Quintiles – Nederland

Senior Clinical Site Monitoring Quality Specialist (G31) / Quality Manager (G32)-1417887

Description

Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 29,000 employees conducting business in approximately 100 countries. We helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market.

Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com

PURPOSE

Implement and deliver the agreed upon Global Quality Control plan for the country which includes risk management, to assis Clinical Operations to deliver a better compliance with relevant ICH, GCP, country regulations and guidelines. In addition to the Global plan, contribute to the development of and will be responsible for implementation and delivery of specific regional/local initiatives as defined and agreed upon with Regional Quality Management. Provide advice and support to local Clinical Operations, including Project Managers and other key local stakeholders with regard to quality control, risk assessment and management, and corrective actions.

RESPONSIBILITIES

• Implement and deliver the Global Quality Control Plan on a country level; this will include:

o planning and executing the Quality Control activities within the country

o risk identification through quality controls and on site quality assessment visits

o corrective actions and guidance for improvement

o monitoring compliance with the global strategy and the impact of the initiatives in the country

• Contribute to the development and implementation of a Regional/Country Quality Control Plan and Risk Management

Program adapted to local needs and monitor implementation and delivery.

• Provide advice and support to LOCAL Clinical Operations, including Project Manages, Line Managers, LOCAL Learning and Development trainers, and Quality Assurance on all aspects of compliance, SOP development and customer requirements and work in close cooperation with operational teams to review, escalate and manage the quality issues, assist in corrective action plans preparation and implementation. This will include assistance during audits and regulatory inspections and partnering with QA in case of suspicion of fraud or misconduct.

• Ensure adequate communication with the LOCAL Heads of Clinical Operations to get them engaged in the deployment of the strategy.

• Act as the conduit between the local offices within the region/country and Quality Assurance Services, attending

meetings/teleconferences as needed to exchange performance related data and information on quality issues and

initiatives.

• Inform AD Clinical Operations Quality Management, Head of Clinical Operations in the country and Quality Assurance Services of significant quality issues as they arise, in accordance with appropriate operating procedures/work instructions.

• Prepare periodic reports to AD Clinical Operations Quality Management on quality related matters, risk assessments and local quality improvement initiatives.

• Assume a customer facing role in the country for quality related issues.

• Act as the primary contact for Quality Assurance for local / country matters.

• Perform any other reasonable tasks as required by the role.

All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Sound working knowledge of medical terminology, clinical monitoring procedures (SOPs), GCP, FDA regulation and

quality performance initiatives and processes

• Knowledge of National and International Regulations and Drug Development process

• Knowledge of CRO or Pharmaceutical industry operations

• Knowledge of Quintiles corporate standards and SOPs

• Good organizational, interpersonal and communication skills

• Good judgement and decision-making skills

• Strong influencing and negotiation skills

• Strong computer skills including Microsoft Office and Clinical Management applications

• Demonstrated ability to work in a matrix environment

• Excellent problem solving skills

• Ability to travel extensively within the region/country

• Ability to lead and motivate a clinical team

• Ability to establish and maintain effective working relationships with coworkers, managers and clients

Qualifications

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s degree in life sciences or equivalent nursing qualification with a minimum of 6 years experience in Clinical Monitoring including at least 2 years experience in a role equivalent to CTL ; or equivalent combination of education, training and experience

• Fluent in English.

PHYSICAL REQUIREMENTS

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech

• Extensive use of keyboard requiring repetitive motion of fingers

• Regular sitting for extended periods of time

• Occasional travel

Primary Location: Great Britain
Other Locations: Switzerland, Portugal, Italy, Spain, Belgium, France, Germany, Netherlands, Ireland
Organization: GBR02 – UK Product Development

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