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Smiling employee in a conversation with a colleague in the office
Smiling employee in a conversation with a colleague in the office
ID: 121382

Clinical Research Specialist

  • Pharma & Biotech
  • Asap
  • CRA, ICF Review, TMF Filling, Hematology
  • K-Recruiting GmbH
Contact:

Julius Strack

+49 89 1890998-614

julius.strack@k-recruiting.com

Overview

Availability
Asap, full-time, onsite & remote
Qualification
PhD in Pharmaceutical Biology
Language Skills
German (native), English (business fluent), Chinese (fluent)
Relevant Expertise
Clinical Research Associate, ICF Review, TMF, Non-Interventional Studies, Hematology, Good Clinical Practice, Monitoring, Vendor Selection and Management, Clinical Trials, Pharma

Key-Facts

  • Successfully completed various controlling projects

  • Experienced Clinical Research Associate with a demonstrated history of working in the pharmaceuticals industry

  • Highly Skilled in Hematology, Clinical Monitoring, and Good Clinical Practice (GCP)

  • Healthcare Professional with extensive knowledge and experience in multiple therapeutic fields

  • Superior communication skills, collaborative in team settings and highly respected by colleagues and clients

Extract from previous activities

Pharmaceutical Company, Germany (via K-Recruiting)

TMF Filing Specialist

  • Checking the completeness, accurancy and quality of study documents

  • Cross-checking of documents

  • Archiving and entering documents into eTMF submission preparation

  • Partnering and collaborating with Document Specialists and Document Owners

Pharmaceutical Company, Germany

ICF Review Specialist

  • Drafting of ICF country templates which are then distributed to study sites to make edits depending on their local requirements and SOPs

  • Review and negotiate changes and potentially liaise with other stakeholders

Pharmaceutical Company, Germany

Clinical Research Associate

  • Clinical monitoring of current studies

  • Study preparation / Study Start up

  • Qualification & Initiation Visits