Position Purpose

Under the guidance of Headquarters Clinical Quality Management Lead,  Director, the HQ CQM will oversee clinical quality management within the  Therapeutic Area (TA) supporting Clinical Trial Teams (for in or  outsourced trials) to proactively embed quality into Client sponsored  trials, ensure adequate vendor oversight for outsourced trials and  address quality issues as needed. The HQ CQM will be responsible for  development of Quality Plans to implement Quality by Design within  Clinical Development Programs, using a risk-based approach and  collaborating in implementation and executing of the Quality Control  activities at Headquarters (e.g. through central monitoring) as well as  in the Global Clinical Trial Operations countries (e.g. through targeted  Quality Control Visits (QCVs) at selected sites). They will work with  employees from all areas within and outside the Global Clinical Trial  Operations and will manage and/or co-lead key initiatives in Clinical  Research.

Organizational Relationships

• Reports to EP Line Management with day-to-day project work direction from Client

Primary Duties

Overarching Responsibilities:

• Quality Management subject matter expert who provides real-time,  proactive advice and guidance on procedures and issues relating to  Quality, Compliance and Global Processes related to clinical development  program management, clinical trial activities and vendor oversight

• Ensures creation of the Quality Plan and performs quality data  review for Clinical Development Programs that are prioritized according  to the Book of Business and in agreement with Clinical Sciences and  Study Management Heads and Clinical Therapeutic Area Heads

• Collaborates with HQ CQM Lead to facilitate appropriate quality  issue escalation and resolution in accordance with applicable change  management processes

• Complete training assigned by Client and/or EP, as necessary,  including general training requirements, SOPs, and system and process  related training

• Adhere to EP and Client SOPs and processes

Audit and Inspection Support:

• Develops and maintains Story Boards for Clinical Development  Programs and pivotal clinical trials to implement a risk based  mitigation approach in view of inspection readiness

• Supports the Global Inspection Management group, as part of the  preparation support teams for trial-related sponsor and/or site related  inspections

• Supports the development of responses to audits and inspections and  ensures appropriate Corrective and Preventative Actions (CAPA)  implementation

• Ensure that all actions and commitments are implemented in a timely manner

• Escalates issues to HQ CQM Lead from discussions/meetings with  other functional areas (i.e. Quality and Continuous Improvement, Quality  Assurance, Global Clinical Trial Operations)

Quality Signal Detection:

• Supports Therapeutic Area staff with in depth knowledge of current audit and inspection trends across and within programs

• Develops, implements and analyzes TA specific holistic quality  plans (risk based approach) to detect quality signals before they are  identified as audit observations and/or inspection findings

• Trends known quality issues, coordinates global and regional investigations

• Develops and manages targeted QCV, including the analysis and  development of appropriate action plans in agreement with defined  thresholds

Quality Signal Analysis

• Provides processes, systems and knowledge needed to proactively  disseminate known and potential quality issues from local/regional to  global perspective

• Support Quality and Continuous Improvement (QCI) Management and  Therapeutic Area staff by providing an ongoing consolidation and current  overview of known issues

Quality Issue Prevention

• Deploys and maintains global Quality Information management tools  (e.g. Story Boards) to track and trend issues as well as manage them  through their implementation life-cycle

• Implements a Quality by Design approach from initial Protocol through Clinical Study Report

• Provides input and approve trial specific monitoring plans

• Supports qualification and quality management of global vendors

Training and Education

• Bachelor Degree or equivalent in relevant health care area

• A minimum of 5 years of relevant experience in clinical research  including direct field monitoring experience or management/oversight of  such individuals with demonstrated record of accomplishments

• Deep knowledge and understanding of Clinical Development Programs,  Clinical Trial processes as well as quality management and control tools  is required

• Experience in Therapeutic Area, specifically related to design of  trials, therapeutic area specific clinical assessments and medical  practice

• Direct experience in general quality management, GCP Auditing or GCP Inspections

• Experience in delivering effective Corrective and Preventive Actions (CAPA) management solutions

• Superior oral and written communication skills in an international environment

• Excellent project management and organizational skills

• Excellent teamwork and leadership skills, including conflict resolution expertise and discretion

• Ability to leading cross-functional teams of business professionals

• Ability to analyze, interpret, and solve complex problems

• Ability to think strategically and objectively and with creativity and innovation

• Ability to proficiently interact with all levels of management and exert influence to achieve results