Global Clinical Project Manager

Are You experienced in Clinical Research? Would you describe yourself as a hands-on type of person with a natural talent for solving issues and pushing for progress? Then we may have the right position for you! Reporting to the Head of Global Medical Affairs, you will be part of an agile team of clinical research experts developing clinical evidence to support commercial needs and regulatory requirements.
As Global Clinical Project Manager at Wellspect you are driving prioritized clinical projects. Adherence to quality, timelines and budget comes natural for you. The role requires a scientific mindset and ability to get things done. To succeed in this role you are dependent on successful collaborations with internal and external stakeholders.
Responsibilities:
Accountability for all parts of clinical project execution, ie from protocol development to report finalization
Compliance with applicable standards, rules and regulations
Ability to drive a variety of project types (e.g. size, design, geographies, indications, phases)
To manage dynamic and multidisciplinary study teams including external vendors
To represent the function in cross functional forums, eg. development projects and during audits


Qualifications / Background
Relevant medical/scientific degree, typically on MSc level
3-5 years of relevant and documented experience, preferably within Medical Device
Good knowledge in applicable regulations and standards governing clinical research eg. ISO 14155/GCP and MDR
Insight in medical device development and life cycle requirements is an advantage
Statistical and data management knowledge is beneficial, as is vendor management experience
Proficient in English (verbal and writing)


We believe that you are a positive, solution-oriented and hands-on type of person with a strong sense of accountability for your work. You enjoy the mix of working in a team as well as independently, always with an appropriate sense of urgency. You challenge and explore status quo with a clear ambition to add value, constantly striving for efficiency improvements.
The position includes some travelling. Preferably we want to fill this position as soon as possible and will assess candidate on a continuous basis, however finding the right individual is our top priority.
We look forward to hearing from You.