PClinical Project Manager II - post-trial access / EAP / rollover studies /ppuUpdated : /u July 22, 2025 /ppuJob ID : /u 25003820 /ppDescription /ppClinical Project Manager II - post-trial access / EAP / rollover studies /ppSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. /ppOur Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. /ppWhether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. /ppDiscover what our 29,000 employees, across 110 countries already know : /ppWORK HERE MATTERS EVERYWHERE /ppbWhy Syneos Health /b /pulliWe are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. /liliWe are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. /liliWe are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. /li /ulpJob Responsibilities /ppbProject Leadership and Delivery : /b /pulliManages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements. /liliActs as a primary liaison between the Company and the Customer to ensure timely study launch,conduct, and closeout according to the Customer’s and the Company’s contractual agreement. /liliLead project team to ensure quality, timelines and budget management. /liliAccountable for the financial performance of each project. /liliCoordinate activities and deliverables of all study conduct partners and proactively identify and manage issues. /liliEnsure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements. /liliAccountable for all project deliverables for each project assigned. Documentation and Reporting : /liliResponsible for quality and completeness of TMF for assigned projects. /liliAccountable for maintenance of study information on a variety of databases and systems. /liliResponsible for study management components of inspection readiness for all aspects of the study conduct. /liliOversight for development and implementation of project plans. /liliPlan, coordinate and present at internal and external meetings. /liliPrepare project management reports for clients and management. /liliDeveloping contingency planning and risk mitigation strategies to ensure successful delivery of study goals. Business Development : /liliDevelops strong relationships with current clients to generate new and / or add-on business for the future. /liliMay participate in bid defense meetings where presented as potential project manager. Management : /liliMay be required to line manage other project management team members and clinical monitoring staff. /li /ulpbQualifications /b /pulliBachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience. /liliClinical research organization (CRO) and relevant therapeutic experience preferred. Strong knowledge of Good Clinical Practice / ICH guidelines and other applicable regulatory requirements /liliStrong organizational skills. /liliStrong ability to manage time and work independently. /liliDirect therapeutic area expertise. /liliAbility to embrace new technologies. /liliExcellent communication, presentation, interpersonal skills, both written and spoken. /liliAbility to travel as necessary (approximately 25%). /li /ulpbGet to know Syneos Health /b /ppOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. /ppNo matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. /ppbAdditional Information /b /ppTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. /ppAt Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your pastexperience doesn’t align perfectly, we encourage you to apply anyway. At times, we take intoconsideration transferrable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities. /ppDiscover what our 29,000 employees already know : work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to : /ppSyneos Health (Nasdaq : SYNH) is a leading integrated biopharmaceutical solutionsorganization built to accelerate customer success. We translate unique clinical,medical affairs and commercial insights into outcomes to address modern marketrealities. Together we share insights, use the latest technologies and applyadvanced business practices to speed our customers’ delivery of importanttherapies to patients. We support a diverse, equitable and inclusive culture. /ppuPhone : /u 919 876 9300 /ppuFax : /u 919 876 9360 /ppbToll-Free : 866 462 7373 /b /ppSyneos Health is an Equal Opportunity Employer. All qualified applicants will receiveconsideration for employment without regard to race, color, age, religion, marital status,ethnicity, national origin, sex, gender, gender identity, sexual orientation, protectedveteran status, disability or any other legally protected status and will not bediscriminated against. If you are an individual with a disability who requires reasonableaccommodation to complete any part of our application process, including the use of thiswebsite, please contact us at : Email : One of our staff members will workwith you to provide alternate means to submit your application. /ppJ-18808-Ljbffr /p #J-18808-Ljbffr