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

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.