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

在 Johnson & Johnson，我们相信健康就是一切。 我们在医疗创新方面的实力使我们能够建立一个能够预防，治疗和治愈复杂疾病的世界,在这个世界中,治疗更智能，侵入性更低,并且解决方案是个性化的。 凭借我们在创新医学和医疗技术方面的专业知识,我们处于独特的地位,能够在当今的全套医疗保健解决方案中进行创新,以实现未来的突破,并对人类的健康产生深远的影响。 如需了解更多信息，请访问jnj.com

在我们的信条指引下，强生公司对全球范围内与我们共事的员工负有责任。我们提供一个包容的工作环境，在这里每个人都被视为独立的个体。在强生，我们尊重员工的多样性和尊严，并认可他们的价值。

工作职能：Non-Standard

作业子功能：Non-Employee

职位类别：Non-Standard

所有职位发布位置：Beijing, China

职位描述：

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.

Required Skills:

Preferred Skills: