[Remote] Clinical Research Leader

Note: The job is a remote job and is open to candidates in USA. Vita Global Sciences, a Kelly Company, is seeking a Clinical Research Leader to manage and support clinical trials within the Clinical R&D Department. This role involves ensuring compliance with study milestones and fostering relationships across the organization.ResponsibilitiesServe as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestonesOversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating ProceduresMay serve as the primary contact for clinical trial sites (e.g. site management)Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal supervisionEnsure applicable trial registration from study initiation through posting of results and support publications as needed; (e.g. on www.clinicaltrials.gov)Management/oversight of ordering, tracking, and accountability of investigational products and trial materialsInterface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnelOversee the development and execution of Investigator agreements and trial paymentsResponsible for clinical data review to prepare data for statistical analyses and publicationsIf applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study needMay contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projectsIf applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the centerContribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generatedResponsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs)Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholdersTrack and manage assigned project budgets to ensure adherence to business plansSupport clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategyDevelop a strong understanding of the pipeline, product portfolio and business needsMay serve as the clinical representative on a New Product Development teamMay be responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and ReportsMay conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messagingResponsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and proceduresManage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiencyPerform other duties assigned as neededGenerally manages work with limited supervision, dependent on project complexity Independent decision-making for simple and more advanced situations but require minimal guidance for complex situationsSkillsMinimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science requiredPrevious experience in clinical research or equivalent is requiredExperience working well with cross-functional teams is requiredGood understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulationsAbility to provide scientifically strategic and scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projectsProven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulationsStrong presentation and technical writing skillsRelevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)Clinical/medical background a plusExperience managing projects a plusMedical device experience highly preferredCompany OverviewFrom Research To Reality. It was founded in 2014, and is headquartered in Waltham, Massachusetts, USA, with a workforce of 51-200 employees. Its website is https://vitadatasciences.com.