Clinical Project Manager - Global Medical Affairs at Wellspect AB

Wellspect Healthcare, with headquarters in Gothenburg, Sweden, is a leading global provider of innovative medical devices with a focus on helping people suffering from urinary retention or chronic constipation. Every day, more than 1 100 employees are dedicated to make a difference for those who need our products and services. Many of the people we serve have a spinal cord injury, enlarged prostate, spina bifida or multiple sclerosis. We are one of the world’s leading manufacturers of intermittent urinary catheters, with LoFric® as our most known brand. As a help to those with chronic or severe constipation we have developed what likely is the world’s most advanced irrigation system, the Navina Systems™, combining a high degree of user convenience, clinical effectiveness and connectivity into one really smart system. Wellspect HealthCare has a presence in more than 30 countries, and is a part of Dentsply Sirona, the worlds´ largest manufacturer of professional dental products and technologies with global headquarters in York, Pennsylvania, and international headquarters in Salzburg, Austria. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.

Please visit www.wellspect.com and www.dentsplysirona.com for more information.

Would you like to be part of an agile team of Clinical Research experts developing Clinical Evidence to support regulatory and commercial needs?

About the position

As Clinical Project Manager at Wellspect you are driving prioritized clinical projects from protocol development to finalization of the investigation report. Adherence to quality, time lines and budget are natural parts of your way of working. Thus, the role requires a scientific mindset, ability to get things done, and strong integrity.

Your key accountabilities are:

• Overall responsible for clinical project execution including protocol development, site selection, submissions budgeting, data management, quality control, data cleaning and report writing
• Project compliance with applicable regulatory requirements
• Capability to drive a variety of study types (e.g. size, design, geographies, indications, phases)
• To manage multidisciplinary study teams including external vendors
• To represent the function in cross functional forums, such as product development projects or during audits

Who you are

We believe that you are a positive, solution-oriented, prestige less and hands-on person who loves to deliver on, or above, expectations. You are a team player but also comfortable with working independently, always with an appropriate sense of urgency. You are comfortable with all parts of clinical project management. You challenge and explore status quo with a clear ambition to add value, ultimately improving the overall efficiency and way of working.

We believe you have:

• Relevant medical/scientific degree
• Minimum 5 years of documented experience, preferably within Medical Device, as CPM, CRM or similar
• Good knowledge in applicable regulations and guidelines governing clinical research eg. ISO14155/GCP
• General understanding of medical device development and product life cycle requirements
• Statistical knowledge is an advantage
• Vendor management experience is a merit
• Proficient in English (verbal and writing)

Good to know

The position includes some travelling. Preferably we want to fill this position as soon as possible, but finding the right individual is key to us.

Your application

In this recruitment we are cooperating with Your Talent AB. Do not hesitate contacting Recruitment Consultants Martina Träen (+46 722888220) or Johan Sjöberg (+46 761709851) if you have any questions. We are interviewing candidates continuously, so in order to enhance your chances, we recommend that you send us your application as soon as possible, however at latest January 30th 2020.