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