Clinical Trial Manager - FSP

My research opens up new medical possibilities. And I do it Search Jobs Search Jobs Keyword Matching job links will appear below as you type. Location: When autocomplete results are available use up and down arrows to review and enter to select. Touch device users, explore by touch or with swipe gestures. Radius: Enter distance 5 15 25 35 50 Unit MILES KM View Remote Jobs View All Jobs View remote jobs View all jobs Clinical Trial Manager - FSP Primary Location: United States, Remote Job ID R0000046288 Category Clinical Trials Apply Now About This Role Job Summary: The Clinical Trial Manager is responsible for the execution of study-level activities including but not limited to creating and updating trial-specific documents, vendor oversight & delivery, compound training and country and regional oversight of CRO operational delivery. This includes alignment on the feasibility strategy, target setting, risk reviews, and country challenges that could impact overall study delivery. Key Accountabilities Manage integration of project team activitiesManage strategic study operations including but not limited to study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, budget and financial information, performance metrics, and data flowProvide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specific studiesProvide input into global subject/patient recruitment plansManage aspects of CRO/vendor identification and the day-to-day operational management activities of CROs and other vendors including set up, statement of work creation, and budget oversightCreate and update critical trial-specific documentsSupport development of compound and protocol level training materialsReview and provide input into budgets, timelines, and forecasts for assigned clinical studiesProvide support for inspection readiness activities including risk identification and mitigation plans at the trial levelParticipate in process improvement activities at a trial and department level as neededManage relationships between study sites and vendorsInterface with internal key stakeholdersSupport onboarding of new team membersAttend stakeholder meetings and provide input and updates on operational activities and progress Skills Excellent decision-making, analytical, and financial management skillsExcellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervisionExperience in leading without authority and in multifunctional matrixed and global environmentsExperience mentoring and coaching othersExceptional organizational skills and ability to deal with competing prioritiesStrong reasoning and problem-solving abilitiesStrong project planning/management, communications (written and verbal) and presentation skillsExperience with protocol, informed consent form (ICF), case report form (CRF), and clinical study report (CSR) development and reviewProficient in MS Office Suite (Excel, Word, and PowerPoint)Ability to travel approximately 10% Knowledge And Experience Minimum 5+ years of clinical research experience gained with a CRO, biotech or pharmaceutical company working on phase I-IV global clinical trials2-3 years leading aspects of global clinical trialsExperience working with CROs Education Bachelor's degree is required EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Apply Now Share this Page XFacebookLinkedInEmailWorking as a Nurse in Clinical Research at Parexel Antje and Katharina share insights into working as a Nurse in Clinical Research, where innovative medications are developed through early-phase and first-in-human studies. Learn more Meet Hina, an Executive Director championing excellence and empathy Parexel's Hina Saleem, Executive Director, Clinical Operations, shares how empathy and excellence drive her approach to clinical trial optimization and authentic leadership. Learn more Meet Margaret: Clinical Research Nurse Find out why Margaret enjoys working as a Nurse in Clinical Research and working at Parexel, also how Parexel supports her in a way she hasn't experienced anywhere else. Learn more Video on Working With Heart® - Christina's Clinical Operations Manager Perspective View how Christina reflects on her work experience, her impact on patients and her management style of respect and growth. Christina is leading a team of Clinical Operations Leaders who manage groundbreaking trials in the biotech space. Learn more Meet Alexis, a Clinical Research Associate II championing patient care Alexis progressed from Administrative Assistant to CRA via Parexel's APEX program. She passionately works for the patients, sites and coworkers to make a difference. Off-duty, she enjoys time with her poodle, Millie, and baking shows. Learn more Meet Adriane, a Senior Clinical Operations Leader sharing insights and tips Discover Adriane's role as a Clinical Operations Leader. She shares insights into her daily responsibilities, the skills crucial for success, and the rewarding challenges she faces. Learn how Parexel supported her career development and gain inspiration from her advice on professional growth. Learn more Optimizing the clinical research workforce: An industry analysis by Parexel This comprehensive report benchmarks the trends and innovations having the greatest impact on drug development and identifies the skills required for today’s workforce. Learn more Meet David, a champion for disability inclusion His leadership fosters workplace and clinical research inclusivity. Explore David's inspiring journey from combat medic to Parexel VP and Disability Inclusion Business Resource Group co-lead. Learn more Meet iCRA Twins Marina Palumbo and Anna Korelis Double the passion and double the commitment to working With Heart™. Read on to learn more about these colleagues whose family and work lives are uniquely intertwined at Parexel! Learn more Clinical Operations Opportunities Are you passionate about making a difference in the fight against cancer and beyond? At Parexel's Global Clinical Operations, we are dedicated to putting patients at the heart of every clinical trial. With a global footprint and 5000 Clinical Operations team members worldwide, we are impacting clinical research. Learn more Meet Stacy Hurt, Chief Patient Officer at Parexel Insights on Parexel's patient-centric approach, innovative strategies, and authentic culture in clinical research. Learn how Stacy's unique experiences shape the future of clinical trials. Learn more Meet Andrea: Senior Initiation Clinical Research Associate Andrea's story shows how teamwork, attention to detail and patient focus drive success at Parexel while finding fulfillment in helping innovative treatments reach patients faster. Learn more Meet Julie, a Senior Clinical Assistant, proud of her contribution Julie welcomes volunteers at the Early Phase Clinic reception in Berlin, manages payments, and caters to the volunteers in the kitchen. Learn more Meet Laurias: Manager, Clinical Operations Laurias shares how Parexel has supported his career development from CRA to Clin Ops Manager and flexibility within the workplace. Learn more Our work culture Learn about our culture, perks, learning opportunities, and our corporate responsibility approach. Parexel's compassionate and results-driven work culture prioritizes patient care and employee growth. Learn more New Medicines, Novel Insights Newsletter Parexel's insight-generation engine, our people, share perspectives on patient-guided clinical research. Learn more Working where it works for you Parexel offers a flexible approach to work that meets your personal needs while maintaining quality delivery for patients. Choose the right work arrangement for you - in-office, home-based or a mix. Learn more Parexel’s hiring process It’s all about finding the right fit, for you and for us. Our recruiters work with you and our hiring managers to bring together a team and culture where everyone can grow and be successful. Learn more Benefits & Support At Parexel, we prioritize putting people first, allowing you to achieve your best work. Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture. Learn more Inclusion at Parexel Learn how Parexel celebrates the differences our workforce and patients bring and ensures an inclusive environment. Learn more JOBS FOR YOU Senior Clinical Trial Manager - FSP United States of America, RemoteRegulatory Affairs Consultant - CMC Biologics / Plasma Products United States of America, RemoteClinical Trial Manager - FSP United States of America, Remote View All Jobs There is no jobs to view You currently have no saved jobs to view. Make sure to accept the Functional cookies to enable this module to display saved job links. You will be able to review them here when you revisit this page.. View Open Positions More Than A Job Benefits Benefits vary by country, but Parexel is passionate about our team’s overall wellness. Learn More Career Advancement We believe that investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career. Learn More