LCRA

137735
  • Competitive
  • Germany, Germany
  • Permanent

Lead Clinical Research Associate (CRA) Opportunity

 

Summary:

 

Explore a dynamic career opportunity as a Lead Clinical Research Associate (CRA) at a top pharma owned medical devices organisation. As a forward-thinking individual, you will ensure compliance with international guidelines, local regulations, and corporate policies. Be part of a collaborative team and thrive in a fast-paced environment.

 

Responsibilities:

 

  • Approve study-specific essential documents list.
  • Communicate and manage the status of study progress and activities.
  • Partner with cross-functional teams for query management, data reviews, and resolution.
  • Investigate discrepancies in study documentation using clinical protocol knowledge and GCP.
  • Implement solutions to enhance efficiencies within functional areas.
  • Review documentation for internal and external audits..
  • Conduct site initiation visits and train site personnel on sponsor and regulatory requirements.
  • Monitor sites to ensure clinical aspects align with study protocols.
  • Manage monitoring progress of contract & CRO CRAs for respective sites.
  • Provide input on strategic direction for field monitoring and data collection in complex clinical trials.
  • Oversee clinical trial conduct and manage metrics to ensure protocol compliance.
  • Contribute to the development of clinical protocols, informed consent forms, and case report forms.
  • Verify trial/study data and maintain appropriate regulatory documents.

 

Requirements:

 

  • Proven experience in clinical research, preferably in a lead role.
  • Strong knowledge of international guidelines, GCP, and regulatory requirements.
  • Excellent organizational and communication skills.
  • Ability to anticipate needs and work independently or collaboratively.
  • Ability to travel 50%
  • Experience in monitoring medical devices trials is a plus

 

Benefits:

 

  • Competitive compensation.
  • 13 monthly salary in a year.
  • Dynamic and fast-paced work environment.
  • Opportunity to contribute to ground-breaking clinical trials.
  • Professional development and training opportunities.
Talha Eren Resourcer

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