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Liaise with Clinical Operations to support company-sponsored studies as agreed upon during study start up. Direct the development and execution of US medical science liaison (MSL) strategies as well as oversight of MSL territory plans.
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Collaborate with scientific communications to establish a platform for collection and dissemination of actionable medical insights. Knowledge of treatment guidelines, clinical research processes, FDA regulations, and Officer of Inspector General (OIG) guidelines preferred.
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Lead study start up process and cross functional planning in support of study start up. Demonstrated experience in study start up and vendor oversight.
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The candidate will be accountable for clinical trial study start up, maintenance and close out, and may assist with study operations, including participant management and data entry, as required.
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This person will work closely with the clinical project scientist team and Clinical Leader in Late Development, in collaboration with other functional disciplines, including GCO, Data Management, Statistics, Regulatory, QMMC, and GMS to ensure flawless and integrated execution of study start-up planning, oversight, and reporting of clinical studies in Oncology.
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Participate in strategic study start-up planning in collaboration with GCO, C&G, and RTAEs including early site assessment, feasibility, and use of simplified contract and budget templates to accelerate rate of site activations.
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Participate in study start up activities. Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports.
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This role is responsible for overseeing all aspects of drug safety study operational activities from study start up to close out. Oversee Drug Safety Study Team Leads activities including review of study protocols, case report forms, Investigator Brochures and participation on IND Annual Reports in support of the Drug Safety Physician.
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Responsible for reviewing and/or approving clinical study documents, such as project timelines, pharmacy manuals, laboratory / PK manuals, informed consent, study start-up plans, monitoring plans, CRFs, data monitoring plan, edit checks, safety plans, DMC charter, close-out plans, and CSRs.
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Penn Medicine's Abramson Cancer Center (ACC) seeks a full-time Director of Clinical Research Finance ('Director') to oversee all clinical research financial activities across the ACC, including expediting study start-up and budgeting, ensuring billing compliance, and aligning financial operations to support and strengthen collaborations among Penn entities.
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The Protocol Project Manager (PPM) will work in the Thoracic Oncology research program and serve as the main point of contact between the study team including faculty and clinical research coordinators (CRC), outside entities such as sponsors, and the Clinical Research Support Office (CRSO), which is a centralized service unit in the HDFCCC offering clinical trial management services.
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Project Manager work includes overall management of research projects, supervision of research staff, regulatory submissions, recruitment strategy, study start-up, performance management, and development of key study documents including protocol, consent, and CRFs. The Project Manager will oversee expenditures and income, negotiate agreements with service providers, and interact with the business administration to ensure income is received and expenditures are paid.
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Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with overall study execution.
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Knowledge of clinical research budgeting and the clinical trial life cycle: study start-up through study closure. The Medicare Coverage Analyst (MCA) is responsible for reviewing clinical research protocols, Informed Consent Forms, Clinical Trial Agreements, and other relevant study-related documents to create a coverage analysis/billing guide.
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You will be responsible for leadership and oversight of all clinical trial activities including vendor oversight and management, from Study Start-up thorough execution and close out of all clinical trials within assigned programs supporting Clinical Development within the R&D organization.
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