Medical Monitor/Study Physician/Medical Director - Home Based - FSP

• Provide medical leadership for clinical trials from protocol development through clinical study report completion • Develop and review medical content within Clinical Trial Protocols and contribute to protocol updates as needed • Contribute to risk-based quality management by identifying medically relevant critical data, risks, and mitigation strategies • Provide medical input into Clinical Quality Monitoring Plans, important protocol deviation assessments, and clinical quality activities • Perform ongoing medical review of aggregated clinical trial data, identify risks and quality issues, and support timely mitigation and escalation activities • Contribute medical expertise to key study documents including eCRF design, Data Review Plans, informed consent documents, monitoring manuals, communication plans, training plans, and statistical analysis plans • Support preparation of patient narratives and review medical content of Clinical Trial Reports • Respond to medical questions from investigators, CRO partners, and sponsor representatives while maintaining high standards of medical expertise • Provide medical input into study feasibility, patient recruitment, retention strategies, and site engagement activities • Support interactions with Ethics Committees, Institutional Review Boards, Data Monitoring Committees, Data Safety Monitoring Boards, Steering Committees, and regulatory authorities as applicable • Deliver medical training for investigators, study teams, and sponsor personnel • Contribute to trial communications, newsletters, and scientific publications where applicable

• Specialization in Internal Medicine or General Practice • Clinical development or clinical trials experience • Experience in Medical Monitor, Clinical Trial Leader, Patient Safety Physician, Medical Affairs, Investigator, Sub-Investigator, or Researcher roles • Experience with data visualization platforms and clinical trial technology systems • Experience supporting global clinical trials and multinational development programs

· Medical & Dental Insurance · Life Assurance · Pension • Critical Illness Insurance & Health Screenings We offer a comprehensive benefits package to eligible employees, which includes life assurance, medical and dental insurance, and additional benefit offerings in accordance with the terms of our applicable plans. If this job doesn’t sound like the next step in your career, but perhaps you know of someone who’d be a perfect fit, send them the link to apply! We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. About Parexel Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®. About the Role We are seeking a Study Physician (Medical Monitor, Clinical Development Physician) to join our team in a remote capacity. As a Study Physician, you will provide medical leadership and oversight across the preparation, conduct, and reporting phases of global clinical trials. This role is critical to ensuring patient safety, scientific integrity, regulatory compliance, and high-quality clinical trial execution. As a core member of cross-functional trial teams, you will collaborate closely with clinical development, operations, safety, data management, and medical writing colleagues to deliver medically robust studies that support the advancement of innovative therapies. You will contribute to protocol development, risk-based quality management, clinical data review, study documentation, investigator engagement, and regulatory interactions while helping ensure the highest standards of medical oversight throughout the trial lifecycle. You will join a fast-paced, growth-oriented environment where your medical expertise will directly influence study quality, patient safety, and clinical development outcomes. Working alongside global teams, you will have the opportunity to apply your clinical experience in complex international trials while contributing to research that improves patient lives. Key Responsibilities • Provide medical leadership for clinical trials from protocol development through clinical study report completion • Develop and review medical content within Clinical Trial Protocols and contribute to protocol updates as needed • Contribute to risk-based quality management by identifying medically relevant critical data, risks, and mitigation strategies • Provide medical input into Clinical Quality Monitoring Plans, important protocol deviation assessments, and clinical quality activities • Perform ongoing medical review of aggregated clinical trial data, identify risks and quality issues, and support timely mitigation and escalation activities • Contribute medical expertise to key study documents including eCRF design, Data Review Plans, informed consent documents, monitoring manuals, communication plans, training plans, and statistical analysis plans • Support preparation of patient narratives and review medical content of Clinical Trial Reports • Respond to medical questions from investigators, CRO partners, and sponsor representatives while maintaining high standards of medical expertise • Provide medical input into study feasibility, patient recruitment, retention strategies, and site engagement activities • Support interactions with Ethics Committees, Institutional Review Boards, Data Monitoring Committees, Data Safety Monitoring Boards, Steering Committees, and regulatory authorities as applicable • Deliver medical training for investigators, study teams, and sponsor personnel • Contribute to trial communications, newsletters, and scientific publications where applicable Candidate Profile You’ll thrive in this role if you bring: • Strengths in medical assessment, clinical trial oversight, risk-based quality management, and cross-functional collaboration • Experience working in clinical research, pharmaceutical development, or a regulated healthcare environment • The ability to build relationships across global teams and communicate complex medical information clearly • A patient-focused mindset and commitment to scientific excellence and quality • Comfort working with clinical trial systems, data visualization tools, and digital technologies that support clinical development activities Required Qualifications • Physician (MD), ideally with a medical thesis, trained in a clinical setting • Minimum of 4 years of active clinical practice experience • Understanding of relevant regulations and guidance, including ICH-GCP • Experience within the pharmaceutical industry, CRO environment, pharmacovigilance, project management, clinical development, or another relevant medical function is desirable • Strong communication, analytical, presentation, organizational, and problem-solving skills • Fluency in English, both written and spoken • Ability to work effectively in an international, cross-functional environment and leverage digital technologies to support decision-making and collaboration Preferred Qualifications • Specialization in Internal Medicine or General Practice • Clinical development or clinical trials experience • Experience in Medical Monitor, Clinical Trial Leader, Patient Safety Physician, Medical Affairs, Investigator, Sub-Investigator, or Researcher roles • Experience with data visualization platforms and clinical trial