Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Job Nature & Scope: Key Working Relationships <ul><li>Internal contacts within client </li></ul>Global & Regional Team <ul><li>QA from R&D </li></ul><ul><li>Procedural & Process Management Network </li></ul><ul><li>Global LMS Administrator </li></ul><ul><li>Global PV enabling team </li></ul>Local Team <ul><li>Local Study Team Leaders and Local Study Team Members – Evidence Generation, China MA </li></ul><ul><li>GxP QMS, China MA </li></ul><ul><li>Head of Evidence Generation, China MA </li></ul><ul><li>Pharmacovigilance Personnel, China MA </li></ul><ul><li>Medical Excellence Manager, China MA </li></ul><ul><li>QC team member </li></ul><ul><li>External contacts with organizations outside client </li></ul><ul><li>Study team staff of Contract Research Organization </li></ul><ul><li>Study site staff </li></ul> Job requirements Acts Decisively <ul><li>Makes Effective Decisions Under Pressure: individual still makes effective decisions and can do so in the absence of complete information and when under pressure. </li></ul>Works Collaboratively <ul><li>Respects and Integrates Diverse Views: individual seeks input and demonstrates an appreciation for diverse views by incorporating them into decisions/ proposals. </li></ul>Results driven behavior <ul><li>Always maintain a focus on the objectives and anticipated outcomes of the clinical trial, ensuring that all components are effectively advanced to meet the established goals. </li><li>Adapt work strategies and plans with flexibility in response to trial progress and feedback on outcomes. Enhance the trial process to improve both efficiency and quality. </li></ul>Establish robust alliances with both internal and external stakeholders <ul><li>Establish and maintain close collaborative relationships with internal team members. Foster effective communication and collaboration among team members to facilitate the smooth progression of the trial. </li></ul><ul><li>Ensure consistent communication and coordination with external stakeholders. </li></ul><ul><li>Exhibit good teamwork and coordination skills in cross-departmental and inter-institutional collaborations. </li></ul>Self-motivation and adaptability <ul><li>Demonstrate a sense of self-motivation, exhibiting the capacity to actively and enthusiastically engage in clinical trial work. Be able to devise effective solutions for the complex and dynamic situations in clinical trials. </li></ul><ul><li>Demonstrate a commitment to continuous learning and skill acquisition to adapt to the ever-evolving landscape of clinical trial regulations and technologies. </li></ul> Academic / Professional Qualification <ul><li>Bachelor degree or above of medical/pharmaceutical background </li></ul> Working experience (No. of years / Job function / Business types) Essential <ul><li>At least 2 years working experience in clinical trial </li></ul><ul><li>At least 2 years quality management relevant experience </li></ul> <ul><li>At least 1 year proven training or coaching experience </li></ul>Desirable <ul><li>Procedural documents development experience </li></ul><ul><li>Clinical research experience within multinational pharmaceutical companies.</li></ul> COMPETENCIES (Skill / Knowledge / Technical / Training requirements) Skill <ul><li>Learning agility: swiftly acquire new knowledge and skills and apply effectively in practical works. </li></ul><ul><li>Presentation skills: confidently and fluently delivering training. </li></ul>Knowledge <ul><li>Experience of quality management in clinical trial </li></ul><ul><li>Excellent competence of GCP and clinical study procedure or pharmacovigilance </li></ul>Language ability <ul><li>Fluent oral and written English is essential. </li></ul>Computer literacy <ul><li>Proficient in the Microsoft Office software </li></ul> DUTIES & RESPONSIBILITES: Study onsite and remote QC activities <ul><li>Conduct onsite QC and remote QC as per QC plan requirement. </li></ul><ul><li>Draft related QC Report within timeline and keep the quality observations be notified to CPM and QC head. </li></ul><ul><li>Provide suggestion of CAPA and have a follow up if needed. </li></ul><ul><li>Conduct TMF quality checks for studies with documentation as per QC plan. </li></ul><ul><li>Conduct study level QC if needed (e.g., safety handling QC, HGR QC, etc.) </li></ul> Training delivery/support <ul><li>Lead/support the NEO training </li></ul><ul><li>Deliver /support the routine training/on-demand training for EvGen teams which are to emphasize the procedural key points or the update of global/local procedures. </li></ul><ul><li>Organize learning from QC checking, Audit and inspection for study teams which is aimed at increasing study team capability for study delivery. </li></ul>Supporting Audits & Inspections readiness <ul><li>Manage and supports activities during the preparation/ongoing/follow up phase of an audit or inspection. </li></ul><ul><li>Support finding management in VQV, CAPA development and implementation. </li></ul><ul><li>Case Sharing of results and training of local project team, if required. </li></ul>Vendor Management <ul><li>Coordinator the Operational Due Diligence (ODD) activity. </li></ul><ul><li>Support the vendor ODD by third party and follow the CAPA implementation status if needed. </li></ul><ul><li>Conduct the periodic vendor performance assessment and follow up with related CAPAs. </li></ul>SUSAR Line Listing management <ul><li>Sampling check to ensure the accuracy of monthly SUSAR line listing translation from third party </li></ul><ul><li>Delivery the qualified monthly SUSAR line listing to the project team in time. </li></ul>Other <ul><li>Keep compliance with regulatory, industry, client standard/policy and SOP requirements. </li></ul><ul><li>Complete other tasks assigned by QC head. </li><li></li></ul>

QC Manager (FSP)

Description

Parexel

Pipeline