Inside Higher Ed · 1 day ago
MTA/DUA Study Start-up Program Manager (Office of Clinical Trials)
Baltimore, MD
Full-time
Hybrid
Mid, Senior Level
$56K/yr - $98K/yr
5+ years expInside Higher Ed is seeking a MTA/DUA Study Start-up Program Manager to oversee the operations of the unit responsible for commercial MTA/DUA start-ups. The role involves managing the start-up process, supervising a team, and ensuring compliance with regulations while facilitating collaboration among various stakeholders.
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Responsibilities
Manage the day-to-day operations and staffing of the unit to streamline commercial MTA/DUA start-ups and maximize efficiencies while ensuring adherence to best practices, regulations/guidelines, and Standard Operating Procedures for human subjects protections and protocol integrity
Provide direction and coordination for Commercial MTA/DUA Program
Manage the end-to-end start-up process within the unit, from concept through activation
Supervise team of Commercial MTA/DUA regulatory specialists with activities including onboarding new clinical research operations personnel, performance evaluations, corrective actions, performance improvement plans, and career development
Facilitate effective teamwork among all involved personnel, e.g., regulatory specialists, research study teams, central research administrative personnel, etc
Partner and collaborate with the OCT Accelerated Study Start-up Program which is focused on commercial clinical trials
Provide support, guidance, and training to study teams to facilitate start-up of Commercial MTA/DUA including coordination and initiation of contract activities, initial applications to the IRB and other regulatory agencies, etc
Develop and implement systems for monitoring, reporting, and quality assurance activities
Communicate with and track activities led by internal and/or external research team members and collaborators
Monitor, track, and report critical study start-up milestones, e.g, IRB activities, processing and finalization of contracts, etc., Proactively manage and remove barriers to Commercial MTA/DUA project start-up
Liaison between study teams and central research administrative teams
Anticipate and mitigate risks to Commercial MTA/DUA project start-up
Develop and refine standard operating procedures for Commercial MTA/DUA project start-up activities
Collaborate with the Office of Research Administration in the coordination and initiation of contracts for new Commercial MTA/DUA projects
Contribute to meetings with program stakeholders and provide status updates and recommend changes to operations based on results and goals
Meet with institute- and department-based Research Council Chairs to address needs and concerns regarding new Commercial MTA/DUA project start-up, and communicate these needs, concerns, and action plans to the Director of OCT as appropriate
Represent the Commercial MTA/DUA Program on institute- and department-based Research Councils and other committees, tasks forces, and working groups as assigned or requested
Qualification
Required
Bachelor's Degree in a related field
Five years of related experience in clinical research in an academic, government, or pharmaceutical industry environment
Demonstrated knowledge and skills in accordance with Good Clinical Practice (GCP) guidelines, HIPAA, FDA regulations, and other federally mandated guidelines
Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula
Preferred
Master's Degree in related field
Certification as a Clinical Research Professional
Company
Inside Higher Ed
Inside Higher Ed is the online source for news, opinion, and jobs related to higher education.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2022-01-10Acquired
2006-08-31Series Unknown
Leadership Team
Stephanie Shweiki
Director, Foundation Partnerships
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