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Associate Director Gco Country Head Emerging Markets
vor 2 Wochen
General Description:
- Responsible for directing clinical operations-related activities in the East EU countries, within the EMEA Emerging Markets Cluster- Helps direct the country clinical operations teams in East EU countries to achieve excellence and meet performance KPIs in study start up, monitoring, feasibility and country study management deliverables- Acts as line manager for study team staff at the country level (which may include SSUS, CRA, CTMA, CSM and line managers as applicable) in East EU countries, within the EMEA Emerging Markets Cluster- Responsible for the management and implementation of resources in East EU countries- Partners with both internal and external stakeholders such as medical affairs, clinical development and other functions such as CBO or Clinical Supplies, as well as with clinical sites, Key Opinion Leaders to establish BeiGene GCO as a collaborative partner for clinical trials in East EU countries,- Demonstrates a high level of knowledge of clinical operations, organizational skills and project management competencies- Implements best practices and shares lessons learned with team and other colleagues, as appropriate- Ensures consistency in processes and drives Country Clinical Operations performance in East EU countries- Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs- Works to high quality, maintains a positive and results orientated work environment
Essential Functions of the job:
- Responsible for managing the country clinical operations team in East EU countries, including the hiring, training, development and resource allocation of BeOne staff and oversight of FSP staff- Build partnerships with FSP vendors to allow optimal resource utilization of FSP staff- Oversight of study start up and monitoring in East EU countries 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, i.e. achieving site activation and enrolment goals within planned timelines, as well as maintaining inspection readiness- Performs accompanied visits of CRAs to assess their performance, if required- Build knowledge of clinical site capabilities in East EU countries to optimize site selection- Establishes effective site relationships with key sites in East EU countries to optimise timelines, recruitment, quality and overall performance- Collaborates with other Clinical Operations functions (e.g. Study Management) to support successful planning and execution of clinical trials- Collaborate with other line functions (e.g. Medical Affairs, Commercial) to support site relationships and build a strong presence of BeOne.- Collaborate 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 and other functional areas as needed- Assists in maintaining and updating company-level investigator database- Help direct initiatives and workstreams within GCO EMEA, as required- Provides input into SOP development that impact on the Country Clinical Operations organisation, as required- Contributes to Clinical Operations strategy and has direct oversight and influence on East EU countries country performance against key metrics
Supervisory Responsibilities:
- Ensure the competencies and skills required for the country study teams in East EU countries are consistent with the company defined requirements- Conduct mid-year and year end performance appraisals for direct reports which includes providing constructive feedback as well as oversight of subordinate team’s performance
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Other Qualifications:
- 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 the Emerging Markets Countries
Travel: up to 10-15%
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, s
