Clinical Study Manager

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Medicontur Orvostechnikai Kft.
Munkavégzés helye

1113 Budapest, Daróczi út
Egyéb juttatások
- Cafeteria
- Nyelvtanulás támogatása
- Munkába járás támogatás
- Sport támogatás
- Élet- és balesetbiztosítás
- Beiskolázási támogatás
Munka típusa
- Teljes munkaidő
- Home office
- Alkalmazotti jogviszony
- Általános munkarend
Biztosított eszközök
- Laptop
- Mobiltelefon
Elvárások
- Angol felsőfok
- 1-3 év tapasztalat
- Egyetem

Cafeteria Nyelvtanulás támogatása Munkába járás támogatás Sport támogatás Élet- és balesetbiztosítás Beiskolázási támogatás

Teljes munkaidő Home office Alkalmazotti jogviszony Általános munkarend

Laptop Mobiltelefon

Angol felsőfok 1-3 év tapasztalat Egyetem

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Discover a career with Medicontur, a thriving European company boasting a rich 35-year history and over 400 dedicated employees.

With a remarkable record of producing and selling over 6 million intraocular implants, Medicontur stands at the forefront of innovation in the ophthalmic medical devices sector in the treatment of cataract and other ocular diseases.

We take pride in our global recognition as a premium IOL company, all while maintaining a steadfast commitment to putting patients first.
Medicontur isn't just a company; it's a commitment to transforming lives through groundbreaking technology and unwavering dedication to improving the lives of individuals worldwide

To complete the changed regulatory requirements, Medicontur is now looking for an ambitious

Clinical Study Manager

Responsible for generating clinical data for Medicontur's medical devices, managing the planning, documentation, initiation and execution of clinical investigations, and
Scientific and regulatory content writing

Tasks:

Planning and writing of clinical investigation plans, consent form, CRF, other study documents;
Preparing and/or submitting the request for approval to the ethics committee/competent authority;
Direct involvement in the implementation of clinical investigations, site initiation, monitoring, study close-out;
Train/Educate study staff;
Monitor clinical investigation through on-site monitoring visits and source data verification/review;
Ensure that the Investigator and study staff adhere to the clinical investigation plan, applicable regulations and GCP requirements;
Maintains constant contact and motivate investigators, site staff and executes Investigator meetings;
Management of TMF and ISF;
Data collection and analysis, clinical investigation report writing;
Writing of scientific publications and professional content;
Developing and updating QMS procedures and document templates describing the clinical investigation activities,
Selection and coordination of service providers: eCRF development, CRO, etc.

Requirements:

Excellent knowledge of GCP and/or ISO 14155 requirements, with experience with their practical application
University (MD, Dr. Pharma, MSc, optometry) degree (preferably a scientific/medical background)
2+ years’ work experience in a similar position, preferably in the medical device sector
Fluent English in written and spoken form, MS Office strong user-level
Professionalism, proactivity, precision, endurance, flexibility and prioritization skills
Ability to work independently, problem solving and communication skills

What we offer:

Your performance will be recognised with a range of benefits in addition to your basic salary:

Cafeteria: gross annual cafeteria allowance of HUF 624.00 (can be used for SZÉP card, pension fund, health fund or Wáberer Medical private health service)
Bonus: annual one-off payment based on performance evaluation
Family support: daycare (gross HUF 300.000 /year), kindergarten (gross HUF 150.000 /year) and school allowance (HUF 30.000 /year)
Travel to work allowance: in the form of a fuel subsidy or 100% travel pass subsidy
Company phone and laptop
Dental discounts for Medicontur employees at our premium dental partner
Vision allowance: you can get a subsidy every 2 years when you buy glasses frames or contact lenses
Free language learning: complimentary English lessons on our premises, at various levels
Life and accident insurance: taken out with Allianz Insurance for all our employees
Referral reward: through our "Refer a friend" referral scheme, successful referrals are rewarded with a referral reward
All You Can Move Sportpass (AYCM) possibility
Home office
Corporate events, team buildings