[Janssen] Clinical Trial Manager - APAC

Job Title: Clinical Trial Manager 

Business: Janssen

Location: Beijing/Zhengdu China, Selangor Malaysia, Taipei Taiwan, Warsaw Poland, High Wycombe United Kingdom, Beerse Belgium, Leiden/Breda The Netherlands

Function: Pharmaceutical 

 

 

Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.

 

We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.

 

We are recruiting for a number of Clinical Trial Managers based in China, Malaysia, Taiwan, Poland, United Kingdom, Belgium and The Netherlands. The CTM will Ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones as leader of the Study Management Team (SMT). This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set up activities as assigned by the GTL.                                                                                                                    

Support GTL in leading related CRO country & site activities.

     

Duties/Responsibilities

• Study Management Team Leader

• Leads the SMT, drives issue resolutions, and provides updates to all Trial Team members on the deliverable status. 

• Ensures required reports are generated and available for real time tracking of trial status. 

• Manage timely and accurate documentation, communication of study progress and issue escalation.

• Site selection, enrollment, monitor study progress

• Contribute to data collection to support the site selection process

• Establish enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical trial level.  Ensures the availability of robust recruitment/contingency plans are in place for each region          

• Ensures timely and accurate documentation and communication of study progress and issue escalation.  

• Financial planning and tracking

• Set-up country budgets and monitor actuals vs forecast for Out of Pocket Expenses, and review assigned vendor invoices/spend.                        

• Supports team by monitoring budgets and expenditures as expected by planned trial budget.  Ensures availability of required reports to support real time tracking of trial status according to trial plan.

• Document development

• Creates and updates study-specific documents such as Monitoring Guidelines, Informed Consent Form, Investigational Medicinal product (IMP) related documentation, Blinding Plan, country and site feasibility related documents. Provide input into cross functional documents such as Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan.

• Training and Investigator Meeting

• Ensures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed. 

• Responsible for the set-up and coordination of Investigator Meetings. 

• Cross functional Study Management

• Act as the primary contact person for the local teams within GCDO. Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit. 

• Demonstrates deep knowledge of protocol and procedures and adequate therapeutic area knowledge.

• Continuous Quality Focus

• Ensure compliance with global Health Authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal audits.

• Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness. 

• Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools.

• Data Cleaning

• Coordinate data cleaning with some supervision towards a timely and successful database lock

• Participate in Global Clinical Development Initiatives as assigned. Can act as a Subject Matter Expert.

• Travel up to 20%

• At least 4-6 years of experience in clinical trail management in pharma or/and in CRO;
• Required Minimum Education: BS degree or equivalent required, preferably in Life Sciences. Experience in the Pharmaceutical industry or CRO. 

• English speaking and
• Mandarin speaking
• Previous clinical trial management experience in Pharma and/or CRO.
• Strong project management skills
• Proven track record in successfully managing various aspects of trials from start-up to database lock
• Previous experience in coordinating global or regional teams
• Proven ability to foster team productivity and cohesiveness.
• Demonstrated experience in presenting to stakeholders
• Ability to competently plan and oversee country and select vendor budgeting process.

• What we’re about: 

• We are passionate about our work, and play vital roles across a range of professional disci-plines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each

• Committed to caring

• Responsible to our communities

• Ready to apply our knowledge and know-how

• Unique in our background and experiences

• The drivers of our own success

• Passionate about doing what’s right

• Make a unique mark in your career

• If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com

  

We respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection