Manage the daily operations of the assigned clinical program and associated deliverables, requiring a thorough understanding of the operational and strategic aspects of the project.
Job Details/Main Responsibilities
- Create and implement project plans and guidance documents including clinical monitoring plan, data abstraction guidelines, study reference manual, and training material.
- Organize and provide program training for the study team.
- Oversee all aspects of the clinical operations of the study including site identification, study start up, activation, and enrollment.
- Participate in operations activities as needed (e.g. conducting SIVs, performing site management tasks, data monitoring).
- Manage and lead the project team.
- Be a good steward of company finances by reviewing invoices for accuracy and ensuring they are appropriate to pay.
- Perform other duties as assigned.
Education and Experience
Bachelor's degree, preferably in medical or biological sciences or discipline associated with clinical research. 4 years of related pharmaceutical or biopharmaceutical industry experience, with at least 2 of those years in a clinical operations lead or manager role. Global study management experience preferred.
* An equivalent combination of education and experience may be considered.
Knowledge, Skills, & Abilities
Strong knowledge of Clinical Operations SOPs. Strong sense of initiative; willing to fill gaps as needed. Strong decision making skills and willingness to take accountability. Strong verbal and written communication skills. Strong Microsoft Office skills. Ability to work independently with minimal direction. High achiever with strong track record of delivering. Ability to problem solve in non-traditional ways. Ability to work in a small company atmosphere and all that entails; dynamic environment, high levels of achievement and a strong culture of teamwork.
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