Senior Clinical Project Manager
<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p>
<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p>
<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Qualified candidates will have 8+ years of clinical trial 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. </span></p>
<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">This is a permanent remote opportunity, in Romania. Please note that you must have CRO experience to be considered. </span></p>
<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Join our global team and help improve peoples' lives! </span></p>
<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"> <strong>Main Job Tasks and Responsibilities: </strong></span></p>
<ul>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Manage and coordinate the assigned clinical projects.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.).</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Keep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Knowledgeable in the application process for clinical studies, in force in the country/ies of work.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.).</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">May act as a Technical Specialist supervising the projects within specific therapeutic and technical areas.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Assure the proper timelines of the assigned projects.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Manage the budget for the project.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Monitor the workload and the performance of the project team.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Plan and monitor the tasks of the team in the specific areas.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Coordinate the Clinical Research Associates and Clinical Monitors activity.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Collaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activities.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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.).</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Collaborate with the CTAs in archiving activities.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Assist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study Reports.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Deliver project specific trainings.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Organize and participate in Monitor and Investigator Meetings.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Organize or take part in the periodic project update meetings.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Provide project updates to the Sponsor, Senior Project Manager and Project Director/Leader as required.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Inform the Project Director/Leader about any issues.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Perform co-monitoring visits for the assigned clinical projects as necessary.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Act as a tutor for Project Coordinators and Project Manager I.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Maintain relationships with the Sponsor, including providing project updates.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Prepare the SOPs relating to clinical research activities in collaboration with the Quality System Unit.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Collaborate in complying and enforcing Company procedures.</span></li>
</ul>
<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Education, Experience and Skills:</strong></span></p>
<ul>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Eight (8) years (at least) of clinical research experience in Project Management.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Previous experience managing respiratory, rare disease, general medicines and/or GPL1 studies is required. </span></li>
<li style="font-family: t
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