CRA Manager - Taiwan & Hong Kong
GSK
Taipei, Taiwan
5天前

Our CRA Manager will provides leadership, oversight and manages the activities of Clinical Research Associates (CRAs) to ensure the delivery of all clinical studies, across all therapy areas (Rx and Vx) to the required quality standards, GSK written standards and ICH GCP.

This role will provide you the opportunity to lead key activities to progress your career.

Key Responsibilities

  • Accountable to lead a team of CRAs by providing study related training, coaching and mentoring for all staff and in addition, line and performance management for internal staff.
  • Responsible for effectively managing capacity utilization of internal and insourced CRAs / SCRAs, ensuring alignment of capabilities with study requirements, resource availability and business priorities.
  • Contribute to overall management of clinical research within the LOC via involvement in applicable leadership teams to ensure consistency and utilisation of resources and best practice.

  • Responsibility to engage with the FSP partner and ensure they deliver according to agreed timelines and quality expectations.
  • Accountable to ensure the completion of all monitoring deliverables for all studies assigned to the LOC to agreed timelines, budget and quality standards.
  • The CRA manager works with the CRAs / SCRAs to resolve and escalate issues that may impact study delivery.

  • Responsible to identify and share best practices, standardizing across the LOC / region and representing local / regional clinical operations on global and cross functional initiatives.
  • Recruitment and development of GSK permanent CRAs. Responsible for oversight of GSK and insourced CRAs.
  • Collaborates with the relevant country and / or central teams for determining the feasibility of conducting protocols with reference to patient population, study complexity, and relevant resource.
  • Maintains oversight of selection of suitable hospitals / clinics / investigators.

  • Ensures that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are met for both GSK and insourced CRAs.
  • Provides issue management and resolution and co-monitoring support for CRAs at sites to ensure productive, efficient study delivery.

  • Ensures the quality and integrity of clinical studies conducted in the LOC by taking on appropriate business management monitoring activities.
  • In collaboration with Clinical Operation Head and Local / Regional Risk and Management Monitoring identifies management monitoring process checks linked with CRA activities that require inclusion in the local quality plan
  • Evaluates capabilities and competencies of internal staff, identify and coordinate implementation of personal development plans for direct reports
  • Assists with audits / inspections of local clinical operations department & study / sites in the country.
  • Continuous development of knowledge in the areas of GCP, internal company guidelines , SOPs , new monitoring technologies and capabilities Serves as an expert in ICH GCP and GSK written standards for internal and insourced CRAs.
  • Available and willing to travel as job requires
  • Basic Qualifications

    We are looking for professionals with these required skills to achieve our goals :

  • Bachelors degree or equivalent. Any general science degree e.g. life science, medicine, clinical research, pharmacy etc.
  • A minimum of 5 years’ experience in clinical operations is required with a preference of 2 years of line management experience.
  • Profound operational knowledge of clinical research with experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug / vaccine development process.
  • Good understanding of and experience with use of project management. Knowledge or ability to acquire expertise regarding use of multiple systems / tools related to clinical studies.
  • Stakeholder management skills required as the role includes interactions with senior stakeholders at a central or LOC level.
  • Strong written and verbal communications skills are required in English and local language.

  • Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment.
  • Works in an environment that is constantly evolving with new processes and systems, internally and externally and the CRA manager needs to be able to adapt to these changes quickly and efficiently.

  • Demonstrates track record in quality decision-making and problem resolution that impacts study / program direction. Recognizing potential risks and can implement effective mitigation strategies.
  • Recognizes and reacts to changes that impact a study and / or program or practices, and has the skill set to assess the appropriateness of protocol / plans in the local environment.
  • Preferred Qualifications

    If you have the following characteristics, it would be a plus :

  • Masters of Science or equivalent
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