Project Quality and Risk Lead

Provide quality expertise to support operations, leadership and clients enabling the safeguarding and maintenance of patient safety, data integrity and regulatory compliance
The Project Quality and Risk Lead is acting as Risk Manager being responsible for coordinating Critical to Quality (CtQ) identification, risk identification, evaluation, and controls. This position can also be part of a global project management team
The Project 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 skills 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 (mandatory)
• 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 disciplines 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 is 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.