Director Clinical Research

We are seeking a strategic and results-driven Director, Clinical Research to lead and manage clinical research programs from design through execution. This role is responsible for overseeing clinical studies, guiding cross-functional teams, and ensuring all research activities are conducted in compliance with regulatory standards and timelines. This leader will serve as a key partner to internal stakeholders, CROs, investigators, and vendors, ensuring high-quality execution and delivery of clinical programs. Key ResponsibilitiesLead and oversee clinical research programs and multiple clinical studiesAuthor and finalize study protocols for interventional, non-interventional, and retrospective studiesIdentify, select, and qualify investigational sitesManage and supervise CROs, vendors, consultants, and clinical study staffEnsure compliance with ICH/GCP guidelines and applicable regulatory requirementsConduct or oversee site visits and monitoring activities as neededReview informed consent forms and maintain accurate Study Master File (TMF) documentationPlan, coordinate, and lead investigator meetings and site training sessionsOversee safety reporting processes, including adverse event training and SUSAR submissionsManage clinical data flow, including query resolution and CRF trackingCoordinate clinical supply logistics, including shipment, accountability, and returnsTrack patient enrollment and proactively resolve site or study issuesMaintain and update Clinical Trial Management Systems (CTMS)Ensure proper documentation and filing in relevant systems (e.g., TMF, Expresso)Oversee study budgets, vendor payments, and investigator paymentsReview and approve vendor invoices and associated documentationCommunicate critical study or personnel issues to senior leadershipContribute to the development, review, and training of clinical SOPs EducationB.S./B.A. degree preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) Professional Experience, Knowledge & Technical Skills10+ years Clinical Research/Management experience with demonstrated experience in multinational and/or multi-site clinical studies. Knowledge of GCPs, CFR, ICH and EU guidelinesStrong organizational, communication and teamwork skills. Ability to manage several projects simultaneously. Experience in diagnostic imaging field is desired.Ability to manage multiple projects/programs simultaneouslyAbility to manage investigators, consultants, vendorsExcellent written and verbal communication skills with particular attention to communicating study informationTaking personal responsibility to achieve results/objectives and makes every effort to achieve the expected outcome of any taskAbility to work independently, with minimum supervisionAbility to work in a teamAbility to deal with competing priorities, meet aggressive timelines within the assigned scope of the project Core RelationshipsMedical Planning and ManagementMedical Affairs and Scientific InformationData ManagementBiostatisticsRegulatory Affairs &Medical WritingCorporate Drug SafetyManagement OfficeCorporate Quality ManagementClinical Research Quality SystemsGlobal Legal Affairs