Project Quality and Risk Lead (Late Phase)

Parexel International Corporation; King of Prussia (Montgomery County); Remote; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Project Quality and Risk Lead to enhance their clinical research initiatives. This role focuses on ensuring first-time quality and robust risk management while maintaining compliance and patient safety. You will collaborate with operational teams, providing quality oversight and expertise. The position offers a dynamic environment where you can leverage your analytical skills and adaptability to manage complex projects effectively. Join this forward-thinking organization to contribute to impactful health outcomes and advance your career in a supportive and growth-oriented culture.

Qualifications

• Experience in clinical research and risk management.
• Knowledge of ICH-GCP principles and root cause analysis methodologies.

Responsibilities

• Provide quality expertise to support operations and clients.
• Coordinate Critical to Quality (CtQ) identification and risk evaluation.

Skills

Interpersonal Skills

Analytical Skills

Communication Skills

Risk Management

Adaptability

Attention to Detail

Complexity Management

Education

Bachelor's Degree in Life Sciences

Relevant Experience

Job description

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.

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.