Clinical Site Lead, Pharmaceuticals, Cardiovascular
Clinical Site Lead, Pharmaceuticals, Cardiovascular Clinical Site Lead, Pharmaceuticals, Cardiovascular Get AI-powered advice on this job and more exclusive features.Our client, a Fortune 500 Medical Device company, has engaged GForce Life Sciences to source a skilled Clinical Site Lead (CSL). The CSL will oversee clinical study site maintenance, data collection, and field monitoring to ensure compliance with protocols, regulations, and Good Clinical Practices. Responsibilities include managing essential documents, resolving data discrepancies, reviewing adverse events, and coordinating site initiation. The role requires analytical problem-solving, process optimization, and continuous quality improvement. The CSL will monitor site performance, identify areas for improvement, and provide solutions to management.Job DutiesMonitors clinical studies at sites in an assigned territory (and others as requested) to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits.Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects. This may include, but is not limited to:Reviewing data and source documentation from investigational sites for accuracy and completenessEnsuring adverse events and protocol deviations are reported in an efficient mannerEnsuring that device complaints and malfunctions are reportedResolving and/or facilitating resolution of problems including identification of cause and actions to prevent reoccurrenceCoordinates with study teams, field clinical engineers or designee and specialists to:Enroll sites into new and ongoing clinical studiesFacilitate enrollment of study subjects via site coordinatorsFacilitate resolution of data queries and action items at clinical sitesPromptly reports the findings of monitoring visitsCollaborates with in-house teams to ensure complete submission of study documents.Trains site personnel to ensure compliance with the study protocol and local regulations.RequirementsBachelor's Degree - Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field.10+ years of clinical trial monitoring experience required.Familiarity with cardiac, vascular, and/or neuromodulation technologies.Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment.Term & StartRemote/home-based; Must be located in Illinois, North Dakota, South Dakota, Minnesota, Iowa, Nebraska, Wisonsin, Kansas, or Missouri50-75% travel (depending on clinical trials)25-30+hrs/weekSeniority level Seniority level Mid-Senior levelEmployment type Employment type ContractJob function Job function Science, Research, and Product ManagementIndustries Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical ManufacturingReferrals increase your chances of interviewing at GForce Life Sciences by 2xInferred from the description for this job Medical insuranceVision insurance401(k)Get notified when a new job is posted.Sign in to set job alerts for "Clinical Specialist" roles. Clinical Research Associate (CRA) - All Levels Clinical Care Coordinator (Remote) – Text-Based APCM Program Clinical Review Specialist - EDS (Day Shift & Fully Remote) Clinical Care Coordinator (Remote) – Text-Based APCM Program New York, United States $67,000.00-$106,000.00 6 days agoChicago, IL $55,000.00-$60,000.00 1 month agoClinical Quality Improvement Coordinator - Remote Remote - Senior Clinical Trial Specialist Clinical Support Specialist (Temp-to-Hire) San Francisco, CA $17.00-$22.00 5 months agoLearning and Development Specialist, Clinical United States $85,000.00-$100,000.00 1 week agoUnited States $115,200.00-$172,800.00 5 days agoClinical Quality Improvement Coordinator - Remote Clinical Quality Improvement Coordinator - Remote Mental Health Clinical Wellbeing Specialist - Remote United States $105,000.00-$110,000.00 3 days agoWe're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.#J-18808-Ljbffr