Clinical Operation Manager Needed, Remote / Work from Home
Clinical Operation Manager needed by our client to co-ordinate clinical study design and implementation at a program and functional level according to Good clinical practice (GCP).
Clinical Operation Manager Qualifications
- Position requires a minimum of a Bachelor of Science degree and at least 5 years of clinical study management experience, including at least 2 years of phase III study management experience (7 years of clinical management experience for Sr. Manager or graduate level education with at least 3 years of clinical study management experience) in clinical research within a pharmaceutical or biotech environment or relevant CRO experience.
- Experience working in therapeutic areas in ophthalmology will be a plus.
- Good understanding of clinical study implementation process.
- Willingness to travel up to 30%, as necessary, consistent with study or functional needs.
Duties and Responsibilities
The duties and responsibilities include but are not limited to the following:
- Responsible for operational input and oversight in designing, planning, initiating and completing phase 3 trials.
- Expected to take the lead in writing clinical documents including study protocols, investigator’s brochures, and clinical study reports.
- Develop and coordinate operational plans for a clinical study or multiple clinical studies within a development program.
- Effectively lead the Clinical Operation Study Team(s) including in-house team members and those from Contract Research Organizations (CROs), vendors and other suppliers.
- Work with various in-house functional groups (including but not limited to Biometrics, Clinical Pharmacology, Drug Supply, Regulatory, Pharmacovigilance, Finance and Legal) with regards to operations issues of clinical studies including, for example, safety reporting and processing and study drug supply plans and monitoring.
- Manage the progress of clinical studies and ensure adherence to study protocols, regulatory and internal operating procedures, intended timelines and budget. This includes reviewing site recruitment, initiation and patient enrollment progress and review and act on trending reports.
- Disseminate clinical project communications to appropriate functional groups
- Duties also may include participating in or leading cross functional initiatives aimed at developing or improving clinical operation process and standard operating procedures as needed under the guidance of the Director of Clinical Operation
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