Clinical Research Manager

Parexel International Corporation; Auckland; On-site; NZD 80,000 - 120,000; Full time

Job summary

An established industry player seeks a Clinical Research Manager to oversee end-to-end project management for clinical trials. This role is pivotal in ensuring compliance with international standards and internal policies while driving performance and quality. You'll be the main point of contact, collaborating with various stakeholders and managing study execution from feasibility to closeout. If you have a strong background in clinical research and project management, this opportunity offers a chance to make a significant impact in a dynamic environment. Join a team where your expertise can lead to groundbreaking advancements in clinical trials.

Qualifications

• 5-6 years of experience in clinical research, preferably with CRA experience.
• Bachelor's degree in Science required; advanced degree preferred.

Responsibilities

• Main POC for assigned protocols, ensuring compliance with regulations.
• Responsible for project management and performance tracking of studies.

Skills

Clinical Research

Project Management

Risk Management

Quality Control

Collaboration

Education

Bachelor's degree in Science

Master's degree, MD, or PhD

Tools

Clinical Trial Management System (CTMS)

electronic Trial Master File (eTMF)

Job description

The Clinical Research Manager (CRM) is primarily accountable for end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Primary Duties:

• Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT)
• Responsible for project management of the assigned studies
• Proactively plans/drives/tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out
• Accountable for performance for assigned protocols in country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally
• Performs quality control visits as required
• Reviews Monitoring Visits Reports (MVRs) and escalates performance issues and training needs to CRA manager and /or functional vendor and internal management as needed
• Responsible for creating and executing a local risk management plan for assigned studies
• Ensures compliance with Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and other key systems in assigned studies
• Escalates as needed different challenges and issues to Therapeutic Area (TA) Director / Clinical Research Director (CRD) / Clinical Quality Management (CQM) and or CTT (as appropriate)
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
• Country POC for programmatically outsourced trials for assigned protocols
• Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets)
• Shares protocol-specific information and best practices across countries/clusters
• Strong collaboration with local/cluster roles, experience in identifying and sharing best practices across clinical trials, countries, clusters
• Oversees accountability for country/cluster and site validations, site selection and recruitment in assigned protocols
• Lead and contribute to initiatives and projects adding value to the business and supporting the strategy
• Responsible for quality and compliance in assigned protocols in country
• Coordinate study Clinical Trial Coordinator (CTC), Clinical Trial Associates (CRAs), Clinical Operation Manager (COM)

Skills and Education:

• Bachelor's degree in Science (or comparable) required; advanced degree (Master's degree, MD, PhD) preferred
• 5-6 years of experience in clinical research
• CRA experience preferred
• Travel expectation is up to 30% of working time

#LI-REMOTE