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Study Manager
2 weeks ago
**Job Summary**:
The role of the Study Manager is to plan and oversee all activities of assigned clinical trials. The SM is required to collaborate with project managers, principal investigators, clinical research associates, and the clinic team/sites. The SM will provide study progress updates to Sponsors and the internal project team. They will frequently communicate updates regarding trial progress and maintain a high degree of ongoing project correspondence with the Sponsor and Project Manager. In essence, the Study Manager will oversee the operations & conduct of the clinical study from start to finish.
**Responsibilities**:
- Oversees all aspects and tasks of a clinical trial from planning to close-out (budget, resources, supplies, third-party vendors, metrics, reporting).
- Acts as the main point of contact for any project issue/query raised by the project team or Sponsor.
- Liaises with PI to ensure clinical trials are conducted safely.
- Forecasts the necessary resources for current and upcoming clinical trials and allocates tasks according to budgeted hours.
- Acts as the liaison between the Project Manager and the clinic team.
- Collates and reviews operational input in requests for proposals.
- Monitors invoices and budget spent vs allocated.
- Prepares, oversees, and reviews clinical trial documents.
- Works hand-in-hand with other team members to manage study IPs/IDs, documents, templates, logs, etc.
- Monitors and reports clinical trial progress to PM and Director of Operations.
- Assists QA in the conduct of internal audits.
- Provides protocol-specific training to the clinical team.
- Reviews invoices from vendors and external consultants.
**Job Requirements**:
- Bachelor’s degree in Sciences, Health Sciences, or Nursing.
- Minimum of 5 years of experience in clinical trials (at least 3 years of project or study management experience).
- Exceptional interpersonal and communication skills, professionalism, and strong work ethic.
- Ability to work individually and as part of a team, including the ability to motivate and organize a diverse team.
- Accountable and accurate, with strong attention to detail.
- Comfortable with handling sensitive and private information.
Must be able to work with little or no supervision, within strict deadlines, and must be able to manage multiple projects simultaneously.
