Clinical Study Leadership

7 dni temu

Warszawa, Mazovia, Polska TN Poland Pełny etat

Study Manager Position:

We are looking for an experienced Study Manager to join our global study team. In this role, you will be responsible for managing clinical studies from start to finish, working closely with internal and external stakeholders to ensure successful study delivery.

You will oversee study execution, prepare delegated study documents, and maintain relationships with internal and external functions. Strong leadership and communication skills are essential for this position, as you will work across different departments and geographic locations.

Main Responsibilities:

  1. Manage clinical studies from start to finish, including study set-up, maintenance, close-out, and archiving.
  2. Prepare delegated study documents, such as informed consent forms and master clinical study agreements.
  3. Maintain relationships with internal and external functions, including enablement teams, data management, procurement, regulatory, patient safety, and quality assurance.
  4. Support planning and conduct of internal and external meetings (Investigators'/Monitors' meeting).
  5. Liaise with Clinical Supply Chain or external service providers to ensure Investigational product and study material supply.
  6. Identify and mitigate risks and issues, and implement corrective actions.
  7. Ensure all study documents are complete and verified for quality in Trial Master File.
  8. Support budget management, including external service provider invoice reconciliation.
  9. Adhere to global clinical processes, procedural documents, and international guidelines to ensure study inspection readiness.
  10. Take on assignments related to process improvements and leading improvement projects.

Requirements:

  1. Relevant experience in pharmaceutical industry or similar organization, preferably 3+ years - knowledge of clinical development/drug development process in various phases.
  2. Excellent communication and relationship building skills, including external service provider management.
  3. Knowledge of international guidelines ICH/GCP.
  4. University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
  5. Demonstrated ability to collaborate and work independently.
  6. Leadership skills.
  7. Computer proficiency and advanced computer skills.
  8. Excellent verbal and written communication in English.

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