About usAs LINK Medical continues to grow, we
currently have an open position at our office in Berlin (DE)LINK
Medical is searching for a highly motivated Local Regulatory
Contact Study Start-Up (SSU)/Regulatory Lead (Clinical Studies)/
(Sr) CRA in Germany. As a Local Regulatory Contact SSU /Regulatory
Lead (Clinical Studies), you will work in close collaboration with
members of internal and external project teams, with local and
international projects, and within a range of different therapeutic
areas. This role can also be combined with a CRA role. As a CRA you
may also be outsourced to clients, and the position will involve
frequent travelling related to monitoring visits.TasksPerform local
clinical study application submissions in Germany mainly, but also
in Austria and Switzerland. (This includes both medicinal products
and medical device studies and interventional as well as
non-interventional studies.)Preparation and translation of
submission documents (including ICFs).Stay up to date about local
regulatory requirements for drug/ device development/ clinical
study submissions.Provide guidance (internal and external) on
regulatory requirements.Optional (dependent on previous
experience): Contribute to and coordinate regulatory and EC
clinical study application submissions for multi country trials
(including submissions for Clinical Trials with IMPs via CTIS).If
applicable also work partly as CRA including:Monitor and manage
clinical trials (phases I-IV) in compliance with protocol,
ICH-GCP/ISO 14155, SOPs, and regulations. Serve as main point of
contact with the study site.Perform Source Data Review (SDR),
Source Data Verification (SDV) and review Case Report Forms
(CRFs).Document monitoring visits and submitting reports on
time.Handle and distribute study supplies and products, when
applicable.Set up site budgets and agreements.Provide training and
develop study materials.ProfileBachelor's degree or equivalent in a
relevant field.Knowledge of ICH-GCP, ISO14155 and national
regulations.Experience in clinical trials submissions for both
investigational medicinal products and medical device locally and
preferably also internationally incl. UKExperience in monitoring
clinical studies and site management is preferable, but not a
requirement.Fluent in the local language and English.Strong writing
and IT skills.We offerLINK Medical offers an exciting and
challenging position in a European CRO that has a strong local
presence. The company focuses on collaboration, sharing of
experience and continuous development of our employees in an
international environment and values as honest and open
communication are essential. You will be given meaningful tasks
requiring efficient collaboration between industry, clinical and
scientific teams, and the authorities. Besides a great working
environment with dedicated and supporting colleagues, we also offer
a competitive compensation, benefit scheme and great development
opportunities for all employees.ContactContact Information:If you
would like to know more or if you have any questions about the
position, please contact:Elin Nilsson, Director Clinical Project
Management+46 760 382437, Elin.Nilsson@linkmedical.eu orTrine
Dyring, Director Clinical Operations,+45 4127 8470,
trine.dyring.jensen@linkmedical.euAll applications are treated
confidentially and will be evaluated when received, so please apply
as soon as possible. Please submit your application in
English.