Sr Project Manager, Clinical (Remote)

Job DescriptionResponsible for leading and managing a team of field Clinical Research Associates (CRAs) (monitors) and in-house CRAs to ensure the successful execution of clinical trials in compliance with regulatory requirements, Good Clinical Practice (GCP), and company standards. Oversee CRA performance, provide strategic guidance, and ensure operational excellence across all phases of clinical research.Leadership & Team ManagementRecruit, train, mentor, and develop field and in-house CRAs to maintain a high-performing teamConduct regular performance evaluations and provide coaching for career developmentFoster a culture of collaboration, accountability, and continuous improvementClinical Trial OversightEnsure sites are monitored according to protocol, SOPs, and regulatory guidelinesReview monitoring reports and ensure timely resolution of site issuesOversee site selection, initiation, monitoring, and close-out activitiesOperational ExcellenceDevelop and manage CRA resource plans to meet project timelines and budgetsCollaborate with cross-functional teams (e.g., Clinical Operations, Data Management, Safety, etc.) to ensure seamless trial executionIdentify and mitigate risks impacting study deliverMetrics & ReportingTrack and report CRA performance metrics and study progress to senior leadershipProvide input into departmental strategy and process improvementsCompliance & Quality AssuranceEnsure adherence to GCP, ICH guidelines, and applicable regulatory requirementsImplement quality control measures to maintain data integrity and patient safetySupport audit and inspection readiness across all assigned studiesComply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organizationPerform additional duties as assignedLocation MVAliso Viejo, California, USA Department Name652-Clinical Admin-Pre Market Operations QualificationsBachelor’s degree in Life Sciences or related fieldMinimum of eight (8) years of direct clinical research experience, including a minimum of four (4) years of experience supporting neurovascular clinical trials in the medical device industryMinimum two (2) years of personnel management experience in the medical device industryDemonstrated ability to lead teams in a matrix environmentIn-depth understanding of clinical study management, terminology, and related GCP and regulatory requirementsProven experience with audits and regulatory inspectionsProficiency with basic study design and logistical elements such as protocol development, site selection, budget development, IRB submission preparation, training, database/CRF development, contracts, informed consent, randomization, monitoring, statistical plans, and the tracking of study metricsStrong verbal and written communication skillsProficiency in the use of MS Office products including Word, Excel, PowerPoint, Outlook, Teams, etc.Proficiency in various clinical research eSystems including Meritive, Veeva, iMedNet, and othersDesired QualificationsMaster’s degree in Business or Life Sciences, or equivalent combination of education, training, and experienceExperience in implementing clinical trials and interpreting trial results, including an understanding of data and data analysisMinimum five (5) years of monitoring experience, preferably in the medical device industryIDE clinical experience strongly preferred, including experience in conducting global studiesAn understanding of worldwide regulations governing the conduct of clinical studiesAbility to handle multiple tasks efficiently and consistently, meeting deadlinesDetail-orientedAbility to maintain strict confidentialityEEOWe are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.Fair Chance OrdinanceIf you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.External-Facing TitleSr Project Manager, Clinical (Remote)Posting CountryUS - United States Salary Range$140,507-$175,633 Financial compensation packages may be higher/lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.

Apply Now