Project Quality and Risk Lead (Late Phase)

The Project Quality and Risk Lead assumes the lead (with support of LM or Mentor) of Quality oversight responsibility and partners with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state.

Provide quality expertise to support operations, leadership and clients enabling the safeguarding and maintenance of patient safety, data integrity and regulatory complianceThe Project Quality and Risk Lead is acting as Risk Manager being responsible to coordinate Critical to Quality (CtQ) identification, risk identification, evaluation and controls. This position can also be part of a global project management teamProject Quality and Risk Lead assigned to projects will collaborate closely with the broader PQRM groups and other quality teams.

Skills:

• Good interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback.
• Developing analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions.
• Ability to develop professional, collaborative relationships both internally and with the client.
• Developing skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues.
• Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge.
• Ability to plan, organize, prioritize and manage workload with LM guidance, keeping the patient and client at the focus.
• Quality oriented with an attention to detail, taking initiative, ownership and accountability for deliverables.
• Developing the ability to manage the complexity of a matrix environment while valuing the importance of teamwork.
• Ability to travel about 20%

Knowledge and Experience:

• Experience in clinical research.
• Experience using root cause methodologies (5-whys, fishbone diagram, etc.)
• Experience in Real World Evidence (RWE) in Health Economics and Outcomes Research (HEOR) Studies is a bonus
• Knowledge of ICH-GCP principles
• English and Local country language (written and oral)

Education:

Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred

Parexel is proud to be a leading Clinical Research Organization with colleagues across the globe. As a member of our team, you’ll get to know your coworkers on a personal level. Have a question? A clinical research leader, project team member, technology “super user” or collaborator are a phone call away. Our clinical research teams meet regularly to have discussions in an open environment, allowing our team members to share their expertise and promote learning within the team. Management supports and encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level role, into line management, Quality, Project Leadership or a variety of other positions, Parexel prides itself on career opportunities for our employees.