JOB SUMMARY:

The Study Operations Manager I (SOM I) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on studies of limited complexity (a small number of countries/sites) or manages portions of a larger study (such as recruitment and retention).

SKILLS

• Expertise in the use of study and site dashboards and reporting tools
• Detail oriented and possesses technical expertise
• Ability to manage moderately complex processes
• Risk identification and mitigation, strategic planning, and critical path analysis skills
• Analytical and problem solving skills
• Ability to adapt to changing technologies and processes, work independently and exercise own judgement
• Supportive of an environment where innovation is standard, including developing ideas and taking appropriate risks to advance innovative processes
• Effective verbal and written communication skills in relating to colleagues and associates, both inside and outside of the organization
• Ability to operate in a matrix environment
• Fluency in written and spoken English required
• Ability to work outside of core business hours, as required, to support global trials or initiatives
• Ability to travel, as required, including Investigator Meetings, vendor kick off and re-set meetings, and client internal global or department level meetings

KNOWLEDGE AND EXPERIENCE:

• 3-5 years clinical trial study management experience in CRO or pharma organization required
• Comprehensive knowledge of own discipline with good knowledge of other disciplines to ensure that the study can meet its goals and to serve as a resource for others
• Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team
• Working knowledge of Good Clinical Practice, clinical and regulatory operations, and environment in countries under responsibility
• Demonstrated clinical research experience and/or study management/startup project manager experience
• Demonstrated experience in managing country level operational activities and/or vendors • Experience in study and quality management
• Knowledge of clinical trial methodology
• Experience working in a matrix management environment
• Relevant operational clinical trial experience

EDUCATION:

• Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operational clinical trial operations experience required OR Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required
• A scientific or technical degree is preferred
  

  LI-CF1

• 6 month assignment with possibility to extend.