PROJECT COMPLIANCE MANAGER

Job Category: Clinical Operations
Contract type: Full Time Part Time
Job Location: Zeist NL

Job description

Varied work – international setting/ projects

Are you a (Senior/Lead) CRA or Clinical Team Lead and do you have – by nature- a passion for streamlining and developing processes in (international) clinical trials?  Then maybe this will be the next step in your career. Julius Clinical is looking for an energetic Project Compliance Manager with a go-getter mind set.

Working in project compliance means every day is different. One day you are developing processes, the other day you are performing Project Compliance Checks. Whether you are creating a monitoring manual, answering questions from the project teams or providing training to the CRA’s; one thing is for sure, you are constantly interacting with people in- and outside our organization. You will deal with different stakeholders throughout the organization and you will answer questions from every corner of our organization. You will work at the same time on different (international) clinical trials, in different therapeutic areas and in different phases. Each clinical trial requires its own approach, which makes the job very interesting and challenging.

As PCM you will ensure compliance with the Julius Clinical and regulatory quality requirements and standards by providing compliance management of clinical trial processes, tools, reports and systems across assigned clinical trials. The job asks you to perform in a calm and organised/structured way during demanding, challenging circumstances.

Tasks and responsibilities

Depending of your working experience and skills, you will be more or less supportive in the following tasks/ responsibilities. You will:

  • Develop project specific clinical trial processes for assigned clinical trials as defined in the scope of work (e.g. monitoring manual, training plan, Project File Indexes  and templates, etc.);
  • Ensure implementation of the clinical trial processes with all parties (including sponsor) involved in the clinical trial by means of training the project team;
  • Participate in developing, maintaining and improving the clinical trial processes as required;
  • Act as the primary contact for escalation of any issues with procedures by all involved parties, including the sponsor;
  • Review project specific plans and proposed clinical trial processes for compliance and practical issues and contributes to risk analysis;
  • Initiate updates of written clinical trial processes;
  • Develop, plan and execute project specific compliance checks on clinical trial processes in accordance with the project specific compliance management plan;

Analyze the findings of the project specific compliance checks for relevance across the assigned clinical trial.

Job requirements

  • Higher level of education in a (bio)medical field;
  • Basic knowledge of legislation and regulations, clinical processes, industry practices and ICH-GCP and guidelines;
  • A minimum of 3 years of experience as a Clinical Research Associate, Clinical Team Lead or Project Manager;
  • Experience with working (on site) in international clinical trials is preferable;
  • Experience in and passion for training/instruction and harmonising clinical project processes is preferable;
  • Adequate command of English (in speech and writing) and preferably also in Dutch;
  • Creative /out of the box approach; multitasking, flexible, stress resistant and good overview skills.

We offer

Our company culture can best be described as dynamic, open, co-operative, motivational, collegial, and inspirational. We set clear goals, work hard to attain them, and celebrate our successes.

We offer training and support to become a specialist in project compliance and to develop your personal and professional skills. You will be trained on the job from the start by for example assigning you a buddy and an onboarding program.

We are located in a beautiful monumental building, near Slot Zeist, close to public transport. Our employees have the flexibility to combine working from home and working at office.

How to apply

Interested in this position? Apply below or send your CV and motivation to vacancies@juliusclinical.com

If you have any further questions, please call Ellen Hunink (HR Business Partner, +31 6 2116 2980), or Madelon Brummelhuis (Manager Project Compliance, +31 6 4626 1228).

 

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