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Sr. Clinical Project Manager
Custom Search, Saint Paul, Minnesota, United States, 55130
Our small start-up client is adding a Sr. Clinical Trial Manager (CTM) to the team! The CTM will report to the Executive Director of Clinical and will play a critical role in conducting a successful clinical study. As an internal and externally facing position, this position interacts directly with the internal study team, regulatory affairs, legal, marketing, and R&D, along with clinical vendors, physician consultants, clinical Investigators, and other study staff at a clinical research site. The CTM will oversee the execution of the study to ensure patient safety, maintain the quality and. integrity of the study data, and meet good clinical practice requirements.
Your role with the company:
Responsible and accountable for one or more clinical studiesCoordinate all aspects of the clinical study from study start-up through closeoutManage the clinical studies within the approved budgets and timelinesCollaborate with clinical advisors during the development of a clinical protocolMay participate on a cross-functional core team to support the ongoing development of the study deviceSupport the identification of clinical vendors such as CROs, core labs, or othersManage deliverables agreed to with chosen clinical vendors to ensure adequate delivery, quality, timeliness, and cost-effectivenessOversee the investigator and investigational site selection processDevelop clinical study documents such as protocols, CRFs, training materials, informed consent, operational plans and required formsManage forecasting and accountability of study devicesDevelopment, tracking, and report out of study metricsIdentification and escalation of potential patient safety concerns, compliance issues, and other study risksResponsible for ensuring the audit-readiness of the study throughout the study durationDesired Profile:Bachelor's degree in life sciences, biological sciences, pharmacy, nursing, biomedical engineering, or related fieldMinimum 5 years of clinical research experience with at least 1 year of project management responsibilitiesKnowledge of good clinical practices, ICH, HIPAA, and other applicable clinical trial-related regulationsExperience with pre-market IDE clinical trials (Feasibility and Pivotal preferred)Ability to provide clear direction and guidance to othersStrong communication, interpersonal, and problem-solving skillsExcellent organizational and time management skillsProven ability to work independently in a fast-paced environmentAbility to travel up to 35% primarily within the US
Your role with the company:
Responsible and accountable for one or more clinical studiesCoordinate all aspects of the clinical study from study start-up through closeoutManage the clinical studies within the approved budgets and timelinesCollaborate with clinical advisors during the development of a clinical protocolMay participate on a cross-functional core team to support the ongoing development of the study deviceSupport the identification of clinical vendors such as CROs, core labs, or othersManage deliverables agreed to with chosen clinical vendors to ensure adequate delivery, quality, timeliness, and cost-effectivenessOversee the investigator and investigational site selection processDevelop clinical study documents such as protocols, CRFs, training materials, informed consent, operational plans and required formsManage forecasting and accountability of study devicesDevelopment, tracking, and report out of study metricsIdentification and escalation of potential patient safety concerns, compliance issues, and other study risksResponsible for ensuring the audit-readiness of the study throughout the study durationDesired Profile:Bachelor's degree in life sciences, biological sciences, pharmacy, nursing, biomedical engineering, or related fieldMinimum 5 years of clinical research experience with at least 1 year of project management responsibilitiesKnowledge of good clinical practices, ICH, HIPAA, and other applicable clinical trial-related regulationsExperience with pre-market IDE clinical trials (Feasibility and Pivotal preferred)Ability to provide clear direction and guidance to othersStrong communication, interpersonal, and problem-solving skillsExcellent organizational and time management skillsProven ability to work independently in a fast-paced environmentAbility to travel up to 35% primarily within the US