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The Quality and Risk Principal, when assigned as Project Quality and Risk Lead, assumes the lead of Quality oversight responsibility and has overall accountability for the execution of the Project Quality Life Cycle Plan (PQLC) within the projects.
The PQLC model delivers the services of PQRLs who provide expert quality advice to the project team regarding potential risks and the oversight of the risks through-out the lifecycle of the clinical trial Partner 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 compliance.
The Quality and Risk Lead principal 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 team. Quality and Risk principal assigned to projects and / or accounts will collaborate closely with the broader PQRM groups and other quality teams.
Skills :
Excellent interpersonal, verbal and written communication skills including effective listening, facilitating
group discussions, influencing without authority and providing appropriate feedback.
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.
- 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 independently, keeping the patient and client
at the focus.
Quality oriented with an attention to detail, taking initiative, ownership and accountability for
deliverables.
- Ability to manage the complexity of a matrix environment while valuing the importance of teamwork.
- Ability to travel 10% -15%.
Knowledge and Experience :
- 8- 10 years’ experience in clinical research
- Demonstrated experience in Quality or Risk Management activities
- Expertise in root cause methodologies (e.g. 5-whys, fishbone diagram, etc.) and CAPA development
- Expertise in Clinical Trial Risk Management
- Expertise with ICH-GCP principles
- English proficiency (written and oral)
Education :
Bachelor’s Degree or other relevant experience required. Life-science or other health-related
discipline preferred.
- Master’s Degree in a science, technology or industry-related discipline preferred
