Medical Affairs Project Manager

As a Medical Affairs Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

This role provides global, regional or complex local management of a clinical trial (s) (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned project(s) at the country level for end-to-end project management including start-up, execution, close-out, analysis and reporting. Further, services will ensure the teams operational activities are in line with country specific regulations and trial teams are delivering high quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements. Partners with the Clinical Program Leader (CPL), Clinical Operations Head (COH), Global Clinical Trial Assistant (GCTA MAO), and other Global Trial Leaders (GTL) to ensure overall study delivery at the country level.

What you will be doing:

• Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.
• Escalates corrective and preventive actions (CAPA) to GTL and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners.
• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target and works with GCO/CRO staff in the set up and coordination of Investigator meetings, if applicable.
• Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required. As required, manages the local study drug supply
• Contributes to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates. This includes creating, reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.

You are:

• Bachelor’s degree or equivalent required, preferably in Life Sciences.
• 8 years of clinical research experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
• Proficient in speaking and writing Chinese and English. Good written and oral communication skills as appropriate.
• Flexibility and ability to manage study teams in a virtual environment.

Why ICON?Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.