Clinical Research Medical Advisor - Munich, Deutschland - Clearstone GmbH

Clearstone GmbH
Clearstone GmbH
Geprüftes Unternehmen
Munich, Deutschland

vor 3 Wochen

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung
VERTRAGSART- Permanent- BESCHÄFTIGUNGSART- Vollzeit- BRANCHE- Pharma & Health- FÄHIGKEITEN- Alle- BERUFSFELD- Clinical Affairs, Gesundheitswesen- GEHALTSARTEN- Jährlich- GEHALT- €100,000.

00 EUR- JOB-ID- 33124
Stellenbeschreibung:


The Clinical Research & Medical Affairs (CRMA) Associate will collaborate closely with global and local partner functions to advance clinical research in Germany and generate evidence for global and locally sponsored studies, Investigator-Initiated Trials (IITs), and other research collaborations in Germany.

The incumbent serves as the central medical contact, internally and externally, responsible for designing, conducting, and evaluating projects to generate clinical data (from Phase I to local Phase IV) for multiple compounds in the portfolio, influencing the overall medical strategy, and addressing medical data gaps required for expedited access.


The CRMA will be part of an innovation team integrated into the Evidence Generation department, advocating for strategies of clinical excellence and evaluating and introducing new opportunities in clinical research.


Your Responsibilities:


  • Leading ongoing clinical studies in Germany (globally and locally) (from NIBR to Phase IV) for multiple compounds in collaboration with all departments involved in clinical research.
  • Close collaboration with the SSO and regulatory authorities to ensure the initiation of clinical studies, recruitment according to the planned timeline, early identification of potential delays, and robust recruitment mitigation plans with Medical Affairs activities.
  • Providing clinical/medical strategic and tactical input into global clinical development plans and protocol designs.
  • Assessing the medical feasibility of implementing a global clinical study protocol based on regional/local medical practices by consulting physicians, local databases (RWE, payer data, feedback from patient associations, etc.), and environmental analysis.
  • Leading the setup and conduct of local Real World Evidence projects (including studies), Investigator-Initiated Studies, and independent clinical/preclinical research projects as well as the implementation of Expanded Access Programs (EAPs), Compassionate Use Programs (CUPs), and Individual Patient Supply Programs (IPSPs).
  • Reviewing and attempting to resolve local medical issues/questions and, where possible, supporting the SSO in recruitment/operational issues arising throughout the study supporting discussion of issues with global teams.
  • Offering solid indication and protocol training for Clinical Research Associates and other functions as needed, as well as for clinical investigators & staff.
  • Ensuring optimal scientific awareness (internally and externally) drug development activities (from NIBR to local Phase IV activities).

What You Bring:


  • Minimum: PhD in natural sciences or related field with a focus on datadriven projects, or Master's degree in Biostatistics/Epidemiology or another biomedical field with relevant experience in pharmaceutical/technology.
  • 5 years of experience in medical or clinical development, with demonstrable experience working directly on projects with a strong focus on data analysis.
  • Preferably good knowledge of drug development and preparation for drug market launch.
  • Expert knowledge of the German healthcare data landscape, including EHR/EMR, registries & consortia, laboratories, distribution, public and private medical data sources.
  • Advanced understanding of data systems and tools.
  • Demonstrated experience in successful work in multidisciplinary and crossfunctional teams.
  • Proactive with the ability to build relationships, collaborate, and influence in a multifunctional matrix organization.
  • Strong interpersonal skills and the ability to successfully interact and influence a wide range of people and build strong positive relationships.
  • Strong and demonstrated successes in customer orientation, particularly in developing new tools and methods.
  • Accustomed to working independently and as part of a team, being flexible, and adapting to a changing environment.
  • German: fluent in spoken and written communication, English: fluent in spoken and written communication.
Recruiter

  • Robbert Roos
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