Medical Manager

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. Key Accountabilities: Project Execution: Medical Monitoring Delivery & PV Support Deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e., tasks and time per task contracted) and according to the assigned role (generally Regional Lead Physician or Medical Monitor support role). - Participate actively in study planning with feasibility leaders, solution consultants, and other medical representatives. - Participate in team project and investigator meetings. - Provide training of study teams on TA indication and protocol (Note that this does not include any direct medical advice on patient care or management) - Communicate with relevant sponsor counterparts on challenges and accomplishments related to assigned project/study. - Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans - (MMP), Medical Data Review Plan (MDRP) design and implementation, integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc. in conjunction with clients / sponsors or in conjunction with other Parexel departments. Deliver medical monitoring activities according to MMP during the study conduct: - Answer to site/ study team questions relating to the study conduct or protocol. - Review and sign off all data listings / tables, protocol deviations, datasets, for medical accuracy/consistency in accordance with study plans (Medical Monitoring Plan, Medical Data Review Plan, Data Surveillance Plan etc.) Deliver medical support to the project in close coordination with the Medical Monitor / Global Lead Physician, and according to the role assigned by: - Timely identifying risks and challenges, - Pro-actively proposing and/or delivering relevant actions contributing to the success of the study/project and risk mitigation. - Creating a sense of urgency on any matters pertaining to safety of study participants and scientific integrity of the study. - Attend and support any audits or inspections pertaining to assigned studies even if not directly involved in the audited activities. - Participate in periodic rotas including night and weekend shifts e.g. for emergency medical contact and emergency unblinding phone requests for Parexel studies, as applicable and/or appropriate for the MD. - Provide medical input into PV workflows and projects and participate in safety processing for studies including medical review of serious adverse events. - Function as pharmacovigilance representative/safety scientist - Support regulatory safety reporting activities. - Work as Subject Matter Expert (SME) - Provide input for process improvements. - Work closely with Project Lead/Functional Lead for process coordination and to ensure meeting all Key Performance Indicators (KPIs) for the process. Client Relationship Building & Engagement - Actively listen to, solicit, and address client feedback and suggestions regarding medical study-related activities to enhance client satisfaction. - Follow up satisfaction metrics pertaining to medical activities in assigned studies and propose / execute remediation plan in coordination with line manager and Project Leader in case of client dissatisfaction. Business Development - Support Business Development, as agreed with line manager, while adequately balancing time devoted to this activity with bi