Clinical Trial Manager

Job Description The Clinical Trial Manager (Germantown Hybrid) serves as the primary client contact and leads all aspects of clinical study execution-from kickoff through CSR completion and regulatory submission. This role ensures seamless project delivery by driving timelines, managing resources and budgets, maintaining compliance, and fostering strong client relationships. Responsibilities • Lead end-to-end project management across all study phases, ensuring objectives, milestones, and quality standards are met. • Oversee study conduct in alignment with FDA regulations, ICH-GCP guidelines, and company SOPs. • Serve as a strategic communicator with clients, senior leadership, cross-functional teams, investigators, and site staff. • Develop and manage project plans, budgets, resources, and risk-mitigation strategies. • Evaluate and manage CROs/vendors to ensure quality, timeline, and budget expectations. • Oversee site start-up, recruitment strategies, study documentation, and investigator meetings. • Oversee monitoring activities including review of monitoring reports for completeness, quality, and adherence to monitoring plans and SOPs. • Review CRFs, monitoring reports, data outputs, and protocol-related materials; support resolution of data queries. • Contribute to protocol development, CRFs, ICFs, operational manuals, CSRs, and regulatory submission components. • Support IND/NDA activities and participate in regulatory interactions, bid defenses, and proposal development. • Conduct co-monitoring or audit visits as needed and assist with continuous improvement of departmental SOPs. #LI-SV1 Qualifications • Bachelor's degree in life sciences or related field with 5+ years of clinical research experience; OR • Master's/advanced degree with 3+ years of clinical research experience. • Clinical research certification (ACRP or SOCRA) preferred. • Strong knowledge of ICH-GCP, FDA regulations, and clinical research operations. • Proven ability to lead cross-functional teams and manage complex timelines. • Excellent communication, organization, and problem-solving skills. • Proficiency in Microsoft Office and willingness to travel. About Us With a legacy spanning more than 80 years, NSF leverages science and innovation to improve human and planet health. We provide science-driven, independent testing, inspection, certification, and advisory services and develop the very standards that drive the food, water, and life sciences industries worldwide. We empower our clients to navigate shifting regulations to improve consumer health, safety, and quality of life. One of our core values is We Are One NSF. This means that while we're one team, we embrace the cultural, ethnic, language, and demographic diversity that reflects the societies in which we live and work. Come join a team that makes a difference in the world. More information about NSF can be found at nsf.org. NSF is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability. Notice to Agency and Search Firm Representatives: Please note that NSF is not accepting unsolicited resumes from agencies/search firms for this role. Resumes submitted to an NSF employee by a third-party agency without a valid written & signed search agreement between NSF and said third-party agency will become the sole property of NSF. No fee will be paid if a candidate is hired as a result of an unsolicited agency or search firm referral. Thank you. About the Team From research to patient, NSF's expert team provides comprehensive regulatory, quality and clinical support to pharmaceutical, biotech, medical devices, in-vitro diagnostics, and combination products clients across the product life cycle to navigate complex regulations and industry challenges.

Created: 2026-03-10