Workingunder the direction of the Vice Chair for Clinical Trials, and the DepartmentalAdministrator, the Senior Project Manager (SPM) role is a dynamic one,responsible for all activities of clinical trials in the Dermatology ResearchDepartment. This position will proactively manage project level operationalaspects of the Clinical Unit for Research Innovation and Trials (CUReIT)including management of trial timeline, budget, personnel, enrollment and otherresources. The SPM will have theopportunity to oversee cutting-edge industry and investigator-initiatedclinical trials across a breadth of diseases while interfacing withpharmaceutical / biotech experts, research organizations and physicianinvestigators in a multidisciplinary fashion.
Responsibilities:
Will also be responsible for the team's execution on a dailybasis, of the procedural, managerial and policy decisions made for the study.Executes and coordinates daily clinical research activities across a number ofprotocols. Participates in all decisions made for the study and identifiesmodifications of existing policies and procedures. Works across departments andspecialties in multidisciplinary trials. Responsible for budget oversight,training other team members, developing and keeping SOPs current for the unitand participating in supporting grant writing and proposals overseen by thedirector. Oversees the day to day activities of clinical trial coordinator(s),research assistant(s) and CCI/temporary support staff as needed, depending onworkflow fluctuations.
1. Trials operations - The senior project manager is responsible for alloperational aspects of clinical trial oversight including the TIMELY deliveryof every study within budget boundaries. Responsiblefor the coordination and implementation of research design processes and studyprotocols for multiple clinical trials, at multiple sites.
a. Ensuresthat required regulatory documents are completed by the team. Works with the PI and the trial sponsor/contractedresearch organization to complete trial agreements. Communicates effectively and promptly withsponsor contacts and with the PI regarding agreement language. Works to proactively identify issues that maydelay execution of completed agreements. Emphasizes and facilitatescommunication between relevant stakeholders in the pre- and post-enrollment phases of studies.
b. Overseesapplications to the IRB, including new application, amendment, continuingreviews, SAE's, etc. for all new and existing study proposals. Ensures that protocols move through thesystem and receive approval as quickly as possible. Oversees IND and FDAfilings for investigator-initiated studies when appropriate.
c. Workingin concert with the Director, Principal Investigator and/or Clinical TrialsCoordinators, develops and implements patient recruitment strategies. Ensures recruitment goals are met
d. Defines and monitors keyperformance indicators and departmental metrics for Clinical Operations andidentifies opportunities to optimize processes, procedures (SOPs, WorkInstructions) and cost.
e. Provideefficient updates on trial progress to the Director of Clinical Trials,Department Administrator, and/or Administrator.
f. Attendsregular scheduled internal clinical trials meetings as well as any othermanagement meetings at the discretion of the Director of CUReIT and/orDepartment Administrator. Attends orarranges attendance at investigator meetings, if available, together with or inthe absence of a PI, Co-I or other qualified team member.
g. Develops,organizes, and/or maintains the study database. Responsible for data validationand quality control. In conjunction with Principal Investigator, develops andimplements new research protocols including design, data collection systems andinstitutional review board approval.
h. Servesas the primary contact for outside vendors utilized to ensure efficientoperation of the study.
i. Directlyresponds to inquiries regarding study protocol and policy. Serves as liaison to internal and externalpopulation.
i. Mustbe accessible to study participants in order to screen adverse events, concernsand questions related to the investigational drug protocol.
ii. Mustbe easily reachable and 'on-call' (preferably by pager) during assigned workhours to provide study information, screening and, when applicable,point-of-service assistance in carrying out approved protocols.
j. Participatesin all decisions made for the study and the formulation of policies andprocedures. Identifies modificationsneeded and works to implement solutions. Recommends changes to researchprotocols or to unit standard operating procedures. Determinesspecific division of workflow required in each study in order to complete thestudy efficiently, compliantly, and with the welfare and experience of thepatient being the paramount concern.
k. Attendsand participates in investigator meetings, site visits and regular recurringmeetings with trial coordinators and study monitors. Ensures all requireddocuments are ready for any site visit or monitor visit.
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