Clinical Project Manager

Mechelen / 2016053
Contact

Biocartis NV / Email: HR@biocartis.com

Function Type
Full-time
Experience Required

At least 5 years of industrial experience in a similar position is required

Proven successful experience in management of international projects

Sound experience in IVD diagnostics (clinical) development

Strong practical knowledge of compliance and European regulatory environments (FDA is an asset)

Knowledge of molecular diagnostics and the IVD marketplace preferred

Scientific and technology background in molecular diagnostics

Proven experience with  V&V studies for IVDs, clinical study monitoring & auditing

Proven experience with KOL and CRO management

Education

Master's degree in scientific field is required

Functional Area
Clinical Affairs
Travel Percentage
50

Purpose of the position:

The Clinical Project Manager is leading and coordinating the execution of clinical performance evaluation studies at both local and international sites, as part of product development projects. The Clinical Project Manager also provides leadership, guidance and advice regarding clinical operations strategies in line with IVD regulations and overall business objectives.

The Clinical Project Manager is a member of Menu Development team.

 

Tasks/outcome domains:

  • Prepares the clinical performance evaluation strategy in line with product, business and regulatory needs
  • Collaborates with biostatistics to define the clinical study design
  • Develops study related documents and provides overall direction for the clinical sites to establish protocol development
  • Plans and  coordinates execution and interpretation of clinical performance evaluation studies including :
    • clinical site selection, EC/IRB approval, study visits, training of on-site personnel, study close-out visits and trial monitoring with on-site audits of clinical data for accuracy and completeness
    • Writes the clinical report and presents if appropriate.
    • Negotiates all aspects of clinical study agreements and ensures appropriate execution for compliance and performance;
  • Is part of project teams and is responsible for planning and timely delivery of all operational aspects of clinical performance evaluation studies
  • Provides leadership, guidance and support across multiple projects to ensure on-time delivery of clinical development deliverables
  • Serves as Clinical Development representative in design reviews or strategic meetings
  • Mentors and transfers clinical development related knowledge across project teams
  • Establishes best-practices and efficiency improvements, and optimizes clinical study documentation and processes according to overall IVD standards.

 

Profile & Competencies:

Master's degree in scientific field is required

At least 5 years of industrial experience in a similar position is required

Proven successful experience in management of international projects

Sound experience in IVD diagnostics (clinical) development

Strong practical knowledge of compliance and European regulatory environments (FDA is an asset)

Knowledge of molecular diagnostics and the IVD marketplace preferred

Scientific and technology background in molecular diagnostics

Proven experience with  V&V studies for IVDs, clinical study monitoring & auditing

Proven experience with KOL and CRO management

Strong communication and listening skills

Proactive attitude

Self-starter and solution-oriented approach

Excellent interpersonal and team working skills

Excellent technical writing and good documentation skills

Well-developed organization, planning and prioritizing skills

Able to work under pressure and have a flexible approach

Diplomatic and able to maintain secrecy concerning strictly confidential information

Quality minded with attention to detail

Willing to travel frequently - internationally

Participate in the development of others by providing feedback and mentorship.

 

Our offering

We offer you an exciting job in a fast growing international and innovative environment where you can work with top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team. You will have freedom to shape your work and shape your job where you deem it necessary: we value your input. Of course we offer you an appropriate compensation package.

 

Interested?

Please apply by e-mail and send your CV and motivational letter to HR@biocartis.com  using the job ID 2016053 as a reference.  

Deadline for applications is 16 January 2017.

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