Project Compliance Manager

Geplaatst:

Beschrijving

As Project Compliance Manager you will ensure compliance with our client’s 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 organized/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.

DESIRED SKILLS & EXPERIENCE
• 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 harmonizing 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.

Solliciteer op: Project Compliance Manager

CV & Motivatie (max. 3 bestanden: doc, docx, pdf, jpg)
For our customer (CRO) we are looking for an energetic Project Compliance Manager with a go-getter mind set. Open to discuss further? Please contact us!