Senior Specialist (Contractor), PM, Medical Research and Innovation

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POSITION SUMMARY:        

The role aims at managing study initiated by MAF, from study plan to close：

• Project manager is a person within Trial Co-ordination and site management responsible for local management of Medical Affairs data generation activities (including but not limit to company sponsor studies that use secondary data, post-hoc analysis, systematic/scoping review, meta-analysis, etc.) in country. 
• The project manager is responsible for coordinating and leading the study team to deliver quality data and trial documents/records that are compliant with assigned concept, codes of Standard Operating Procedures (SOPs) and regulatory requirements.

PRINCIPAL RESPONSIBILITIES may include but no limited to:

• Responsible for country do-ability (if applicable) and site feasibility assessment in conjunction with MAF TA. Implements any local criteria for site selection. Instruct teams on appropriate follow-up of site feasibility report. Recommends suitable sites for selection to participate in trial.
• Responsible for vendor services negotiation and support vendor selection.

• Contributes input to the Trial Plan, CRO and/or Vendor Management Plan, Safety Monitoring Plan, Filing and Archiving Plan at a country level.

• Reviews the draft protocol and oversees documentation needed for data collection and analysis.

• Leads and coordinates study team (including Medical Advisor, RWE scientist, biostatistician, PV, etc.) activities in compliance with Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations.

• Leads local project planning activities to meet study targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment and/or data collection planning, contingency and risk management, and budget forecasting

• Lead negotiation of site/vendor contracts and budgets. Forecasts and manages trial budget to ensure accurate finance reporting and trial delivered –within budget. Adheres to finance reporting deliverables and timelines.

• Leads and coordinates study team meetings (as well as external vendor meetings) and provides or facilitates relevant training when needed (i.e. implementation of study amendment-and changes in study related processes)

• Maintains and updates trial management systems.  Uses study tools and management reports available to analyze trial progress.

• Acts as local contact for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders.
• Other tasks that are assigned by manager

JOB SPECIFIC COMPETENCIES/SKILLS REQUIRED:

• Major in life sciences or relevant
• Minimum of 2+ years of clinical research experience with independent field monitoring experience a must, experience in post authorization studies, RWE, clinical registries a plus
• MNC or CRO industry experience is preferred
• Strong knowledge of GCP, specifically as it applies to investigative site conduct of clinical trials, is required
• Ability to successfully balance multiple priorities and adapt quickly to changing priorities
• Ability to problem-solve is required
• Effective communication via written, verbal and listening skills, with ability to effectively deliver training and educational presentations
• Proficiency using MS Word, Excel and PowerPoint is required
• Fluent English in writing, listening and speaking is required
• Domestic and international travels are required.

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