The Clinical team in Denmark is looking for a Clinical Scientist, preferably office-based. The team consists of 26 office- and field-based, dedicated and experienced colleagues, who are working with global clinical activities, primarily regarding medical devices - in an international, dynamic environment.
As a Clinical Scientist you will be a part of the global clinical function and will be responsible for providing scientific expertise in relation to the development of Clinical Studies. In addition, you will coordinate cross-functional teams in the development of a clinical strategy and oversight for the clinical study/program within the area of treatment/technology or disease you are assigned to.
Your main responsibilities as a Clinical Scientist will be to:
- Work with cross-functional teams (Engineering, Regulatory, Business Divisions, etc.) to evaluate new clinical projects and study strategy
- Provide technical and scientific support/guidance for a specific project or area of treatment/technology or disease
- Develop clinical study designs and facilitate the transition of the project to clinical project management team
- Develop and maintain relationships with physician experts (such as National Principal Investigators, Steering Committee Members) to meet company objectives for the project
- Review and provide input to clinical study-related documents, plans and training materials
- Provide support to and review materials for Investigator Meetings and Site Initiation Meetings
- Lead efforts for the analysis, interpretation, presentation and reporting of clinical and imaging data to relevant stakeholders (project teams, executive management, physicians)
- Collaborate with the Clinical Project Manager
- Coordinate the presentation of information to DSMB, in accordance with the DSMB Charter, including, but not limited to, data summaries and presentations, study notifications, patient summaries, and attendance at meetings when necessary
- Coordinate plan for receipt and review of imaging in relevant studies. This includes coordination of efforts in the selection, training and management of core laboratory for the independent review of imaging
- Work with relevant stakeholders to develop and execute publication and presentation plan for the study
- Review study data and milestones, and coordinate study strategy with relevant stakeholders
- Maintain effective communication with cross-functional teams and stakeholders
As a Clinical Scientist, you are expected to have the following qualifications:
- Advanced degree in Life Sciences or Engineering required, PhD or MD preferred
- Extensive experience in the conduct and management of clinical studies
- Proven ability to exercise sound judgment in independent decision making
- Working knowledge of the regulations governing clinical studies with human subjects, and have extensive prior experience in clinical study operations and management
- Experience in writing study protocols and other technical documents
- Excellent communication skills – both verbal and written – in English and Danish
- Willingness and ability to travel 25-50% of the time
It is obvious that you work independently within your own areas of responsibility. More importantly, we expect you to be an excellent team player with a positive and committed approach.
Cook Medical’s company culture is based on a set of strong common values. Responsible, competent, and professional employees are our most important resource.
We have a flat organizational structure and focus on open dialogue. Qualities such as determination, loyalty, and humour are highly appreciated. The staff of Cook Medical helps uphold the company’s philosophy of developing innovative medical solutions to raise the quality of patient treatment worldwide
- we make a difference every day.
Cook Medical offers a well-organized internal training course which is taken by all new staff to enable them to quickly gain thorough knowledge of the company.
In addition to a salary package with pension, we offer flex time, a bonus system, health insurance, and free use of the company’s own gym.
Contact Maja Skytte, Director of Clinical Affairs, EMEA by phone: +45 23 28 23 38 or e-mail: firstname.lastname@example.org.
Applications must be submitted no later than April 2, 2019.