Clinical Study Manager
Life Technologies Europe B.V. Nederlaenderna Fil / Biomedicinjobb / Uppsala
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LOCATION: Uppsala, Sweden
IMMUNODIAGNOSTICS DIVISION
Thermo Fisher Scientific's ImmunoDiagnostics Division (IDD) develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and follow-up of allergy and autoimmune diseases. With 1,900 employees worldwide, IDD is the global leader in in vitro IgE testing for allergy and the European leader in autoimmunity diagnostics.
HOW WILL I MAKE A DIFFERENCE?
You will be joining the Scientific and Medical Affairs team, who is responsible for developing scientific and clinical evidence for both existing and new in-vitro diagnostic products. We manage and govern pre-and post-marketing research and we provide a synthesis of available knowledge and disseminate this knowledge through publications, education and scientific meetings. Our goal is that the scientific quality of our evidence generation activities will impact clinical and health care providers guidelines and therefore have a positive impact on both healthcare and how patients are managed with the ultimate objective of improving patient outcomes and public health.
WHAT WILL I DO?
Generate and communicate evidence with the aim of improving patient access to IDD's innovative diagnostics, whilst ensuring compliance to all internal and external regulations and guidelines. The CSM will prepare and conduct approval board meetings, oversee contract negotiations, implementation of the study and follow-up on study progress at regular intervals, under the supervision of the Senior Director Scientific and Medical Affairs.
You will interact closely with the medical directors, submitters of applications, product planning and logistics, legal and compliance, with the main responsibilities being to:
• Act as the main point of contact for any incoming applications and communications
• Initiate and managed the approval process
• Prepare, lead and document all approval board meetings
• Initiate contracts and agreements
• Maintain follow-up communication with relevant stakeholders
• Keep metrics on submitted applications
• Educate and train (new) stakeholders on the processes involved
You will also support any audit activities related to clinical validation data submissions and the respective processes involved. In collaboration with Scientific Affairs, you will ensure all generated data can be used for scientific and marketing purposes. You will also have the possibility to participate in the process improvement activities in relation to the areas of responsibilities, and work strategically to help integrate clinical validation activities into the product development process.
HOW WILL I GET THERE?
We are looking for a motivated and proactive individual, who is used to working internationally and has several years of experience from the pharmaceutical, medical device, or diagnostics industry.
The successful candidate should have the following skills and experience:
• Undergraduate degree in a clinical, scientific or related field.
• Documented experience in the IVD industry. Knowledge and experience with applicable regulations and guidelines (e.g. GCP, Sunshine Acts).
• Scientific knowledge in clinical research methods and IDD products is of advantage.
• Demonstrated ability to operate independently, to take initiative, be resourceful, and exercise astute business judgment to drive performance.
• Strong written and verbal communication skills including fluency in English (written and spoken).
• Must have excellent interpersonal, verbal, and written presentation skills.
• Experience in usual software (Word, Excel, Power Point)
• Demonstrates the Thermo Fisher values - Integrity, Intensity, Involvement and Innovation (The Four I's)
WHAT WE CAN OFFER:
• A career in an international company with a global impact
• Development through continuous learning and developing skills and abilities
• Cooperation with colleagues and teams across business functions, divisions and countries
APPLY NOW on our career site:
http://jobs.thermofisher.comIf you have questions about Thermo Fisher Scientific and/or the position - please contact Victoria Johansson (Senior Recruiter Nordics) -
Victoria.johansson@thermofisher.comPubliceringsdatum2021-06-18Så ansöker duSista dag att ansöka är 2021-07-03
Klicka på denna länk för att göra din ansökanAdressLife Technologies Europe B.V. Nederlaenderna Fil
Uppsala
75450 UPPSALA
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Life Technologies Europe B.V. Nederlaenderna Fil (org.nr 516402-5800)
Uppsala (
visa karta)
754 50 UPPSALA
Arbetsplats Phadia AB
Jobbnummer 5819422
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