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Director, Team Lead, Trial Management

Responsibilities

  • Set the direction and inspire/motivate your employees to deliver the best in a fast-paced environment

  • Drive and lead successful execution of all operational aspect of global clinical trials/program using strong project management, leadership, and organizational skills

  • Accountable for operational execution to support a diverse portfolio of work while proactively managing risks and issues

  • Provide technical and strategic expertise to ensure consistent processes

  • Support development of the global clinical trial budgets and review of workorders focusing on cost efficiencies, quality, and timelines

  • Communicate regularly and effectively with relevant stakeholders including but not limited to clinical, regulatory, safety, project management, and other internal and external stakeholders

  • Promote collaborative relations with stakeholders, vendors, consultants, and CRO’s in a global setting

  • Management of resources across projects/activities

  • Contribute to development of processes within Clinical Operations in accordance with new trends/standards and ICH-GCP guidelines

  • Vendor management at the operational and strategic level

  • Data process knowledge and strong IT skills with a passion for e-tools/digital devices would be an advantage

  • KOL engagement

  • Support development of improved start up processes

  • Act as Clinical Project Leader (CPL) for one or more compounds

  • Contribute to the development of clinical operational strategy/development plan within that portfolio of work

  • Work collaboratively with colleagues/partners in EU, US and Japan and bring cultural diversity into play
     

Requirements

  • Background within natural science and a scientific mindset

  • A minimum of 10 years of experience within Trial Management preferably 3 years of managerial experience leading highly competent and dedicated team

  • Track record in driving clinical trials phase I-IV

  • Experience with Risk Based Monitoring

  • Extensive experience with startup activities

  • Ability to work in a matrixed organization

  • Knowledge of FDA, EMA, PMDA, and ICH guidance for drug development pertaining to Trial Management

  • Excellence in planning and execution of clinical trials within trial timelines

  • Experience with the relevant regulatory requirements in relations to processes and SOPs
     

Moreover, you meet the following:

  • Demonstrated ability to work independently, handle multiple priorities within timelines, and collaborate with other functions to resolve issues and improve efficiency

  • Excellent inter-personal skills in management, collaboration, and communication to managers, colleagues, team members, CROs, and external collaborators

  • Go do attitude, creative, proactive, enthusiastic, out-of-the-box thinking, and goal orientated

  • Significant experience managing to deliver results

  • Demonstrated ability to collaborate with a diverse and global group of people including but not limited to data managers

Degrees of interest: Background within natural science and a scientific mindset

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