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Clinical Trial Operations Manager
2 months ago
About This Position
Make a significant impact in your career with HI-Bio, Inc., a subsidiary of Biogen. As a Clinical Trial Operations Manager, you will be responsible for formulating operational strategies and supervising our clinical research organization (CRO) partners to ensure the development of clear protocol concepts and finalized protocols.
Your Responsibilities
In this role, you will have full or shared accountability for the entirety of clinical trial studies, encompassing operational design, successful execution, and the positive influence on patients suffering from various immune-mediated conditions.
- Independently or collaboratively with other Clinical Trial Leads, create and manage the implementation of the operational strategy at the study level for the effective delivery of clinical trials.
- Lead the Clinical Study Team (CST) meetings to foster the development of scientifically sound, operationally viable, and clear concepts and protocols.
- Offer operational direction to sites, CROs, and other essential suppliers.
- Oversee the operational management of clinical study vendors.
- Coordinate efforts related to study initiation, including site feasibility assessments, site selection, and the distribution of regulatory documentation.
- Participate in scientific conferences.
- Ensure the thoroughness of the electronic Trial Master File (eTMF).
- Supervise the execution of studies by CROs to guarantee quality delivery in accordance with timelines and budget expectations.
- Manage financial aspects, approve invoices, and engage in the monthly accrual process.
- Contribute to the testing of clinical study systems, including Interactive Response Technology (IRT) and Electronic Data Capture (EDC).
- Collaborate with the CRO Senior Management Team lead to ensure the CRO develops appropriate risk mitigation strategies and effectively addresses issues.
Who You Are
You are a scientifically and clinically knowledgeable individual, driven by a mission to make a difference. With a strategic outlook, you possess the ability to see the broader picture and take on responsibilities that extend beyond routine operations. You are decisive, analytical, and self-assured, committed to taking charge of your career and positively impacting the lives of others through your leadership and capacity to inspire excellence.
