Project Compliance Manager (min:0.8 fte)

(Senior) CRA/Lead CRA or Project manager and interested in quality and compliance? Our Project Compliance Managers job can be the next step in your career!

PURPOSE OF THE FUNCTION

Working in Compliance means every day is different. One day you are developing processes, the next you are creating a tool or a training-program for CRAs. Whether you are creating a monitoring manual, organising an Investigators meeting, answering questions about last week's training program or traveling to a foreign country to coach and train CRAs, one thing is for sure: you are constantly interacting with people in- and outside our organisation.

Our Project Compliance team is searching for an enthusiastic and professional new colleague to fill the position of Project Compliance Manager. The current Compliance team consists of two Project Compliance Managers and one Lead PCM. It's a dynamic team of clinical professionals with excellent communication skills. All team members have worked as (senior) CRA and/or Lead CRA and decided to use their experience and expertise in this key role for Julius Clinical trials. The Project Compliance team is part of the Department Clinical Operations and has there for a central place in the  organisation.

As Project Compliance Manager you will ensure compliance with the Julius Clinical quality requirements and standards by providing compliance management of clinical trial processes, tools, reports and systems across assigned trials. The job asks you to perform in a calm and collected way during unexpected circumstances. You will work at our office in Zeist, The Netherlands.

TASKS AND RESPONSIBILITIES

  • Develops standardised clinical trial processes for assigned clinical trials as defined in the Scope of Work (e.g. monitoring manual, communications plan, vendor management plan, etc.)
  • Ensures implementation of the clinical trial processes with all parties involved in the clinical trial
  • Supports involved parties and sponsor in implementing and complying with the clinical trial processes
  • Participates in developing, maintaining and improving the clinical trial processes as required
  • Acts as the primary contact for escalation of any issues by the involved parties and sponsor
  • Remains abreast of new technologies and training methods and amends these, if necessary
  • Reviews proposed clinical trial processes by third parties for compliance and practical issues and contributes to risk analysis
  • Initiates updates of written clinical trial processes (e.g. monitoring manual, communications plan, vendor management plan, etc.)
  • Develops, plans and executes compliance checks on clinical trial processes in accordance with the project specific compliance management plan
  • Analyses the findings of the project specific compliance checks for relevance across the assigned clinical trial
  • Identifies broader trends in order to initiate and implement applicable actions (e.g. training, review of clinical trial processes)
  • Proposes corrective and preventive actions and follow-ups to the General Compliance Manager for approval
  • Initiates approved corrective and preventive actions for all parties involved in the assigned clinical trial

DESIRED SKILLS & EXPERIENCE

  • Higher level of education in a (bio)medical field
  • A minimum of 5 years of experience as a Clinical Research Associate or Project Manager
  • Extensive knowledge of legislation and regulations, clinical processes, industry practices and ICH/GCP regulations
  • Excellent communication, planning and organisational skills
  • Experience in training/instruction and harmonising study process is preferable
  • Adequate command of Dutch and English, in speech and writing

 


Additional Information

Posted
October 24, 2017
Experience
Mid-Senior
Type
Full Time
Functional Area
Clinical Operations

How to apply

Interested in this position? Send your CV and motivation to vacancies@juliusclinical.com

Questions? 

If you have any further questions, please call Chantal van der Meeren, Recruiter, +31 (0)30- 656 9900