Project Quality and Risk Manager

The Project Quality and Risk Manager may be assigned as Global Project Quality and Risk Lead (PQRL)/ Portfolio Quality Lead (PFQL) for large sized projects with complex challenging indications and/or involving multiple countries/regions, and/or for key customer accounts. As Global PQRL/PFQL, this role is expected to coordinate work with other regional PFQL/PQRLs. The Project Quality and Risk Manager is also required to contribute to management in developing work process optimization and provides operational leadership through mentoring new/junior members of the team.

The Project Quality and Risk Manager, 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 Project Quality and Risk Manager 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.

The Project Quality and Risk Manager assigned to projects and/or accounts will collaborate closely with the broader PQRM groups and other quality teams.

Key Accountabilities:

Accountability: Supporting Activities

Client Liaison

• Effectively communicate with internal and external customers as well as third party vendors
• Prioritize effectively and respond to urgent quality requests within team or from sponsor
• Serve as the point-of-contact for the client quality representatives for projects or accounts.
• Seek out opportunities to leverage relationships with clients for future sales

Lead, facilitate and support the risk management process for assigned projects/Partnership/account using the available tools.

• As Risk Manager, to lead and facilitate robust project-level risk management, along with data, safety, delivery and other risks as applicable
• Work with operational teams, functional leads and SMEs to identify, categorize, score and develop mitigations
• Confirm agreed mitigations have been integrated into functional project/partnership/account plans
• Assess effectiveness of mitigations with functional leads
• Encourage documenting lessons learned

Lead and facilitate identification, investigation and remediation of quality issues as assigned using available tools and methodologies.  Provide oversight, transparency and tracking of quality issues for assigned studies.

• Triage quality issues in electronic quality management system (eQMS) ensuring appropriate classification
• Participate in the initial assessment of Serious Breach of GCP
• Assist QI team members in developing containment actions
• Expertly lead QI teams to investigate root causes using various methodologies
• Facilitate development of robust corrective and preventive actions (CAPA)
• Support assessment of CAPA effectiveness as necessary with QI team and action owners
• Serve as eQMS subject matter expert

Analyze key risk indicators and investigate risk signals by performing, reporting, and coordinating inspection readiness checks for assigned projects/partnership/account using dashboards, reports, metrics and other available tools. 

• Navigate dashboards to identify risk signals
• Investigate signals by performing associated Inspection Readiness Check (IRC) using available tools
• Communicate areas of risk to project teams through IRC data analysis and other supporting information
• Expertly facilitate identifying the potential root cause
• Assist teams in developing robust mitigation plan
• Assess effectiveness of mitigation plan
• Serve as subject matter expert (SME) for IRC as assigned
• Contribute to PQRM team as a dashboard SME
• Define metrics for reporting quality performance against plan in collaboration with Project Lead and Functional Leads.

Assist with preparations, conduct and response/action plan development for audits/inspections as assigned.

• Support audit/inspection preparation including helping teams set priorities and reviewing key documents
• Provide onsite or remote support as needed, presenting Parexel Quality and QMS overviews, when necessary
• Review all audit/inspection responses prior to final QA review, if necessary
• Expertly lead team to investigate root causes using various methodologies
• Facilitate development of robust CAPA
• Serve as eQMS SME

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.

• Provide real-time quality expertise to enable project teams to deliver first-time quality
• Consult SMEs including other quality experts when necessary
• Independently review and investigate possible project/partnership/account-level SOP deviations as requested
• Represent Parexel Quality at client and internal meetings

Partner with Operational delivery teams to achieve and maintain inspection-ready state including story board oversight.

• Provide guidance on maintaining inspection-ready documentation for assigned projects/Partnership/account.
• Review/update of story boards for assigned projects Partnership/account.
• Encourage project team to use story board to record pre-developed response to a situation not explained through the TMF
• Proactively identify gaps in documentation encouraging project team to document via story boards where applicable

Develop and cultivate transparent quality relationships, while managing expectations with client quality representatives, including when needed fulfilling the role of Portfolio Quality Lead (PFQL).

• Lead quality-to-quality meetings as needed
• As PFQL, perform client-level risk and issue management
• As PFQL, provide client-level quality oversight serving as a point of escalation, communicating pertinent information to account leadership as necessary
• As PFQL, develop/revise quality agreement, as necessary

Identify areas for continuous improvement of the Quality Management System by submitting feedback on processes, participating in process improvement initiatives as requested.

• Identify changes in scope and liaise with Project Leader
• Provide feedback via the appropriate channel when gaps or issues are identified with Parexel processes.
• Propose ideas to PQRM leadership related to departmental efficiencies, potential improvements, or innovations.
• Review and provide feedback on quality SOPs as assigned
• Participate in, and provide feedback on any key PQRM initiative, as assigned

Maintain compliance with Parexel standards.

• Comply with required training curricula
• Accurately complete timesheet as required
• Submit expense reports as required by SOP
• Update CVs as required by SOP
• Comply with Parexel processes, ICH-GCPs and other applicable requirements
• Ensure backup coverage for out of office period and agreement with line manager for adequate oversight of work during absence.

Mentor PQRLs as assigned.

• Serve as an integration partner to facilitate induction to PQRM Department.
• Establish formal, documented plan for each new hire assigned.
• Design and provide training for PQRM as assigned.
• Provide feedback to line management on progress.

Skills:

• Excellent interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback.
• Advanced analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions.
• Strong ability to develop professional, collaborative relationships both internally and with the client.
• Excellent skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues. 
• Highly adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge.
• Strong ability to plan, organize, prioritize and manage workload independently, keeping the patient and client at the focus. 
• Strong quality oriented with an attention to detail, taking initiative, ownership and accountability for deliverables.
• Excellent ability to manage the complexity of a matrix environment while valuing the importance of teamwork.
• Ability to travel 10% -15%.

Knowledge and Experience:

• at least 8 years’ of experience in clinical research (including CRA experience from CRO/ Pharma) from Australia. Local experience is a must.
• Clinical Operations Lead/ Leader with QI/ Audit/ Inspection management experience or equivalent role/ responsibilities are highly preferred. (Local experience)
• 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.