Clinical Study Lead

Send your application in English to:
[email protected]
Mark the application:
“Clinical Study Lead”
We conduct interviews as we receive
applications
Clinical Study Lead
Join us in improving surgical outcomes through generation of
clinical evidence for all of BK Medical solutions.
Clinical Study Lead for Clinical Affairs
Leading and driving medical device Clinical Investigations
BK Medical is committed to designing ultrasound systems that help surgeons image,
Do you also love clinical data? Would you like to lead all clinical study activities for super exciting
guide, intervene, and navigate inside the human body. Surgeons are our customers,
active surgical imaging systems to improve surgical outcomes?
and they range from HPB surgeons, neurosurgeons, and robotic assisted surgeons
to urologists, colorectal surgeons, and more.
You will be working closely with Clinical Evidence Leads and Product Strategy Directors for the
different BK Medical clinical application areas to identify what clinical data is needed to support
the products from a clinical, commercial and regulatory perspective.
Our key values:
As the function is brand new you will be instrumental in building the clinical study area in
collaboration with the Director Clinical Affairs and other relevant stakeholder across the business.
▪ We work with great passion and always strive to get to the next level
Our ambitions are high and we ensure great team spirit, a scientific but fun environment and
value cross functional collaboration to make us a success.
▪ We do what we say and say what we do
You:
▪ We are open, direct and look out for each other
• Drive the availability of clinical data for BK Medical’s medical devices to support the
business and be responsible for delivering timely and appropriate clinical evidence for ▪ We are aware of the basic needs and requirements of our customers. At the
both new products as well as legacy products.
same time, we see opportunities instead of limitations
• Be responsible for design of all clinical investigations including driving protocol
development and discussing our clinical plans with regulatory authorities and investigators
• Develop, maintain, and expand collaborations with outside clinical investigators, At our European headquarters in Herlev the work atmosphere is casual, and our
researchers and thought leaders to facilitate the optimum performance of clinical
organizational structure is flat. We have a good staff canteen focusing on health and
development programs.
variety, we have private health insurance and pension plans as well as social joint
• Manage the process of screening, qualifying, selecting, and contracting with investigators, events and several staff clubs.
sites and vendors required for conduct of clinical investigations and other clinical study
activities in collaboration with Clinical Study Specialists and develop timelines and
budgets.
• Obtain necessary clinical study approvals from IRBs/ECs, regulatory bodies, and
Competent Authorities as relevant and ensure studies are on track for site initiation,
patient recruitment and enrolment, and take corrective actions where necessary to
address issues.
• Develop SOPs and work instructions to assure internal files and clinical study files
(patient; site; country) conform to Good Clinical Practice regulations and standards.
• Help in providing oversight of investigator-sponsored studies.
Clinical Affairs
You will be joining a Clinical Affairs function under development.
Our ambitions are high, and we ensure great team spirit, a scientific
but fun environment and value cross functional collaboration to
make us a success.
We are responsible for generation of relevant clinical data and to
elevate clinical evidence of safety and performance to ensure
sufficient, timely and compliant clinical documentation to support
and drive commercialization of BK Medical’s product range.
As the function is brand new you will be instrumental in building the
clinical study area in collaboration with the Director Clinical Affairs
and other relevant stakeholder across the business.
You are welcome to contact Helene Gustafsson, Director Clinical
Affaris, by phone +45 2547 8905 or send an e-mail to
[email protected].
BK Products Guides Procedures for the Surgeon
Urologist Neurosurgeon HPB Surgeon
Colorectal Surgeon Robotic Surgeon Adjacent Market Users
BK Medical
“By working within these
Global Organization
specialties, I realized that I could
BK Medical is an international company with sales offices all over the world, and European headquarters in
provide or improve the health care
Herlev, Copenhagen.
system that way.”
At BK Medical, we support employees in developing their skills and expertise. We have a professional and
- Rikke von Barm, Specification Engineer
informal organization with flexible working conditions and a flat organizational structure. We are effective
and can execute our ideas into strong products – these ingredients make BK Medical an exciting and
development-oriented workplace.
We look forward to welcoming you to a team that makes a difference– a difference to quality of life.
Intraoperative Ultrasound
BK Medical is committed to designing ultrasound systems that help surgeons image, guide, intervene, and
navigate inside the human body. Surgeons are our customers, and they range from HPB surgeons,
neurosurgeons, and robotic-assisted surgeons to urologists, colorectal surgeons, and more.
Our mission at BK is to enable real-time intraoperative guidance during surgical procedures, giving
surgeons the information needed to immediately make critical decisions. Our products are designed and
customized for surgical procedures, to help surgeons save time and get results.
As market leaders, we work closely with experts and universities to provide the best solutions to clinical
challenges.
“I chose to pursue a career in the
Research and Development
medtech industry because I want
BK Medical has development departments in Denmark and the US. The largest development team is based
to work at a place where both the
in Denmark. We develop software, hardware, mechanics, signal processing, and advanced algorithms.
company and the colleges always
When it comes to research, we have collaborated with the Technical University of Denmark (DTU) for more
than 20 years. Together, we have completed 2 high technology projects for advanced ultrasound imaging.
strives for achieving better.”
We are currently part of a large-scale project with DTU, Danish hospital Rigshospitalet, and the University
- Rasmus H. Rossen,
of Copenhagen concerning extreme high-resolution ultrasound.
Senior Mechanical Engineer
Apply for the position:
[email protected]
Mark the application:
“Clinical Study Lead”
We conduct interviews as we receive applications