensive benefits package and offer highly competitive remuneration.

 

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.

 

 

Apply for this job: Country Clinical Quality Manager

Contact Information:

Address:  Poland (Polska)
Ul. Nowogrodzka 68 02-014 Warsaw (Warszawa)

Poland
Website:  Visit Our Web Site

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