Job Details
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.What You Can ExpectIn consultation and collaboration with the Clinical Project Lead or Clinical Manager, you will be able to oversee and support the conduct of clinical studies including but not limited to: study management tasks of site qualification, contract and budget negotiations, preparation and presentation of committee documentation, study initiation and management including pre-monitoring, remote and on-site monitoring, tracking, organizing, filing and maintaining study related documents, maintaining IRB approvals in accordance with applicable compliance regulations and standards (i.e. GCP, ICH, ISO, FDA and MDR). Excellent communication skills needed to provide excellent customer service to surgeon investigators and coordinators as well as internal Zimmer Biomet divisions.How You'll Create ImpactClinical Study Site ManagementIn consultation and collaboration with the Clinical Project Lead and other in-house personnel Clinical team member will be able to assist with the following activities:Identify and assess suitability of clinical study sites and investigatorsPrepare documentation and present nominations of site/investigator to CRRC for approvalFinalize budget and negotiate study contract with sitesSupport and coordinate with PI on IRB/EC reviewPrepare site subject binders, study visit documents and PowerPoint presentationsResolve site issues and data discrepancies / queries with investigators and site coordinatorsConduct site visits (SQV, IMV, COV) as required per Monitoring Plan to perform source data/document verificationComplete clinical study site visit reportsPrepare and distribute Patient Due Listings as appropriateClinical study product and material accountabilityClose out clinical study sites on completion of the studyWill primarily be responsible for non-regulated clinical studies, but may be introduced to regulated study activities as appropriateHow You'll Create ImpactClinical Project ManagementIn consultation and collaboration with the Clinical Project Lead and other in-house personnel Clinical team member will be able to assist with the following activities:Collaborate with Clinical Strategy team to identify product clinical needsCreate study protocol, study synopsis/summary, CRF and Informed Consents documentsPrepare for CIRC review and approvalEstablish clinical database and CRF discrepancy parameters for each study with close collaboration of the Data Management teamMaintain study requirements for posting to clinicaltrials.govMaintain and update Clinical Trials Management System (CTMS) as neededMaintain completeness of site documents in trial master fileAble to assist in the creation and maintenance of the study annual budgetAble to complete a literature search and international registry review to assess product performanceReview and provide input on Post Market Plan, Post Market Reports and other study reports as necessaryOversee Investigator Initiated Research (IIR) projects as assignedAble to create and edit a study report (annual or ad hoc) as neededAssist other team member participating in the cross-training opportunities with study-related activitiesHow You'll Create ImpactProcess ManagementIn consultation and collaboration with the Clinical Project Lead and other in-house personnel Clinical team member will be able to assist with the following activities:Works with team members to identify process improvementsParticipate in regional and global process improvement initiativesMaintain standard operating proceduresActively participates in departmental and business unit meetings and scheduled activitiesWilling to assist and mentor other team membersAbility to effectively identify and resolve conflicts and disagreements regarding clinical research mattersImpacts project teams and business units through quality work and leadership of projects or portions of projectsKeep current on learning requirements without lapse or overdue assignmentsWhat Makes You Stand OutWorks well as part of a teamPositive attitudeSelf-awareness of the impact of actions on othersWillingness to learn and progressBasic command of English (written and oral) languageUnderstanding and willingness to follow Zimmer Biomet policies, procedures, standard operating procedures, and work instructionsBasic understanding and willingness to comply with Regional and Global regulations (ICH/FDA/MDR)Basic understanding of medical terminologyAbility to prioritize assignments, manage time efficiently and assist in project oversight to meet established deadlinesDevelop competencies with CTMS, Medispend, electronic data capture systems and other electronic systems used for clinical researchProficient in Microsoft Office including Word, Excel, and PowerPointAbility to multi-task in fast paced environment is essential.Must be able to perform in a diverse cross-functional team environmentInitiates and exchanges best practices with other team members and business partnersAble to adapt behaviors and attitude to improve performance of the team and to have a positive effect on the outcome of the projectDevelopment of project management skillsYour BackgroundBachelor's Degree or postgraduate degree or in nursing, life sciences, engineering or medical sciencesClinical research experience (sponsor) or clinical study management (site) (3 5 year)Established knowledge on Good Clinical Practice (GCP) and local government related guidelines / regulationsTravel ExpectationsUp to 35-50%EOE/M/F/Vet/Disability