Clinical Operations Manager 2

POSITION PURPOSE:

The Clinical Operations Manager 2 (COM 2) is a local and/or regional role that provides end-to-end operational support during the lifecycle of assigned Phase I-IV studies in achieving efficiency compliance and quality as well as project / study milestones. The COM 2 operates in line with Good Clinical Practices (ICH-GCP) applicable regulatory and legal requirements and Bayers standard operating procedures.

The COM 2 will be assigned work packages in areas of study start-up study support and site management activities. Work packages are allocated to the position holder according to skill set and capacity requirements in a flexible way. The COM 2 will acquire knowledge and be provided adequate training to support independent execution of work packages assigned.

A work package is any combination of the individual responsibilities listed below. Work packages are not fixed can be allocated per study and distributed within the team. Allocation and distribution of responsibilities must adhere to Bayers standard operating procedures including any requirements for independent review and oversight.

YOUR TASKS AND RESPONSIBILITIES:

• System Management:

• Ensure the completeness and quality of the electronic Trial Master File (eTMF) at both site and country levels including conducting Veeva quality checks maintaining the Essential Documents List (EDL) uploading documents and other eTMF administration support activities.
• Manage user access for various systems (Bayer/study vendor systems) and update information for vendor system access/portals including Interactive Response Technology (IRT) Central Lab SharePoint restricted areas and TEAMS channels.

• Document Preparation and Quality Assurance:

• Prepare project/study documents and conduct local quality checks including the standard Site Start-Up (SSU) package.
• Prepare updated study documents ensuring readiness for submission.
• Coordinate the processes for document translation scanning printing and stamping. Including coordinate SUSAR translation reconciliation tracking distribution etc.
• Act as the local archiving coordinator for site requirements.
• Maintain operational tracking and develop study metrics including quality metrics reporting and others study specific tracking systems based on country team needs.
• Study Supplies Coordination: Coordinate the provision return and destruction of study supplies including liaising with local vendors arranging Investigational Medicinal Product (IMP) returns and compiling destruction certifications and related documents.

• Financial Support:

• Counterpart to the Finance department to coordinate regional finance activities including financial systems activities process support and serving as the financial system contact for site management.
• Provide financial and payment support including managing investigator payments eg. payment allocation vendor payment and invoice processing.
• Support procurement process including Purchase Order (PO) creation and other related activities.
• Compliance Support: Assist with compliance processes related to Healthcare Professional (HCP) creation investigator meeting applications and external payments.
• Local Posting Coordination: Coordinate local posting activities in accordance with APAC Health Authority requirements.
• Drive process optimization and simplification through task reallocation and centralization. Support the implementation of new processes to enhance operational efficiency.
• Post-Site Close-Out Activities: Complete relevant activities following site close-out visits such as ensuring the provision of End of Study PDF (EOSPDF) and other related tasks.
• Support the interview and hiring of new Clinical Operations Specialists (COS) and Clinical Operations Expert (COE) provide training and mentor new/junior staff.
• Provide expertise in non-project activities.

• Quality

• Proactively identify and communicate issues taking appropriate action to prevent recurrence of identified deviations. Ensure timely and comprehensive resolution of issues that may affect compliance or the quality of study related activities or data.
• Contribute to the preparation conduct and follow-up of Site Audits and Regulatory Inspections to ensure a successful outcome.

WHO YOU ARE:

• Healthcare related Bachelors degree or equivalent.
• Over 5 years of experience with Clinical operations or in the healthcare field pharmaceutical industry or clinical research / development.
• Understanding of clinical development and global operating processes of drug development as well as in-depth knowledge of ICH-GCP and international regulations
• Effective written and verbal English communication skills. Professional level of Japanese and/or Korean is a plus
• Oral presentation & interpersonal skills.
• Awareness & understanding of cultural and regional differences.
• Planning and organization time management prioritization.
• Be able to work independently; have critical thinking and issue resolution
• Thrives in ambiguous and collaborative environments and embraces change.

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