Will “Clinical Program Manager” be Replaced By Robots? 🤔
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Job Description
Plan, direct, or coordinate clinical research projects. Direct the activities of workers engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives. May evaluate and analyze clinical data.
Job Details
- The SOC (Standard Occupational Classification) code is 11-9121.01
☝️ Information based on the reference occupation “Clinical Research Coordinators”.
Also Known As…
- Clinical Research Coordinators
- Research Coordinator
- Clinical Trial Manager
- Clinical Trial Coordinator
- Clinical Research Nurse Coordinator
- Clinical Research Manager
- Clinical Research Coordinator
- Clinical Research Associate (CRA)
- Clinical Research Administrator
- Clinical Program Coordinator
- Research Associate
- Regulatory Coordinator
- Development Coordinator
- Development Associate
- Clinical Trials Specialist
- Clinical Trials Manager
- Clinical Trial Associate
- Clinical Support Specialist
- Clinical Study Manager
- Clinical Researcher
- Clinical Research Specialist
- Clinical Research Monitor
- Clinical Research Director
- Clinical Research Assistant
- Clinical Project Manager
- Clinical Program Manager
- Clinical Operations Specialist
- Clinical Manager
- Clinical Data Coordinator
Tasks for “Clinical Program Manager”
- Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
- Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
- Develop advertising and other informational materials to be used in subject recruitment.
- Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
- Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
- Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
- Code, evaluate, or interpret collected study data.
- Arrange for research study sites and determine staff or equipment availability.
- Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
- Communicate with laboratories or investigators regarding laboratory findings.
- Direct the requisition, collection, labeling, storage, or shipment of specimens.
- Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
- Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
- Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
- Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
- Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.
- Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
- Contact industry representatives to ensure equipment and software specifications necessary for successful study completion.
- Participate in the development of study protocols including guidelines for administration or data collection procedures.
- Contact outside health care providers and communicate with subjects to obtain follow-up information.
- Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
- Organize space for study equipment and supplies.
- Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
- Register protocol patients with appropriate statistical centers as required.
- Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
- Confer with health care professionals to determine the best recruitment practices for studies.
- Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary.
- Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
- Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.
- Participate in preparation and management of research budgets and monetary disbursements.
- Solicit industry-sponsored trials through contacts and professional organizations.
- Inform patients or caregivers about study aspects and outcomes to be expected.
- Order drugs or devices necessary for study completion.
Related Technology & Tools
- Photocopiers
- Laptop computers
- Laser facsimile machines
- Smartphones
- Digital video equipment
- Personal computers
- Microsoft Access
- Microsoft PowerPoint
- SPSS
- Project management software
- Online data collection systems
- ClearTrial
- Invivo Data EPX ePRO Management System
- PPD Patient Profiles
- InforSense InforSense
- Budgeting software
- StataCorp Stata
- SAS
- StudyManager Sponsor Edition
- TOPAZ Enterprise Software Suite
- Microsoft Excel
- Web browser software
- Phase Forward InForm GTM
- InferMed MACRO Electronic Data Capture
- Sierra Scientific Software CRIS
- PPD eLoader
- Qualitative analysis software
- Scheduling software
- Drug coding software
- OpenClinica
- ePharmaSolutions eMVR
- FileMaker Pro
- Microsoft Outlook
- The MathWorks MATLAB
- Oracle Clinical
- Clinical data management system CDMS
- 5AM Glassbox Translational Research
- Microsoft Project
- Patient tracking software
- Electronic data capture EDC software
- KIKA Veracity
- Microsoft Office
- PercipEnz Technologies OnCore-Clinical Research Management OnCore-CRM
- Microsoft Word
- SyMetric Sciences SyMetric
- DZS Software Solutions ClinPlus