Clinical Trial Manager

Description

The Clinical Trial Manager (CTM) provides operational expertise and leadership to multiple clinical trial teams, to ensure the effective and efficient delivery of all aspects of multiple studies, through all phases of clinical study management, in accordance with applicable Veristat Policies, Standard Operating Procedures (SOPs), conventions and instructions, as well as current. Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and applicable local regulations.

Qualifications

Highest qualification: University

• Bachelor’s Degree required; degrees in health sciences strongly preferred.
• 5 or more years of experience as a CRA in a CRO or Pharmaceutical setting, and ability to effectively lead a project team required.
• Thorough knowledge of clinical operations, clinical development process, and ICH/GCP and regulatory environment required.
• Ability to serve as a mentor, coach and trainer for assigned CRAs.
• Excellent oral and written communication skills in English, including proficient presentation skills required to effectively support and manage exchanges with external customers; ability to speak and write in other languages a plus.
• Proficient knowledge of study specific therapeutic area to enable appropriate input to study documents (e.g., protocols, CRFs, EDC development)
• Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint required.
• Proficiency in, and ability to learn new, clinical systems including EDC, IVRS, CTMS, eTMF and other clinical project management tools required.
• Ability to self-motivate, be a team player, and work independently.
• Excellent critical thinking and problem-solving skills required.
• Ability to self-motivate, work collaboratively within a team, proactively manage workload, and manage competing priorities in a fast-paced environment required.