Are you the proactive and competent colleague who approaches projects with a team players’ spirit and positive drive?
Be a part of Contura International’s success and growth, as Clinical Research Manager.
In this exciting new role, the Clinical Research Manager, has the responsibility for Managing all aspects of the clinical trial activities, within medical device regulations (MDR and PMA), from Phase II to IV in collaboration with CROs, and freelance CRAs in UK and EU.
You will collaborate with internal stakeholders Marketing, Regulatory Affairs, Quality Assurance, R&D, as well as with external stakeholders: Key Opinion Leaders, Investigators and study coordinators.
Are you the proactive and competent colleague who approaches projects with a team players’ spirit and positive drive? And are you at the same time, good at working independently and are able to plan, structure and drive your own tasks? And do you like to work for a company who besides the business also love to have fun and celebrate every step ahead. This might be the right job 🙂
- University degree in medicine, sciences or related
- More than 5 years’ experience in conducting clinical trials, preferably with medical devices. Experience in pharma and/or Clinical Research Organization (CRO) is also acceptable
- Experience with managing clinical research projects
- Good understanding of clinical research strategic and operational aspects
- Understand the basic medical terminology and science associated with relevant therapeutic areas, e.g., rheumatology/orthopaedic surgery
- Regulatory knowledge is preferable
- Possess the understanding of Good Clinical Practice regulations, ICH guidelines
- Excellent knowledge of MS Office
- Good verbal and written communication skills
- Fluency in Danish and English
- Well-organized, flexible, pro-active
- Ability to work independently as well as in a team matrix organization and multiple projects
- Ability to maintain a good overview when working on multiple tasks and meet agreed deadlines
- Open minded and enjoy teamwork
- Able to work in a fast-paced environment with changing priorities
- Ability and willingness to travel about 20 days a year
Individual responsibilities & authorities
Manage all aspects of the clinical trials activities, including:
- Ensure full compliance with the protocol and ISO 14155 GCP
- Ensure that safety concerns and/or adverse events are identified and addressed as applicable identified and reported to competent authorities, if needed
- Ensure trial milestones, budgets and timelines are in line with corporate and business objectives
- Act as primary liaison with study site personnel
- Provide guidance at the site and project level towards audit/inspection readiness standards and support preparation for audit and required follow-up actions
- Development of clinical documentation, e.g., clinical protocols, reports etc.
- Develop and maintain SOPs/Work Instructions/Forms for Clinical Affairs
- Ensure high quality performance through adherence with Contura QMS and all relevant international regulatory requirements
- Support Contura interactions with regulatory authorities concerning clinical documentation, review and/or approve clinical documents for regulatory submissions (FDA, Competent authorities, Notified bodies, IRBs, ECs, etc.)
- Monitor and understand results of clinical investigations in preparation for new medical device applications and maintain post market clinical data requirements
- Prepare for and participate in internal/external audits
- Participate in other tasks as agreed
- Report to Medical Affairs Director
- Cooperation with other departments and colleagues
- Cooperation with external collaborators
- Cooperate with QA and RA Departments in handling communication with competent Authorities, Notified Body, FDA and other relevant authorities in connection with Contura’s product registration
- Represent, where appropriate, Clinical Affairs in meetings with regulatory agencies (FDA, Notified Bodies, IRBs, ECs, etc.); and
- Cooperate with relevant stake holders in aiding investigator sponsored clinical research and publications.
For additional information please contact Beirholm Search, at www.Beirholmsearch.dk or Hanne Beirholm at tel. 29440080.
Contura is a Copenhagen based medical technology company that develops and manufactures innovative medical products in the fields of orthopedics, women´s health, soft tissue augmentation and animal health using its unique, patented hydrogel technology.
The manufacturing facility, which is approved in US, Europe, Canada, Australia, etc., has been uniquely designed and fulfils global regulatory requirements to deliver Contura´s entire range of hydrogel products.
For more information about the company, please visit www. Contura.com, www.bulkamid.com and www.arthrosamid.com.