The University of Maryland, Baltimore (UMB), Center for Vaccine Development (CVD) in the University of Maryland School of Medicine, Pediatric Infectious Disease and Tropical Medicine, is seeking a Program Manager to oversee and manage a large international epidemiologic study . The Program Manager will play a pivotal role in the design, implementation, analysis and writing phases of the project, will prepare reports and publications, and work independently on administrative and technical tasks while providing regular reports back to the Principal Investigator. This position will collaborate closely with the study teams in both Baltimore and abroad, and also with collaborators at sponsor and coordinating institutions. The position will be involved in other projects at the Center for Vaccine Development contingent on need and interest.
This position will require travel to the research site in Africa (20% of the time).
UMB offers a generous benefits package that includes 22 vacation days, 14 floating and holidays, 15 sick days; comprehensive health insurance and retirement options; and tuition remission for employees and their dependents at any of the University System of Maryland schools.
Develop and track work flow policies, milestones, deliverables, maintain documentation on study history and decisions, supervise expenditures and subcontracts, serve as a point of contact for key internal and external collaborators, and track progress through the duration of the research study or clinical trial(s).
Assist Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing research studies or clinical trials.
Promote timely decision making and information transmission among members of the study team.
Travel to study site to build relationships with partners, train on-site workers, oversee study progress, and resolve administrative issues.
Develop and direct development of study documents such as standard operating procedures, informed consent forms, case report forms, as well as study databases.
Responsible for developing and producing custom and routine reports.
Monitor activities to ensure compliance with protocols and all relevant local, federal, and state regulatory and institutional policies.
Continuously educate and train personnel on compliance and protocol.
Identify protocol problems, work with collaborating investigators in problem resolution efforts.
Create and direct creation of rules for data cleaning and error checking.
Assist in drafting submissions to institutional review board, responding to questions and ensuring compliance with Good Clinical Practice (GCP) at study sites.
Manage complex study or trial data. Develop methods for collection, database storage, tracking, analysis, and interpretation of data. Perform primary and secondary analyses of study data using standard statistical techniques.
Create figures and charts suitable for publications and reports.
Compose papers and reports in collaboration with internal and external stakeholders.
Review proposed study protocols to evaluate factors such as sample collection process, data management plans, and potential subject risks. Conduct quality assurance audits on data and regulatory documentation.
Assist in budget development, expenditure adherence, grant applications, and maintenance of inventory on equipment and supplies.
Provide training and guidance to less experienced personnel.
Attend research study or clinical trial related meetings, conferences and teleconferences, as well as participating in any additional planning and development related activities.
Perform other related duties as assigned.
Education: Bachelor's degree in epidemiology, public health, chemistry, biology, anthropology or another scientific discipline appropriate to position required.
Preferred: Masters or PhD in epidemiology or public health or equivalent degree in a related field is preferred.
Experience: Four (4) years of program oversight including program planning, budgeting, and coordination, preferably in a research setting.
Other: May require training related to occupational safety and health, environmental compliance, shipping of hazardous materials and/or ionizing radiation.
Knowledge, Skills, and Abilities
Possesses a knowledge of design and implementation of epidemiologic studies and analysis of epidemiologic data. Ability to perform position in compliance with all requirements, regulations, and laws. Ability to understand and utilized scientific/medical terminology and research theory. Ability to extract appropriate data to convey complex information through the use of supporting tables, graphs and other visual representations. Ability to gain knowledge and meet the reporting needs of University policies and practices for Institutional Review, Human Protections, Animal Protections, etc. Ability to maintain high standards with the work being performed and maintain awareness with trends and influences. Assumes personal responsibility for all outcomes. Skill in making effective and timely decisions. Ability to effectively use technology. Ability to track technical and financial activities and milestones. Ability to maintain productivity. Skill in continuously seeking to improve the quality of services and processes. Ability to organize/prioritize work and meet deadlines within a fast-paced environment with multiple and competing demands. Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Write and present information in a clear and concise way for reports to sponsors and scientific publication. Interpret and understand written information and listen attentively to verbal and non-verbal cues that lead to a deeper understanding. Ability to work cooperatively with others and demonstrates professional, ethical, respectful, and courteous behavior when interacting with others. Capable of interacting pleasantly and positively with other to meet customer expectations, and provide follow up with customers.
Hiring Range: Commensurate with education and experience
If accommodations are needed for a disability, please contact Staffing & Career Services at 410-706-2606, Monday – Friday, 8:30am – 4:30pm EST. Maryland Relay can be accessed by dialing 711 (in-state) or 1-800-735-2258.
Equal Opportunity/Affirmative Action Employer. Minorities, women, protected veterans, and individuals with disabilities are encouraged to apply.
Job: Reg or CII Exempt Staff - E1430F
Employee Class : Exempt Regular
Full Time/Part Time: Full-Time
Shift: Day Job
Financial Disclosure: No
Organization: SOM Ctr for Vaccine Development
Job Posting: Mar 13, 2018
Unposting Date: Apr 2, 2018, 3:59:00 AM
Internal Number: 83941
About University of Maryland, Baltimore
The University of Maryland, Baltimore (UMB) is the State's public health, law and human services university devoted to excellence in professional and graduate education, research, patient care, and public service. As a diverse community of outstanding faculty, staff and students, and using state-of-the-art technological support, we educate leaders in health care delivery, biomedical science, global health, social work and the law. We emphasize interdisciplinary education and research in an atmosphere that explicitly values civility, diversity, collaboration, teamwork and accountability. By conducting internationally recognized research to cure disease and to improve the health, social functioning and just treatment of the people we serve, we foster economic development in the City, State, and nation. We are committed to ensuring that the knowledge we generate provides maximum benefit to society and directly enhances our various communities.