Project Quality & Risk Lead

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 10% - 15%

Knowledge and Experience:

• Experience in late phase clinical research.
• Experience using root cause methodologies (5-whys, fishbone diagram, etc.)
• Knowledge of ICH-GCP principles
• English and Lithuanian proficiency (written and oral)

Education:

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