Clinical Evaluation Manager

Vor 7 Tagen

Basel, Schweiz BIOTRONIK SE & Co. KG Vollzeit

Clinical Evaluation Manager (M/F/d)

As one of the world´s leading manufacturers of cardio
- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

The Medical Affairs Group is responsible for the design, conduction and evaluation of international first-in-man, regulatory submission and post-marketing trials.

**Your Responsibilities**
- Develop, revise and review clinical strategies/ clinical evaluation plans, clinical evaluation reports, PMCF plans and reports, summaries of safety and clinical performance and clinical investigator brochures. The documents are submitted to regulatory authorities and notified bodies
- Manage the quality, accuracy, and timely production of reports/ plans
- Support risk management activities like development and maintenance of product risk analyses and benefit-risk assessments
- Act as a core team member for product development projects
- Interfaces with risk management, R&D, regulatory affairs, study managers, biostatisticians and marketing

**Your Profile**
- MD or PhD ideally in the field of Cardiovascular Science
- 2-5 years of experience in medical writing preferably in a similar industry including clinical study reports and protocols, as well as a proven track record of publications in peer reviewed journals as the main author
- Excellent presentation and moderation skills, including technical editing and QC skills
- Good understanding of statistics, together with the ability to interpret complex clinical data
- Team oriented, accurate and self-dependent personality with an analytical working style
- Knowledge of MEDDEV 2.7/1 rev. 4 and MDR
- Experience with ISO 14971 and FMEAs, as well as knowledge in Risk Management is a plus
- Excellent command of spoken and written English and German

Are you interested?

Location: Bülach | Working hours: Full-time | Type of contract: Unlimited

Job ID: 50629

  • Clinical Program Manager

    vor 2 Wochen

    Basel, Schweiz Coopers Group AG Vollzeit

    Clinical Program Manager **Tasks & Responsibilities** - Set up, maintain and review PMCF plans and reports for medical devices - Coordinate the collection of PMCF data and conduct follow-up investigations in case of findings - Provide input for related documents such as CEP, CER, SSCP, PMS plan, PMS report/ PSUR - Sets up and oversee the PMCF program for...

  • Clinical Program Manager

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz Actalent Vollzeit CHF 100'000 - CHF 120'000 pro Jahr

    Our client, a key player within the Life Sciences industry, is looking for a Global Clinical Program Manager with extensive knowledge and experience in project management, clinical program management within the context of clinical studies, and significant experience in Good Clinical Practice (GCP).Responsibilities:Responsible for partnering with key...

  • Clinical Data Manager

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Planet Pharma Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

    Planet Pharma is seeking a Clinical Data Manager to work for a company in Switzerland.As a Data Manager, you will play a key role in ensuring the integrity and quality of clinical data. Your responsibilities will include:Ensuring all Data Management activities adhere to internal standards and regulatory requirementsSupporting the development and testing of...

  • Clinical Study Manager

    vor 1 Woche

    Basel, Schweiz Hobson Prior Vollzeit

    Hobson Prior are currently looking for a Clinical Study Manager to join a fantastic biotech business on a contract basis located in Basel. Our client is focused on offering available advanced medicines for people who suffer from rare illnesses. Please note that to be considered for this role you must have the right to work in this location. **Key...

  • Clinical Operations Manager

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Actalent Vollzeit

    Clinical Operations Manager – Pharmaceutical TrialsLocation:Basel area, CHEmployment Type:12 months contract, initiallyIndustry:Clinical Research / PharmaceuticalsAbout the RoleOur client is seeking an experiencedClinical Operations Managerto lead and supervise all operational trial-related activities and the operations team assigned to global clinical...

  • Manager Clinical Supply

    vor 4 Wochen

    Basel, Schweiz gloor&lang AG Vollzeit

    Permanent | Full-time | Switzerland (Basel Area) We are supporting a growing, innovation-driven biopharmaceutical company in hiring an experienced Clinical Drug Supply Manager to strengthen its Clinical Supply Operations team. As the company expands its global clinical development programs, this newly created position will play a key role in ensuring the...

  • Manager Clinical Supply

    vor 2 Wochen

    basel, Schweiz gloor&lang AG Vollzeit

    Permanent | Full-time | Switzerland (Basel Area) We are supporting a growing, innovation-driven biopharmaceutical company in hiring an experienced Clinical Drug Supply Manager to strengthen its Clinical Supply Operations team. As the company expands its global clinical development programs, this newly created position will play a key role in ensuring the...

  • Manager Clinical Supply

    Vor 3 Tagen

    Basel, Schweiz gloor&lang AG Vollzeit

    Permanent | Full-time | Switzerland (Basel Area) We are supporting a growing, innovation-driven biopharmaceutical company in hiring an experienced Clinical Drug Supply Manager to strengthen its Clinical Supply Operations team. As the company expands its global clinical development programs, this newly created position will play a key role in ensuring the...

  • Director, Clinical Trial Management

    vor 1 Tag

    Basel, Schweiz Proclinical Vollzeit

    Proclinical are searching for a highly experienced and innovative Director of Clinical Trial Management to join our client, a clinical-stage biotech organisation specialised in radio-immune therapies. Report into: Head of Clinical Operations **Responsibilities**: - Develop and implement clinical trial processes and procedures to ensure compliance with...

  • Clinical Study Manager

    Vor 7 Tagen

    Basel, Schweiz Hobson Prior Vollzeit

    Hobson Prior are looking for a Clinical Study Manager to join a brilliant biopharmaceutical organisation on a permanent basis located in Basel. Our client is focused on helping ground-breaking foreign businesses to be recognised in Switzerland. Please note that to be considered for this role you must have the right to work in this location. **Key...