Posted in Other 3 days ago.
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Posted Job TitleClinical Research Program Manager C (Department of Neurosurgery)
Job Profile TitleClinical Research Program Manager C
Job Description SummaryThe Clinical Research Program Manager will provide leadership, staff and project management, and administrative support for research projects for the program. The position will oversee the daily operations of the unit working closely with other leadership to support the program's clinical research portfolio. The Program Manager is responsible for project development and oversight, staff management, and operational effectiveness of the unit. The candidate will manage relationships between physicians, sponsors, other academic centers, staff, and administrative offices. Candidate will lead operational planning relating to the research activities and ensure optimal communication across stakeholders. The Program Manager will support grant development, participate in facility and contractual issues, and may participate in budget development and management.
Job Description
Job Responsibilities
Staff Management and Development: Recruit, onboard, and manage team including research nurses, project managers, coordinators, and assistants. Provide leadership in the training, assessment, and retention of staff, increase quality of research through training, and provide support to staff across the Department. Help train junior faculty in clinical research. Advise on the most effective way to deploy staff and resources. Promote application of best-practices and efficient resource utilization across team. Conduct regular meetings with team members to review the status of studies, identify outstanding items and troubleshoot as needed. Develop operational processes and best practices to help guide and provide oversight to research personnel, including continuing educational opportunities for staff.
Clinical Trials Operations/Project Management: Lead Project Management on complex clinical research projects, serving both as a consultant and when appropriate continue as the senior lead on projects. Help research teams operationalize more complex research projects from feasibility review, budget creation, regulatory submission through activation and study conduct. Oversee teams consisting of investigators, project managers, coordinators, and assistants. Protocol development, grant development, budget development, study implementation, data reporting, study closeout. Closely monitor the status of all local and multi-institutional clinical research projects/studies conducted within the group, including accrual, data entry, query resolution, deviations and patient issues, identifying and addressing issues as they arise. Provide regular updates to team leadership. Ensure timely completion of project milestones, compliance with regulatory guidelines, accurate reporting to funding agencies and oversight committees, negotiation and proper execution of subcontracts and data use agreements. Develop, create and review regulatory submission and study documents/tools, including protocols, consents, annual reports, source docs, training slides, manuel of procedures (MOPs), Data Safety Monitoring Board (DSMB) charter, Clinical Report Forms (CRFs), standard operating procedures (SOPs). Provide assistance with Investigational New Drug (IND), Investigational Device (IDE) and Clinical Trial Agreement (CTA) exemption determinations.
Program Leadership: Provide administrative leadership and oversight to project leads and teams. Work with Director to develop, organize, maintain, and manage the research staff infrastructure and resources necessary for supporting a quality clinical trials program. Demonstrate an ability to lead and motivate a team with vision, integrity and flexibility. Develop and maintain tools & best practices to support clinical research within unit. Work closely with the Director to ensure effective utilization of materials, staff, and financial resources in alignment with the strategic goals of the Department. Develop and implement project tracking and reporting processes. Design and implement approaches to further grow and expand the unit with successful research collaborations and projects. Assist Director in development of new pathways for clinical research training and education.
Perform additional duties as assigned.
Qualifications
Bachelor's degree and 7-10 years of related experience or equivalent combination of education and experience is required. Master's degree and 5-7 years of experience preferred.
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and
the pay range assigned to the job profile.
Cigna |
Grifols |
Becton Dickinson NA |
Prologis
$98,000.00 - $134,000.00 per year
|
Prologis
$180,000.00 - $250,000.00 per year
|
Prologis
$21.63 - $29.80 per hour
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