Thermo Fisher Scientific zoekt een

VP, Centralized Monitoring (EMEA)

Barcelona, Spain; Milan, Italy

Job Description

In response to evolving delivery models, regulatory expectations, and industry standards, PPD clinical research services is expanding its centralized monitoring and data analytics capabilities.  As Head of Centralized Monitoring , you will be responsible for leading the strategic growth and transformation of this multifunctional team to drive excellence and enhance the operational efficiency and quality of clinical trials.

With a focus on Risk Based Quality Management, trial delivery and data integrity, the VP, Centralized Monitoring will grow a high performing leadership team globally, with the ability to deliver in the current environment and continually anticipating the future.

You will have significant impact across PPD, leading the development of vision, strategies and operational priorities for your department. You will explore and implement new technology and process. You will collaborate with internal and external stakeholders, build and refine client relationships and establish PPD’s position as a leader in this area.

Reporting to the Senior Vice President of Clinical Operations, you will be responsible for:

  • Building and leading a multifunctional group to provide Centralized Monitoring capabilities to meet evolving trial delivery, regulatory expectations and industry standards.
  • Driving data and digital innovation to continuously improve quality, increase speed of delivery and reduce cost to build best in class operations.
  • Collaborating with senior leadership across the business to define the strategic vision and oversee the deployment plan to realize this vision and embed new ways of monitoring to optimize operational delivery.
  • Ensuring awareness of trends in the industry and to track new capabilities and technologies to ensure Centralized Monitoring operates at the cutting edge of available technology.
  • Ensuring appropriate KPI's and Oversight metrics/measures are in place to track progress against targets/objectives.
  • Providing executive oversight to the Centralized Monitoring team and collaborate to ensure that future resourcing is appropriately defined, and clear plans are in place.
  • Supporting an environment for controlled risk-taking with high standards to ensure an innovative mindset is fostered and encouraged down through the organization.
  • Identifying better ways of serving the customer and driving more effective ways of working
  • Being an active member of the Clinical Operations senior leadership team, contributing to the strategic agenda by means of open dialogue to ensure successful delivery of the Clinical Operations strategic plan.

Qualifications, Skills and Experience:

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification (Masters preferred)
  • Previous clinical research experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years’ experience).
  • Central Monitoring or Risk Based Quality Management experience.
  • In some cases, an equivalency, consisting of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

  • Proven leadership skills with ability to grow and change organizations.
  • Significant experience in Clinical Operations and or Data Management within a pharmaceutical company or CRO
  • Understanding of regulatory environments and the principles of quality, safety, risk management and compliance (ICH and GCP).
  • Thorough understanding of all phases of drug development
  • Ability to drive complex initiatives from inception to completion.
  • Ability to work independently to execute strategic and tactical plans under tight timelines.
  • Ability to encourage, inspire and motivate employees to innovate and create change that will help grow and shape the future success of the business.
  • Ability to assemble and lead cross-functional teams toward a shared vision of success.

PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role:

  • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
  • Able to work upright and stationary for typical working hours.
  • Ability to use and learn standard office equipment and technology with proficiency.
  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
  • May require as-needed travel (~20%).

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