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.
