Tasks

- Responsible for building and developing the start up and trial monitoring team in Poland
- Builds partnerships with FSP vendors
Oversight of study start up and monitoring in Poland to:
- achieve timely and complete IRB/EC submissions
- ensure TMF completeness prior to handover from Start Up to Monitoring team
- ensure successful delivery of country site commitments,
- Performs accompanied visits of CRAs to assess their performance
- Builds knowledge of clinical site capabilities in Poland to optimize site selection
- Establishes effective site relationships with key sites in Poland
- Collaborates with other Clinical Operations functions
- Collaborates with other line functions
- Collaborates with other countries to support process improvement, knowledge sharing and team work
- Provides ongoing mentoring and training to study start up and trial monitoring teams
- Assists in maintaining and updating company-level investigator database
- Leads initiatives and workstreams within Monitoring Excellence, as required
- Provides input into SOP development that impact on Monitoring Excellence
- Contributes to Clinical Operations strategy and performance against key metrics

Qualifications

- Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline
- Minimum of 14 years progressive experience in clinical operations, preferably within the biotech/ pharmaceutical sector within Poland
- Solid leadership and management experience, experience in therapeutic area (oncology) is highly recommended
- Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
- Ability to work independently and effectively handle multiple priorities in a fast-paced environment
- Excellent interpersonal skills, strong organizational skills and effective written and verbal communication skills across all levels within an organization
In depth understanding of clinical trial landscape (trial sites, regulation, patient flows,..) in Poland