Career Category

Job Description

Purpose of the role

• To oversight PMC studies according to the country specific requirement and country regulation
• To provide guidance on the implementation and conduct of post marketing commitment (PMC) studies from initial planning to close-out in accordance with local regulation and Health authority requirement
• Lead communication with health authority for all PMC studies to ensure regulatory requirements are met at local level
• Collaborate with cross functional stakeholders to ensure timely execution of PMC deliverables

Role Description

• Report to Local Medical director/ Evidence Generation Head (China only
• Local Medical role
• Collaborate with local Regulatory, local Safety, Global Clinical Program Management (GCPM) and any vendors

China PMC manager is responsible for:

• Provides guidance on the implementation and conduct of PMC studies in accordance with local regulation by supplying appropriate advice and consultation to LST (Local study team) and Clinical Study Team (CST) as below:
• Provide training to all relevant staff about PMC process and regulation
• Provide input on PMC study design and protocol development ensuring local regulatory requirements are considered
• Provide guidance on the site budget according to China sites’ specific requirements
• Provide expertise to the LST/ CST to help identify risks/issues related to PMC studies and advise on the best way to address these risks/issues
• Provide guidance for Ethics/IRB documents and translations to country representatives to support submissions and responses to Ethics questions
• Ensure PMC report submissions to the local health authority are completed within specified timelines and with adherence to Amgen SOP’s
• Support the LST/ CST to drive effective decision making by providing knowledge of PMC regulations and local health authority requirements
• Support the management of vendors (CRO) to the required standards for both in-house and outsourced studies, as applicable.
• Provide local insights/expertise regarding decisions to proceed to Site Evaluation Visits (SEV’s) for potential sites in collaboration with the local medical team and global study operations-site management (GSO-SM).
• Ensure PMC regulation and standard practices are considered in the development of the country level timelines as well as site and patient
• enrollment estimates.
• Attend CST and designated sub-team meetings as appropriate

Key Activities

• Provide guidance to the study team on planning and management of PMC execution in accordance with the local regulation.
• Contribute to study level goal setting.
• Provide feedback on the protocol during the study design process to ensure the PMC reporting requirements are met
• Provide input on the identification, selection, set-up, and management of vendors
• Contribute to the execution of the feasibility process in collaboration with the CST
• Collaborate with local study team (LST) to provide guidance on site evaluation and site selection plans
• Review and provide input to develop study specific documentation (e.g. study specific training documents, Ethics/IRB documents)
• Provide guidance on the best strategy for recruitment plans and support the implementation of these plans
• Provide best practices for site engagement in PMC studies to support timely data entry and query resolution
• Support the resolution of cross-functional study-specific issues by ensuring PMC regulations and health authority requirements are considered
• Ensure CST is aware of reporting requirements for all PMC reports 
• Review data tables and provide feedback to ensure all reporting requirements are considered
• Review PMC reports and provide feedback for required content, acceptable format and completeness
• Review translated PMC reports for accuracy and acceptable verbiage
• Support internal audit and inspection activities and contribute to CAPAs globally
• Support regulatory agency inspection readiness activities
• Participate in cross-functional task forces and process improvement groups
• enrollment estimates.
• Attend LST/ CST and designated sub-team meetings as appropriate
• Ensure annual report of each PMC study to be submitted to NMPA on time and meet the regulatory requirement.
• Review and ensure proper content of all PMC reports
• Manage the timeline, quality control process, publishing and required approvals of all PMC reports
• Ensure PMC report submissions to NMPA are completed within specified timelines and with adherence to Amgen SOP’s

Basic Qualifications

• Master’s degree & 3 years of directly related experience or equivalent

OR

• Bachelor’s degree & 5 years of directly related experience or equivalent

Preferred Qualifications

• 7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience in oversight of external vendors (e.g. CRO, Medical Writing, etc.)

Knowledge

• Advanced knowledge of global clinical trial management
• Clinical trial processes and operations
• Extensive knowledge of local PMC regulations and guidelines
• Project and Program management including oversight of study deliverable, budgets and timelines
• Time, cost and quality metrics, Key performance indicators
• Relevant therapeutic knowledge

Key Competence

• Matrix team leadership
• Project Management
• Critical thinking and horizon scanning
• Problem solving
• Decision making
• Delegation skills
• Relationship Management and influencing skills
• Oral and written communication
• Time management
• Business English
• Organizational and planning skills
• Ability to work effectively in a team/matrix environment on multiple projects

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.