Clinical Operations Manager
We are currently searching for a Clinical Operations Manager to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and it is on-site in Rockville, MD.
Duties & Responsibilities
- Serve as an advisor to the Director and Deputy Director on administrative and operational issues.
- Collaborate with Program staff to plan and coordinate programmatic activities for high priority science (i.e. HIV and HIV-associated coinfections and comorbidities).
- Participate in the review, planning, and implementation of clinical trials under program purview.
- Track all planned and ongoing clinical trials and provides the framework and tools for trial documentation.
- Coordinate clinical review activities/meetings for the program portfolio, including support for the Clinical Science Review Committee and pre-review activities for the Data Safety and Monitoring Boards.
- Serve as the liaison to clinical trial-related working groups led by NIH programs.
- Stay abreast of new clinical research policies being developed and ensures program is aware and provides input, as appropriate, for draft policies and procedures.
- Work closely with the Regulatory Affairs Branch on regulatory and protocol registration issues as appropriate for clinical trials.
- Coordinate internal audit preparation and responses; Communicates audit responses with other scientific programs and offices within NIH.
- Conduct internal program evaluations for the Quality Management System.
- Assist with the development of new and/or update of existing policies and procedures, as required.
- Provide centralized support for NNCTs, including coordinating site activation activities with relevant staff.
- Assist in the development of risk management plans and mitigation of identified risks.
- Minimum of a B.S./B.A. degree and ten (10) years of experience in clinical trial management including budget management.
- Knowledge of regulations, policies, procedures and guidelines governing clinical research.
- Knowledge of clinical practices in order to conduct evaluations for quality management, coordinate site-activation activities, and render internal audit preparations.
- Ability to analyze problems and to make decisions/recommendations for resolving those problems.
- Knowledge of Microsoft Office Suite (MS Word, Excel, Outlook) and spreadsheet applications.
- Strong communications skills, both oral and written.
- Excellent analytical, organizational and time management skills.
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.
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