
Clinical Scientist

Position Purpose
This position is a coordinator/support role for the scientific conduct of a protocol.
Organizational Relationships
• Reports to EP Line Management with day-to-day direction from Client
• Liaises with cross-functional lines as appropriate
• May interact with internal and external stakeholders (study sites, committees, etc.) in support of clinical study objectives
Primary Duties
• Assists the Program Lead and study team with the scientific conduct of clinical studies
• May have specific task assignments for a single study or across multiple studies, e.g. adjudication support, medical monitoring, data management deliverables, preparation of meeting materials, safety and medical monitoring
• 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
Training and Education
• BS/BA with 4+ years of relevant career experience or MS with 3+ years of relevant career experience
• Pharmaceutical and/or clinical drug development experience.
Headquarters Clinical Quality Managers

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