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Senior Clinical Operation Manager – RSP system, Odense

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Odense

RSP Systems is currently looking for a Senior Clinical Operation Manager to lead a team of four persons. As Senior Clinical Operation Manager you will take the overall responsibility for Clinical Operation at RSP Systems, managing the clinical trials on time, on budget and in compliance.

RSP Systems A/S are developing a non-invasive glucose meter based on Raman spectroscopy. Striving to bring painless glucose monitoring to diabetic patients all over the world. To strengthen their development efforts, we are looking for a new colleague for them, who can handle the everchanging working environment in an emerging MedTech company.

Position
The Senior Clinical Operation Manager will be heading the clinical operation team and conduction of premarket clinical investigations. The main task is to oversee, lead and manage cross-functional team resources including external service providers, such as clinical operations, data management, auditors, and consultants. The most important success criteria are to conduct trials on time, on budget and in compliance.

Position

Your main areas of responsibility and tasks will be:

Your main areas of responsibility and tasks will be:

  • Responsible and accountable for the conduct of clinical trials.
  • Ensure clinical operation team and clinical trial sites are properly trained and in compliance with company and/or CRO SOPs, CFR/EMA regulations, ICH GCP guidance and study protocol.
  • Identify any gaps in company and/or CRO SOPs and develop internal SOPs as needed.
  • Manage and maintain relations with clinical trial sites, including collaborating with Principal Investigators. Perform site initiation visits, as needed.
  • Negotiate study agreements and budgets with sites and external vendors.
  • Assist with the development of presentations, handouts and coordination of Investigator Meetings.
  • Drive site selection and patient recruitment programs that deliver enrolment targets.
  • Responsible for ensuring the trial is “audit ready” at all times.
  • Provides regular updates to management team, concerning status and progress of the trials.
  • Development of clinical operational strategy.
  • Manage maintenance of internal quality system, according to ISO 13485 and ISO 14155.
  • Assist management in development of written material for various stakeholders - Board of directors, Investors etc.


    • Responsible and accountable for the conduct of clinical trials.

    Ensure clinical operation team and clinical trial sites are properly trained and in compliance with company and/or CRO SOPs, CFR/EMA regulations, ICH GCP guidance and study protocol.

    Identify any gaps in company and/or CRO SOPs and develop internal SOPs as needed.

    Manage and maintain relations with clinical trial sites, including collaborating with Principal Investigators. Perform site initiation visits, as needed.

    Negotiate study agreements and budgets with sites and external vendors.

    Assist with the development of presentations, handouts and coordination of Investigator Meetings.

    Drive site selection and patient recruitment programs that deliver enrolment targets.

    Responsible for ensuring the trial is “audit ready” at all times.

    Provides regular updates to management team, concerning status and progress of the trials.

    Development of clinical operational strategy.

    Manage maintenance of internal quality system, according to ISO 13485 and ISO 14155.

    General expectations of competences and experience

  • Experience with approval of clinical trials on an international basis.
  • Project management experience.
  • Understand medical device development process.
  • Worked with MDD and MDR.
  • Experience with data management.
  • Experience with GDPR.
  • Excellent written and oral communication and presentation skills.
  • Experience operating effectively within a matrixed environment.
  • Ability to prioritize tasks and resources, meet deadlines and be flexible to changing priorities.


    • Experience with approval of clinical trials on an international basis.

    Project management experience.

    Understand medical device development process.

    Worked with MDD and MDR.

    Experience with data management.

    Experience with GDPR.

    Excellent written and oral communication and presentation skills.

    Experience operating effectively within a matrixed environment.

    Personal qualifications

    Personal qualifications

  • Strong interpersonal and communication skills.
  • Leadership capabilities and able to create results in a cross-functional role.
  • Highly organized and detailed-oriented.
  • Flexible and work well with deadlines.
  • Ability to priorities tasks.
  • Analytic person.
  • Team player.
  • Full of initiative and has a hands-on mentality.
  • Odense is a natural place for you to work


    • Strong interpersonal and communication skills.

    Leadership capabilities and able to create results in a cross-functional role.

    Highly organized and detailed-oriented.

    Flexible and work well with deadlines.

    Ability to priorities tasks.

    Analytic person.

    Team player.

    Full of initiative and has a hands-on mentality.

    You will be part of a highly dynamic work environment and have the opportunity to work with a wide range of tasks. RSP Systems values highly motivated and purpose-driven team members, providing you with the opportunity to develop professionally and influence your future line of work.

    Application
    The position will be closed as soon as possible, so do not hesitate to send your application. Please always feel welcome to contact us for further details; we look forward to hearing from you.

    Company
    RSP Systems A/S is dedicated to improving the health and quality of life of people worldwide through its unique and patented solution for non-invasive diagnostics. The first targeted application is a product line of non-invasive glucose monitors, which will provide diabetics with a convenient, pain-free alternative to the current invasive solutions, which require finger pricking to extract blood onto an expensive test strip. Self-monitoring of glucose is a key element in efficient diabetes management and constitutes a global market exceeding USD 10 billion annually. Other potential applications include measurement of alcohol and lactate.

    Company

    RSP’s technology is based on a direct optical detection principle, Raman spectroscopy, a mature technology to which RSP has developed and patented improvements enabling the measurement of concentrations of various substances in the interstitial fluid (tissue fluid surrounding the cells of the body) non-invasively through the skin. Proof-of-concept for glucose monitoring in diabetics has been demonstrated through pilot investigations in collaboration with Odense University Hospital in Denmark.

    RSP Systems A/S was founded in 2006 as a spin-out from the Biophotonics Group at the University of Southern Denmark (SDU). Today, the company employs a small organization and leverages its resources by partly outsourcing its development activities to an established network of suppliers and partners in Europe, North America, and Asia.

    For more information, please visit www.rspsystems.com

    Please note that due to GDPR rules we do not accept applications/CV via e-mail.

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    Information og data

    Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".

    Arbejdsstedet er beliggende i Odense

    Jobbet er oprettet på vores service den 6.9.2019, men kan have været deaktiveret og genaktiveret igen.

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    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • Afdelingsleder
    • Odense
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