Senior Clinical Project Manager

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About the role

ClinChoice is a global full-service CRO recognized for its commitment to professional development, strong work-life balance, and a collaborative, quality-driven “one-team” culture. We are currently seeking a Senior Clinical Project Manager to support projects across pharmaceutical, biotechnology, medical device, and consumer health clients, ranging from emerging companies to large global organizations. In this role, you will lead cross-functional teams and oversee the execution of complex clinical trials, ensuring successful delivery in accordance with contractual commitments, SOPs, ICH-GCP guidelines, and applicable regulatory requirements. Qualified candidates will have 8+ years of clinical project management experience, including prior experience within a CRO environment. Experience managing complex studies (such as respiratory or rare disease) and/or general medicine studies is required. This is a permanent remote opportunity, in Romania. Please note that you must have CRO experience to be considered. Join our global team and help improve peoples' lives! Main Job Tasks and Responsibilities: • Manage and coordinate complex clinical projects. • Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.). • Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members. • Keep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned. • Knowledgeable in the application process for clinical studies, in force in the country/ies of work. • Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.). • May act as a Technical Specialist supervising the projects within specific therapeutic and technical areas. • Assure the proper timelines of the assigned projects. • Manage the budget for the project. • Monitor the workload and the performance of the project team. • Plan and monitor the tasks of the team in the specific areas. • Coordinate the Clinical Research Associates and Clinical Monitors activity. • Collaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activities. • Collaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.). • Collaborate with the CTAs in archiving activities. • Assist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study Reports. • Deliver project specific trainings. • Organize and participate in Monitor and Investigator Meetings. • Organize or take part in the periodic project update meetings. • Provide project updates to the Sponsor, Senior Project Manager and Project Director/Leader as required. • Inform the Project Director/Leader about any issues. • Perform co-monitoring visits for the assigned clinical projects as necessary. • Act as a tutor for Project Coordinators and Project Manager I. • Maintain relationships with the Sponsor, including providing project updates. • Prepare the SOPs relating to clinical research activities in collaboration with the Quality System Unit. • Collaborate in complying and enforcing Company procedures. Education, Experience and Skills: • Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; Nursing degree or relevant degree or background preferred. In some cases, an equivalency, consisting of a combination of appropriate education, tra

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