The University of Maryland, Baltimore (UMB), Center for Vaccine Development and Global Health (CVD) brings together more than four decades of innovative and life-saving research on vaccines and infectious diseases. http://www.medschool.umaryland.edu/cvd/
As an organized research center within the University of Maryland School of Medicine (UMSOM), CVD comprises a multi-disciplinary team of faculty and staff whose primary mission is to develop, evaluate, and implement vaccines and other interventions to reduce illness and mortality domestically and in less developed countries. We work to prevent and treat respiratory (including influenza) and enteric diseases; to reduce the threat of malaria and antimicrobial resistance; and to identify, understand and combat other tropical and emerging pathogens.
The CVD is seeking a Clinical Program Manager to join our team. The position will provide high level administrative and program oversight for large clinical research initiatives. This hire will assist in the development, implementation, tracking, analysis and writing phases of clinical trials and related research, working independently on administrative and technical tasks while ensuring close communication with the Principal Investigator(s) and Nurse Managers. The hire will combine an understanding of the principles, technical, and scientific aspects of clinical trials with expertise in project management. Excellent oral and written communication skills are needed to interact regularly with financial personnel, research program directors, clinical and laboratory investigators and staff, and study sponsors at NIH and elsewhere.
This position will collaborate closely with the Director, CVD, the internal study team and external collaborators at sponsor and coordinating institutions, and will serve as a liaison between CVD team members, collaborators, subcontractors and sponsor representatives. Additional responsibilities include: tracking resource utilization; reviewing staff needs; ensuring university, federal, state and NIH compliance; working closely with the finance team; and monthly and annual reporting, as required by the sponsor.
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, 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).
Develop/review of clinical protocols and informed consent documents (CDs), case report for (CRFs), SOPs and other trial related documents.
Assume responsibilities for clinical project management components related to oversight and monitoring the progress of clinical trials according to set schedules and milestones.
Coordinate activities of contract with interrelated activities of other programs, departments or staff to ensure optimum efficiency and compliance with appropriate policies, procedures and specifications.
Prepare monthly reports on contract activities, progress, status or other special reports for management or outside agencies.
Initiate subcontract requests and work with finance team to oversee subcontract performance and spending.
Maintain understanding of and program compliance with FDA regulations, ICH guidelines, in-country and regional regulations to ensure that operational activities of clinical trials adhere to GCP, FDA or equivalent as well as CVD policies.
Promote timely decision making and information transmission among members of the study team.
Proactively identify and anticipate barriers or delays in research activities, and work with internal and collaborating investigators in problem resolution efforts.
Review Requests for Proposals from the sponsor and coordinate the writing and submission of these.
Support the identification of potential risks to study conduct and support the development of risk management/mitigation plans for clinical studies.
Participate in teleconferences with other sites and funders.
Evaluate contract effectiveness to develop improved methods of contract execution.
Performs other related duties as assigned.
Education: Bachelor's degree in a health related field. Master's degree in related scientific discipline (nursing, epidemiology, public health, etc ) is preferred.
Experience: F our (4) years of experience involving program planning and coordination experience in clinical research.
Supervisory: Two (2) years project management experience
Certification: Clinical Research Professionals certification desirable
Other: No substitution of experience for minimum education requirement.
Knowledge, Skills, and Abilities:
Possesses a knowledge of position requirements and able to perform position in compliance with all requirements/regulations/laws. Ability to maintain high standards with the work being performed and maintain awareness with trends and influences. Assumes personal responsibility for all outcomes; makes effective and timely decisions; and learns how to effectively use technology. Maintains productivity and uses knowledge strategies to increase knowledge base. Skill in the use of relevant software such as Microsoft Office (Word, Excel, PowerPoint), and project management software.
Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Writes and presents information in a clear and concise way. Interprets and understands written information and is able to listen attentively to verbal and non-verbal cues that lead to a deeper understanding. Strong analytical and problem-solving skills
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.
UMB is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law or policy.
Job: Reg or CII Exempt Staff - E1432F
Employee Class : Exempt Regular
Full Time/Part Time: Full-Time
Shift: Day Job
Financial Disclosure: No
Organization: School of Medicine - Department of Medicine
Job Posting: Jan 30, 2020
Unposting Date: Ongoing
Internal Number: 144541
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.