Parexel International Corporation
Project Quality and Risk Lead (Late Phase)
Parexel International Corporation, King Of Prussia, Pennsylvania, United States, 19406
Job Opening: Project Quality and Risk Lead Due to a growing portfolio, we are currently looking for
Project Quality and Risk Leads
to be based in Serbia, Croatia, or Turkey with flexible working hours.
Please make an application promptly if you are a good match for this role due to high levels of interest. 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. Responsibilities include providing quality expertise to support operations, leadership, and clients, safeguarding patient safety, data integrity, and regulatory compliance. The Lead acts as Risk Manager, responsible for coordinating Critical to Quality (CtQ) identification, risk evaluation, and controls. This role may also be part of a global project management team. The Project Quality and Risk Lead assigned to projects will collaborate closely with 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 to identify potential and real issues, investigate root causes, brainstorm, and assess the effectiveness of actions. Ability to develop professional, collaborative relationships internally and with clients. Skill in interpreting, synthesizing, inferring, evaluating, and extracting pertinent data to identify risks, trends, and issues. Adaptability to changing environments, quick thinking, dealing with ambiguity, and learning new tasks applying routine knowledge. Ability to plan, organize, prioritize, and manage workload with LM guidance, keeping patient and client focus. Quality orientation with attention to detail, initiative, ownership, and accountability for deliverables. Ability to manage complexity in a matrix environment while valuing teamwork. Willingness to travel approximately 20%. Knowledge and Experience:
Experience in clinical research. Experience using root cause analysis methodologies (e.g., 5-whys, fishbone diagram). Experience in Real World Evidence (RWE) and Health Economics and Outcomes Research (HEOR) studies is a bonus. Knowledge of ICH-GCP principles. Proficiency in English and the local country language (written and oral). Education: Bachelor's Degree or relevant experience required. Life sciences or health-related discipline preferred. Parexel is proud to be a leading Clinical Research Organization with colleagues across the globe. We foster an open environment for discussion, learning, and career growth, supporting progression into senior roles, line management, Quality, Project Leadership, or other positions.
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Project Quality and Risk Leads
to be based in Serbia, Croatia, or Turkey with flexible working hours.
Please make an application promptly if you are a good match for this role due to high levels of interest. 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. Responsibilities include providing quality expertise to support operations, leadership, and clients, safeguarding patient safety, data integrity, and regulatory compliance. The Lead acts as Risk Manager, responsible for coordinating Critical to Quality (CtQ) identification, risk evaluation, and controls. This role may also be part of a global project management team. The Project Quality and Risk Lead assigned to projects will collaborate closely with 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 to identify potential and real issues, investigate root causes, brainstorm, and assess the effectiveness of actions. Ability to develop professional, collaborative relationships internally and with clients. Skill in interpreting, synthesizing, inferring, evaluating, and extracting pertinent data to identify risks, trends, and issues. Adaptability to changing environments, quick thinking, dealing with ambiguity, and learning new tasks applying routine knowledge. Ability to plan, organize, prioritize, and manage workload with LM guidance, keeping patient and client focus. Quality orientation with attention to detail, initiative, ownership, and accountability for deliverables. Ability to manage complexity in a matrix environment while valuing teamwork. Willingness to travel approximately 20%. Knowledge and Experience:
Experience in clinical research. Experience using root cause analysis methodologies (e.g., 5-whys, fishbone diagram). Experience in Real World Evidence (RWE) and Health Economics and Outcomes Research (HEOR) studies is a bonus. Knowledge of ICH-GCP principles. Proficiency in English and the local country language (written and oral). Education: Bachelor's Degree or relevant experience required. Life sciences or health-related discipline preferred. Parexel is proud to be a leading Clinical Research Organization with colleagues across the globe. We foster an open environment for discussion, learning, and career growth, supporting progression into senior roles, line management, Quality, Project Leadership, or other positions.
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