Ref #: 23437

Employment type: Permanent - Full-Time

Location: Poland

Posted: 02-Oct-2020

Description

Responsibilities:
The position is responsible for the global coordination of clinical trial management activities for internally managed and/or outsourced trials.

Responsibilities:
•Ensure regional/ global clinical operations deliverables progress according to agreed upon timelines and milestones as leader of the Study Management Team (SMT). This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set up activities as assigned.
•Set-up country budgets and monitor actuals vs forecast for Out of Pocket Expenses, and review assigned vendor invoices/spend.
•Establish enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical tial level.
•Create and update study-specific documents such as Monitoring Guidelines, Informed Consent Form.
•Act as the primary contact person for the local teams within organization.
•Establish and maintain excellent working relationships with internal stakeholders, including Local Trial Managers.
•Ensure compliance with global health authority regulations and guidelines and internal operating procedures and processes.
•Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits.
•Management of global vendors.

Requirements:
•Life science degree (preferable)
•Minimum of 3 years clinical trial management experience from start- up to database lock (on regional and global level) in the pharmaceutical industry or CRO
•Experience with supervision of CROs/vendors is preferred
•Strong decision-making and communication/collaboration skills
•Effective leadership skills

What is offered:
•A challenging CTM role in an international Pharmaceutical company
•Permanent office based position (Warsaw or Cracow area) or partially home-based in a stable organization (3 days per week)
•You will enjoy highly competitive compensation and an exceptional benefits package (car allowance, Medicover, fitness reimbursement)
•Home-based opportunity (3 days per week)

If you have the right skills and experience, please send your CV to: dagmara.drozdowska@docsglobal.com or call Dagmara: 668 87 02 61.

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