■Job Title: Clinical Trial Manager, Clinical Operations - Asia Pacific Region
■Location: Australia (Remote)
Supervision of Others:
? This position is not a supervisory role. No direct reports.
? This role oversees vendors and/or contractors
Position Summary (Overview of Role):
The Clinical Trial 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 (Essential Role Responsibilities):
? Provides regional Clinical Operational management across 1-2 Insmed Clinical Trials within the Asia Pacific region in compliance with GCP and all other relevant regulatory guidelines.
? Manages and supervises the operational aspects of Insmed’s 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 (Required and/or Preferred Skills, Experience and Education):
? 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.
? Experience in CRO, vendor and laboratory selection and oversight 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.
? Must have excellent communication skills (verbal and written).
? Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
? Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
? Domestic and/or International travel required (up to 20%) ? Non-smoker