We are currently searching for a Management Analyst 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 Bethesda, MD
Duties & Responsibilities
- Forward safety information communications from study drug manufacturers providing study drug for sponsored clinical trials to program.
- Forward reviewed safety document packages to the program.
- Provide analysis and advisory services regarding management functions.
- Review for completeness all Adverse Event Report packages generated from trials and provided for review and processing.
- Generate monthly analysis reports for documenting reconciliation of adverse event reports sent to program, post on internet portal and distribute to all related clinical sites and contractors for both Study drug manufacturer information and safety reports generated from sponsored trials.
- Perform reconciliation of receipt distribution of safety information at request of staff and or study drug manufacturers.
- Respond to queries regarding safety information received distributed.
- Generate Annual analysis reports documenting activities in support of sponsored clinical trials.
- Facilitate weekly staff meetings, including schedules, generating agenda’s, and updating action items.
- Participate in the clinical study closeout team reviewing and reconciling clinical study files both onsite and offsite.
- Serve as the primary point person for archive files stored for long term storage of regulatory documents.
- Coordinate distribution and tracking of all official Health Authority HA correspondence US and Other.
- Assume responsibility for the file room HA communication, including organization, space allocation and archiving with emphasis on maximal utilization of space.
- Coordinate all incoming documents HA Letter, faxes to include scanning, distribution to the RMC, and filling.
- Assist in the development and approval of project work instructions PWI and standard operating procedures (SOPs).
- Prepare a variety of management and administrative studies to analyze and evaluate internal procedures, policies, processes and systems for the purpose of improving efficiency.
- Analyze information requirements to develop reporting systems including the systems specifications, data gathering and analytical techniques, and systems evaluation methodology.
- Facilitate business process improvement activities, to include documenting as-is processes, gathering to-be requirements and validating capture with staff.
- Assist researching and preparing program and operational strategies and implementation plans.
- Conduct in-depth analysis of all facets of operations, document areas for improvement, research improvement methodologies and recommend course of action.
- Review and suggest new or proposed changes to existing policies, procedures, or systems.
- Analyze and evaluate proposed changes in operating procedures and draft standard operating procedures.
- Develop procedures and systems for establishing, operating, and assessing the effectiveness of administrative controls and systems.
- Document findings of studies and prepare recommendations for implementation of new systems, procedures, and organizational changes.
- Analyze data gathered and develop solutions or alternative methods of proceeding.
- Review policy, regulatory and legal requirements for operation and document gaps and propose corrective actions.
- Prepare reports in the areas of budget, procurement, HR, travel, etc.
- Conduct assessments of standard operating procedures SOP and prepare recommendations for improvement.
- Evaluate operations against standard operating procedures SOP and document gaps or inconsistencies in performance.
- Observe operations and documents standard practices and develop new standard operating procedures SOP and instructions.
- Research and analyze new government policies and regulations that may impact operations and propose actions to ensure operational compliance.
- Assess business strategies and operating plans for consistency with variety of institutional, governmental and industry standards and best practices and draft reports for upper management functional responsibility.
- Prepare reports and presentations for meetings.
- Review administrative audit and investigative reports to determine appropriate changes.
- Prepare detailed reports based on research and findings and present at meetings and briefings.
- Research and suggest developing areas of management policy.
- Attend routine staff and business meetings for awareness and to take notes for distribution.
- Capture meeting minutes and prepare final documentation for distribution to participants.
- Draft reports for review and discussion at working groups and meetings.
- Present information and status updates on projects and studies ongoing within the organization.
- Conduct formal evaluations for operations and performance and prepares reports and dashboards.
- Assists operational and program staff identify, capture and evaluate unique performance criteria.
- Master’s degree in Business Management and Administration, Management Information Systems and Statistics, Multi-Disciplinary or General Science a related discipline or equivalent.
- Minimum of one (1) year of related management experience.
- Excellent skills in oral and written communications and computer competency.
- Minimum of one (1) year of clinical quality assurance experience in health field.
- Experience with taking meeting minutes/summary reports and with meeting coordination.
- Proficient in Microsoft Office Suite.
We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.
The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.
What you’ll get…
- Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
- Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
- Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
- Discovery! With our tuition assistance and training programs, we support your career advancement.
- Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
- Support! Working parents and busy professionals – we’ve got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
- Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
- A Voice! A unique culture where you can influence decisions and have your voice heard.
We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.