- Client Liaison - Effectively communicate with internal and external customers as well as third party vendors, at leadership level
- Lead, facilitate and support the risk management process for high priority projects/Partnership/account using the available tools
- Lead and facilitate identification, investigation and remediation of high priority quality issues using available tools and methodologies. Provide oversight, transparency and tracking of quality issues for assigned projects
- Analyze key risk indicators and investigate risk signals by performing, reporting, and coordinating risk signal evaluations (RSE), including for high priority projects/partnership/account using dashboards, reports, metrics and other available tools
- Assist with preparations, conduct and response/action plan development for high priority audits/inspections and critical issues
- Provide expert quality advice as assigned, responding to consultancy requests and requests for SOP deviations using ICH-GCP, Parexel processes, regulatory requirements, applicable country requirements and input of appropriate subject-matter-experts
- Partner with Operational delivery teams to achieve and maintain inspection-ready state including story board oversight
- Develop and cultivate transparent quality relationships, while managing expectations with client quality representatives, including fulfilling the role of Portfolio Quality Lead (PFQL)
- Identify areas for continuous improvement of the Quality Management System by submitting feedback on processes, participating in process improvement initiatives as requested
- Maintain compliance with Parexel standards
- Mentor PQRLs as assigned
- Manage the relationship with Operations - Provide transparency to compliance with quality expectations (and defining those expectations) to Operational management (e.g., via metrics, reports, meetings attended / chaired)More about you Qualifications :
- Excellent interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback
- Strong 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
- Proven 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:
- A few 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-GxP principles and clinical trial or non-clinical trial regulations as applicable
- 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 disciple preferredA little about us:
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. If impact, flexibility, and career development appeal to you, Parexel could be your next home. -
Lead Software Engineer
před 5 dny
Rapid7 Prague, Česká republika Na plný úvazekRapid7's Metasploit team is building the future of the world's best-known software exploitation framework, working with the open-source community to help organizations around the world test their defenses and expose cybersecurity risk. We're looking for a lead engineer to help us ...
PV Project Quality and Risk Principal - Prague, Česká republika - Parexel
Popis
Due to a growing portfolio, we are currently looking for an experienced Quality and Risk Leads to be based in Czech Republic or Hungary with flexible working hours.
Your time here
The Quality and Risk Principal, 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 Quality and Risk Principal focuses on PV activities, is assigned to projects and/or accounts and collaborates closely with the broader PQRM groups and other quality teams.
What you'll do
Depending on study assignment and with support as necessary key accountabilities can include: