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Senior Clinical Operations Manager for APAC

Job title: Senior Clinical Operations Manager for APAC
Contract type: Permanent
Location: Australia
Specialisation:
Salary: $100 - 150 k
Start date: 12-04-2021
Reference: en-64210 - PR/052181
Job Reference: 51981
Contact details: Sena Yamada
Contact email: Sena.Yamada@jac-recruitment.com
Job published: about 1 month ago

Our client, MNC Pharmaceutical company is looking for Senior Clinical Operations Manager.

 

Position Summary:

The Senior Clinical Operations Manager (APAC) is responsible for the day to day management and oversight of phase I-IV clinical trials in the Asia Pacific region in collaboration with a dynamic Clinical Sub-Team of cross-functional representatives.

Key responsibilities include management of activities from start-up through CSR, including but not limited to: development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets, management of third-party vendors for clinical services, close collaboration with investigators and site staff, and management of project timelines and deliverables.

 

Responsibilities:

  • Provides regional Clinical Operational management across 1-2 their Clinical Trials within the Asia Pacific region in compliance with GCP and all other relevant regulatory guidelines.

  • Manages and supervises the operational aspects of their clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites.

  • Reviews contracts/work orders to ensure integration of the Asia Pac region into the global program.

  • Manages vendor adherence to contractual obligations including proactively recognizing changes in scope and collaborating with senior management to ensure timely completion of change orders.

  • Monitors study metrics and Key Performance Indicators to ensure oversight of clinical trial progress.

  • Participates in SOP and process development activities for Clinical Operations functions.

  • Manages execution and adherence to program timelines.

  • Directly accountable for clinical trial execution, with a focus on site start-up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs, vendors and central labs.

  • Participates in investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.

  • Participates in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials.

  • Presents trial status and clinical operations strategy to project team and management.

  • Reviews and approves specific study documents (e.g. informed consent forms, study guidelines, operations manuals, training materials).

  • Approves action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.

  • Attends site visits to ensure oversight of CRO.

 

Position Requirements:

  • Bachelor’s degree in a scientific discipline required. Advanced scientific degree is preferred.

  • The candidate should have a minimum of 8 years in trial management with a pharmaceutical/biotechnology company.

  • Experience in clinical trial conduct in multiple phases of development across several therapeutic areas is required.

  • Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements and local regulations.

  • Demonstrated strong leadership skills and the ability to work successfully in a matrix team environment in a global setting.

  • Experience in the management across a development program and participation in NDA/sNDA filing is preferred.

 

We regret to inform applicants that only shortlisted candidates will be notified.

Thank you for your understanding.

 

JAC Recruitment Pte. Ltd.

EA Licence No: 90C3026

EA Personnel: R1984018

EA Personnel Name: SENA YAMADA