*Candidates who has experience as Clinical Operations Lead/ Leader, with QI/ Audit/ Inspection management experience or equivalent role/ responsibilities experience.

*Candidates with Clinical Trial QC/ QA experience from CRO or Pharma

*May consider offer higher title (Principal) based on the experience and ability for the role.

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

Key Accountabilities:

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.

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.
• ConsultSMEs includingother qualityexperts when necessary to resolve.
• Independently review and investigate possible project-level SOP deviations as requested by project teams.

Partner with project teams to achieve and maintain inspection-ready state including story board oversight

• Provide guidanceon maintaininginspection-ready documentation for assigned projects.
• Review/update of story boards for assigned projects as part of inspection preparation, where applicable.
• Encourage project team to use story board to record pre-developed response to a situation not explained through the TMF.
• Review story boards for completeness periodically to ensure inspection-readiness.
• Proactively identify gaps in documentation encouraging project team to document via project-level 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 Portfolio Quality Lead, perform client-level risk and issue management.
• As Portfolio QualityLead,provideclient-level quality oversight serving as a point of escalation, communicating pertinent information to account leadership as necessary.
• As Portfolio Quality Lead, develop/revise quality agreement as necessary.
• Define metrics for reporting quality performance against plan.

Identify areas for continuousimprovement 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.

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.

Mentor PQRLs and EP Quality Specialist as needed

• Serve as an integration partner to facilitate induction to PQRM.
• Establish formal, documented plan for each new hire assigned.

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

• As Risks Manager, to lead and facilitate robust project-level risk management, along with data management, safety, delivery, and other areas 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 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 facilitate QI team 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 (SME).

Analyze key risk indicators and investigate risk signals by performing, reporting, and coordinating risk signal evaluations for assigned projects using dashboards, reports, metrics, and other available tools

• Navigate dashboards to identify risk signals.
• Investigate signals by performing associated Risk Signal evaluations (RSE) using available tools.
• Communicate areas of risk to project team providing RSE data and other supporting information.
• Expertly facilitate identifying the potential root cause.
• Assist team in developing robust mitigations plans.
• Assess effectiveness of mitigations plans.
• Serve as subject matter expert for Risk Signal Evaluations as assigned.

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

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

Skills:

• Very good interpersonal, verbal, and written communication skills including effective listening, facilitating group discussions, influencing without authority, and providing appropriate feedback.
• Superior analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming, and imagining alternatives and assessing the effectiveness of actions.
• High ability to develop professional, collaborative relationships both internally and with the client.
• Very good skills 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.
• Highly quality oriented with an attention to detail, taking initiative, ownership, and accountability for deliverables.
• Advanced ability to manage the complexity of a matrix environment while valuing the importance of teamwork.
• Ability to travel 10% - 15%.