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Medical Advisor

  • Creative Pharma Services S.A
  • Αθήνα
  • 1/2/2018

Στοιχεία αγγελίας

Σχέση απασχόλησης - Πλήρης ΑπασχόλησηΕλάχιστη Απαιτούμενη Εκπαίδευση - ΔιδακτορικόΑπαιτούμενη Προϋπηρεσία - Τουλάχιστον 2 έτος/ηΚατηγορίες - Επαγγέλματα Υγείας

Περιγραφή

 

Main Responsibilities

 

The Medical Advisor will provide medical expertise and scientific advice on the various clinical trials as well as other related projects of the Company. Responsibilities also include contribution to the development of medical strategy and provision of medical input and medical guidance/governance for all therapeutic areas of Company’s involvement.

The role in brief: 

  • Act as a medical resource to the company by providing medical expertise and advice for clinical trials and other related projects.
  • Create/write/oversee study protocols, protocol amendments, Informed Consent Forms, CRFs, study manuals, monitoring plans and CRF guidelines.
  • Design or provide input/ advisory to the design of a clinical trial by taking into account all pertinent specifications.
  • Collaborate with the Data Manager or Biostatistician (internal or external) for the design and implementation of summary clinical study reports according to company’s own or sponsor’s dictated SOPs or full clinical study reports according to ICH relevant guidelines
  • Provide protocol training to the investigators and to CRA’s on study familiarization.
  • Attend and provide input to external meetings, advisory boards and symposia.
  • Prepare and organize Investigator Meetings and present trainings.
  • Conduct CRAs’ introduction to clinical trials and provide therapeutic/ drug or protocol specific training of personnel involved in given company’s project.
  • Design and implement tailor-made training courses on clinical research, and medical/ therapeutic areas to accommodate clients’ needs.
  • Maintain an updated view of key therapeutic areas, drug development, and regulatory guidelines, local, European, or global, that may affect the clinical trial design and conduct.

Απαιτήσεις


  • Previous experience as a Medical Advisor in a Medical Affairs department.
  • Medical Degree or PhD in Life Sciences is a pre-requisite.
  • Extensive knowledge of all aspects of drug development, ICH-GCP and EU regulations.
  • Thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs.
  • Fluency in written and oral English.
  • Computer literacy.
  • Problem-solving and decision-making skills.
  • Strong communication and presentation skills.
  • Strong influencing and persuasion skills.
  • Strategic thinking.
  • Results-oriented attitude.

 

What we offer  

Creative Pharma Services is offering a competitive remuneration package according to the Industry’s standards. Nonetheless, we are also proud at Creative Pharma Services that we are an open and learning organization that fosters a collaborative, enthusiastic, fast-paced working environment, but also an employer that invests in people’s potential and growth.


All applications will be treated fairly and with strict confidentiality.



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