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And I do it Search Jobs Search Jobs Keyword: Location: Radius: Enter distance 5 15 25 35 50 Unit MILES KM Search Jobs View Remote Jobs View All Jobs View remote jobs View all jobs Country Study Manager - FSP - East Coast Primary Location: United States, Remote Job ID R0000046288 Category Clinical Trials Apply Now Save Job About this Role Job Summary: The Country Study 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 activities Manage 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 flow Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specific studies Provide input into global subject/patient recruitment plans Manage 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 oversight Create and update critical trial-specific documents Support development of compound and protocol level training materials Review and provide input into budgets, timelines, and forecasts for assigned clinical studies Provide support for inspection readiness activities including risk identification and mitigation plans at the trial level Participate in process improvement activities at a trial and department level as needed Manage relationships between study sites and vendors Interface with internal key stakeholders Support onboarding of new team members Attend stakeholder meetings and provide input and updates on operational activities and progress Skills: Excellent decision-making, analytical, and financial management skills Excellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision Experience in leading without authority and in multifunctional matrixed and global environments Experience mentoring and coaching others Exceptional organizational skills and ability to deal with competing priorities Strong reasoning and problem-solving abilities Strong project planning/management, communications (written and verbal) and presentation skills Experience with protocol, informed consent form (ICF), case report form (CRF), and clinical study report (CSR) development and review Proficient 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 trials 2-3 years leading aspects of global clinical trials Experience working with CROs Education: Bachelor's degree is required #LI-CF1 #LI-REMOTE 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 Save Job Share this Page X Facebook LinkedIn Email Careers in Neuroscience Neuroscience diseases affect the very core of one’s being and experience. We work diligently to lighten the burden for patients and families alike. Explore opportunities to join our team. Learn more Careers in Inflammation & Immunology Each day, we’re working toward building a deeper connection and understanding with those who count on us – the patients. Learn more Careers in Cell and Gene Cell and gene therapies (CAGT) have rapidly emerged as among the fastest-growing spaces in all of biopharma R&D, and Parexel was an early entrant into this space. 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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 Events Events Learn more Learn more Aida Sabo, Sr. VP Global Inclusion at Parexel Discover how Aida drives inclusion at Parexel, which strategy has been successful and the why behind it. Learn more Follow us on Social Media Parexel is present on several social media channels where we post our latest updates. Follow, interact, and rate us! Learn more Medical Writing at Parexel Join a global team of 700+ medical writers transforming complex scientific data into clear communications that advance therapies and improve patient care. Learn more A day in a life of a Project Leader Christine and Ewa share what a Project Leader does, why to become a Project Leader, and what mindset is needed. Explore how a Project Leader resembles a cheerleader or a coxswain of a rowing boat! 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Learn more Meet Santino: Senior Clinical Operations Leader Santino's career at Parexel, from a Project Specialist to a Sr. Clinical Operations Leader, showcases a diverse journey through Clinical Operations, fueled by a passion for the pharmaceutical industry and a commitment to impacting patient lives. His experience highlights Parexel's dedication to professional growth and the embodiment of the "We Care" promise in every facet of their work. Learn more Meet Siddhika: Clinical Data Analyst III Meet Siddhika, Clinical Data Analyst III as she explains why she decided to apply to Parexel after a six year career break Learn more Meet Jitender: Director, Health Economics Jitender describes his role as a Director, Health Economics, supporting our clients with strategic recommendations and delivering the value story of new treatments. 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Learn more Meet Na Young: VP & APAC Head of Enterprise Account Leadership Na Young participated in our Women in Leadership program and an MBA program and believes the advice from Parexel colleagues to BE BOLD encouraged her to take the risk to move forward. Learn more Meet Chalermporn: Senior Clinical Research Associate Chalermporn talks about what it is like to be a CRA at Parexel, and the support she has been given to pursue her career. Learn more Meet Dorothy: Senior Document Quality Reviewer Dorothy shares her story about returning to work after a career break, and how she arrived at Parexel, having previously worked for another CRO. Dorothy even draws comparisons between Parexel and Hogwarts. Dorothy re-excelled at Parexel! 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 Watch Replay: Online Seminar Italy Clinical Research Associates Putting the Patients First View this career seminar to hear from our Clinical Operations colleagues and Clinical Research Associates about the role of a CRA and working in Clinical Operations at Parexel. Learn more Watch Replay: Online Seminar UK Clinical Research Associates Putting the Patient First View this webinar to hear from our Clinical Operations colleagues and Clinical Research Associates about the role of a CRA working in Clinical Operations at Parexel Learn more Watch Replay: Online Seminar EMEA Your Skill Set Could Save Lives Working as a Stats Programmer View this webinar to hear from our Data Operations colleagues and about the role of Statistical Programming in the Clinical Research Industry Learn more Location: Quakertown Depot Come work with a supportive team of 30 colleagues in Quakertown to provide packaging, labeling, and global distribution of clinical trial materials. 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Learn more Meet Swarnalatha: Senior Principal Statistical Programmer FSP Swarnalatha has been working for over 14 years in the pharma industry as a Statistical Programmer, and has been impressed with the work flexibility and empowerment of female colleagues at Parexel. Learn more Meet Angeli: Senior Project Specialist Angeli shares what it is like to work as a Project Specialist and with her colleagues within the Project Planning & Support department. Learn more Meet Agnieszka: Senior Clinical Operations Leader Agnieszka shares about her role as a Senior Clinical Operations Leader, the skills needed, the challenges and teamwork. She is looking back on a 17-year career path at Parexel. Learn more Job Summary: The Country Study 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 activities Manage 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 flow Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specific studies Provide input into global subject/patient recruitment plans Manage 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 oversight Create and update critical trial-specific documents Support development of compound and protocol level training materials Review and provide input into budgets, timelines, and forecasts for assigned clinical studies Provide support for inspection readiness activities including risk identification and mitigation plans at the trial level Participate in process improvement activities at a trial and department level as needed Manage relationships between study sites and vendors Interface with internal key stakeholders Support onboarding of new team members Attend stakeholder meetings and provide input and updates on operational activities and progress Skills: Excellent decision-making, analytical, and financial management skills Excellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision Experience in leading without authority and in multifunctional matrixed and global environments Experience mentoring and coaching others Exceptional organizational skills and ability to deal with competing priorities Strong reasoning and problem-solving abilities Strong project planning/management, communications (written and verbal) and presentation skills Experience with protocol, informed consent form (ICF), case report form (CRF), and clinical study report (CSR) development and review Proficient 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 trials 2-3 years leading aspects of global clinical trials Experience working with CROs Education: Bachelor's degree is required #LI-CF1 #LI-REMOTE
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