Custom Search
Clinical Study Manager
Custom Search, Minneapolis, Minnesota, United States, 55400
Our mid-sized medical device client is adding a Clinical Study Manager to the team! The Clinical Study Manager will report to the Sr. Clinical Manager and will oversee clinical activities related to one or more clinical studies and performing/managing the daily in-house operations associated with the studies. The Clinical Study Manager will work independently on multiple complex clinical studies using critical thinking skills. Will be managing one study in start-up and another on-going study. The new study will have about 70 patients and 5 centers.
Your role with the company:
Responsible for managing clinical studies in accordance with internal standard operating procedures and applicable regulations and guidelinesCollaborate with internal and external clinical team members and consultants to draft clinical study protocols, Instructions for Use, Report of Prior Investigations, Investigational Brochures and other clinical study documentationOversee clinical site selection and activationManage study safety by tracking and reporting adverse events as required by regulatory bodies, reviewing adverse event trends, and overseeing safety committees including Clinical Events Committees and Data Safety Monitoring BoardsOversee monitoring activities related to assigned clinical studies including review and approval of monitoring plan and monitoring reports, managing monitoring schedule and ensuring corrective action related to monitoring findingsDevelop training plans for study training and review/approve training documentationPrepare study-related reports including annual, interim and final study reportsOrganize and lead study-related conference calls and Investigator meetings as needed through the studyOversee investigational device allocation, distribution and reconciliationCollaborate with data management team to ensure appropriate data capture and query managementAssist with and/or perform data analysisUse critical thinking skills to review and analyze scientific journal articlesAssist with generation and/or review of study-related abstracts, posters, presentations, manuscripts as neededDesired Profile:
Bachelor's Degree (science preferred as well as Masters)Ability to travel 20 - 30% (US and international travel required)Previous clinical research experience (minimum 5 years) and clinical study management (minimum 2 years) requiredInternational clinical experience preferredPrevious collaboration with physician investigatorsStrong knowledge of clinical research study design and study monitoring functionsUnderstanding of GCP and 21 CFR 812Experience working with Institutional Review Boards and/or Ethics CommitteesStrong technical writing skills
Your role with the company:
Responsible for managing clinical studies in accordance with internal standard operating procedures and applicable regulations and guidelinesCollaborate with internal and external clinical team members and consultants to draft clinical study protocols, Instructions for Use, Report of Prior Investigations, Investigational Brochures and other clinical study documentationOversee clinical site selection and activationManage study safety by tracking and reporting adverse events as required by regulatory bodies, reviewing adverse event trends, and overseeing safety committees including Clinical Events Committees and Data Safety Monitoring BoardsOversee monitoring activities related to assigned clinical studies including review and approval of monitoring plan and monitoring reports, managing monitoring schedule and ensuring corrective action related to monitoring findingsDevelop training plans for study training and review/approve training documentationPrepare study-related reports including annual, interim and final study reportsOrganize and lead study-related conference calls and Investigator meetings as needed through the studyOversee investigational device allocation, distribution and reconciliationCollaborate with data management team to ensure appropriate data capture and query managementAssist with and/or perform data analysisUse critical thinking skills to review and analyze scientific journal articlesAssist with generation and/or review of study-related abstracts, posters, presentations, manuscripts as neededDesired Profile:
Bachelor's Degree (science preferred as well as Masters)Ability to travel 20 - 30% (US and international travel required)Previous clinical research experience (minimum 5 years) and clinical study management (minimum 2 years) requiredInternational clinical experience preferredPrevious collaboration with physician investigatorsStrong knowledge of clinical research study design and study monitoring functionsUnderstanding of GCP and 21 CFR 812Experience working with Institutional Review Boards and/or Ethics CommitteesStrong technical writing skills