he Public Health & Scientific Research (PHSR) Operating Unit (OU) of DLH Holdings Corporation works to improve public health worldwide by providing technical, research, and program management services to government, nonprofit, and commercial clients. The PHSR team offers a synergy of expertise in clinical research services, epidemiology and public health studies, health data management and analysis, and program evaluation and policy analysis. DLH has over 2,000 employees. Please join our dedicated staff in an environment that values diversity and supports health, well-being, and professional growth.
PHSR/SSS is seeking a fully bilingual (English/Spanish) Clinical Operations Manager. The COM will be responsible for coordinating clinical research site participation in National Institutes of Health (NIH) - funded research through the management of administrative aspects of protocol development, site selection and preparation, and site implementation of clinical trials. Candidate must be comfortable working in a fast paced environment and proficient in English/Spanish (fully bilingual).
Key duties and responsibilities may include, but are not limited to, the following:
Manage all site development and oversight activities including project planning, developing processes and tools, and overseeing, training, and mentoring staff in the conduct of, the following activities:
Conducting site assessments, determining site needs, and developing and facilitating action plans to coordinate all activities that support site preparedness for protocol activation, implementation, and closeout.
Drafting and coordinating development of site resources such as standard operating procedures (SOPs), quality management plans, site/study management tools, and informed consent documents.
Assisting in review and development of protocols, Manuals of Procedures (MOPs), and other protocol support documents.
Oversight of tracking and reporting on site progress, working closely with site staff to resolve issues impacting site performance, and serving as a point of contact for sites needing information, advice, or other technical assistance.
Tracking and facilitating the regulatory document review process, including reviewing and filing documents to ensure compliance with regulatory requirements.
Organizing, scheduling and coordinating clinical research site staff training and educational efforts. Participating in development of training and educational materials and general training curricula suitable to specific study and site needs.
Coordinating site assistance required for remedial or corrective action required as a result of performance evaluation, monitoring, or auditing.
Supervise PHSR LaRed Clinical Specialists; provide guidance to Clinical Trial Monitors and function as Monitor as needed of clinical research sites in compliance with all applicable regulations, including site initiation visits, interim monitoring visits, and closeout visits.
Participate in interviewing, hiring, and evaluation of staff.
Coordinate the development and management of a project portal.
Draft Network policies, procedures, and guidance documents. Coordinate with all relevant parties to gain necessary consensus, approvals, and provide necessary follow-up training and education.
Facilitate and manage project meetings, conference calls, and training events.
Conflict and problem resolution: Anticipate and identify potential problems and propose preventive measures and solutions. Identify and implement measures to facilitate process improvement.
Coordination with clinical trial sponsors, consultants, and other contractors and regulatory agencies: Lead conference calls and meetings and track completion of project action items. Serve as a representative of the project and DLH, communicating professionally and effectively with the client and all collaborators.
Project management: Oversee aspects of project activities, contribute to project planning, review budgets and draft budget justifications, and contribute to client deliverables through activities such as maintaining project timeline, providing weekly client operations updates, and contributing to monthly client progress reports.
Additional duties as assigned.
Approximately 10% Travel
Demonstrated fluency in English and Spanish
Competently manage a very heavy workload, and multiple projects with competing priorities, switching priorities quickly as needs change. Must be comfortable working in quick-paced environment.
Demonstrate a very high level of technical skill and expertise as pertains to clinical research site support and development.
Demonstrate high proficiency in project planning and organization and proactively anticipate and identify complex issues and problems.
Demonstrate exceptional interpersonal skills and written and verbal communication abilities.
Demonstrate excellent decision-making abilities with competency in resolving problems that could have an impact on the project and/or the company.
Recognize which decisions may have a consequential effect on the project and/or the company and make decisions based on experience, skill, and situation, consulting with
and/or informing others as appropriate.
Act as the spokesperson for the project/company and consider the implications of input/decisions, ensuring they are communicated appropriately.
A baccalaureate degree from an accredited college or university. A master’s degree or equivalent is preferred.
Relevant experience or coursework in public health, biomedical research or other related field.
A minimum of 7 years of increasingly responsible, broad and diversified professional experience relevant to managing projects or implementing clinical trials, research, or biomedical training programs.
Proficient in Microsoft Office Software packages
Familiar with Clinical Trials data management software packages
Fully bilingual (English/Spanish) writing and speaking
DLH is committed to fostering a diverse workforce and is proud to be an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
DLH provides technology-enabled business process outsourcing and program management solutions, primarily to improve and better deploy large-scale Federal health and human service initiatives. DLH delivers professional healthcare and public services to several Government agencies including the U.S. Department of Defense, U.S. Department Health and Human Services, U.S. Department of Veterans Affairs, National Institutes of Health (NIH), Centers for Medicare and Medicaid Services (CMS) and many more.