Senior Clinical Project Manager

<p><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 class="isSelectedEnd"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">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 class="isSelectedEnd"><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">Qualified candidates will have 8+ years of clinical trial management experience, including prior experience within a CRO environment. Experience managing complex studies and/or general medicine studies is required. </span></p> <p><span style="font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;">This is a permanent remote opportunity, with the potential for a hybrid work arrangement depending on location. Please note that you must have CRO experience to be considered. </span></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Join our global team and help improve peoples' lives! </span></p> <p><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><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 oncology and respiratory studies is 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;">Previous CRA experience is highly desirable.</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 CRO experience is 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;">Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements</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;">Prior experience in electronic data capture preferred.</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;">Fluent in English.</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;">Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).</span></li> </ul> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>The Application Process</strong></span></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.</span></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Who will you be working for?</strong></span></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>About ClinChoice    </strong></span></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!</span></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Our Company Ethos</strong></span></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.</span></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.</span></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong> Key words:</strong> Senior Project Manager, Senior Clinical Project Manager, Senior Study Manager, Senior Clinical Trial Manager, Study Management, Project Management, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Study Management, Project Leader, Project Lead, complex clinical trials, oncology, respiratory, CRO, Contract Research Organization</span></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">#LI-VH1 #LI-Senior #LI-FULLTIME</span></p>

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