Senior Project Quality and Risk Lead

Due to a growing portfolio, we are currently looking for Experienced Project Quality and Risk Lead to be based in Berlin with flexible working hours.

This position requires being at the at Clinical Unit (in Berlin) initially 2 / 3 day per week as agreed with Line Manager.

Job Purpose :

The Senior Project Quality and Risk Lead assumes the lead 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 compliance.

The Senior Project Quality and Risk Lead I 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 - Project Quality and Risk Lead assigned to projects will collaborate closely with the broader PQRM groups and other quality teams.

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.

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 :

• Advanced level experience and understanding in any area or combination of either Phase II-III or Late Phase / IV clinical project management and demonstrable experience in Quality or Risk Management activities are essential.
• Expertise with ICH-GCP principles
• Expertise in root cause methodologies (5-whys, fishbone diagram, etc.) and CAPA development
• Previous CRO experience is strongly preferred (applications from candidates with pharma experience will also be considered)
• English and German proficiency (written and oral)

Education :

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