Clinical Data Manager

Are you passionate about precision medicine and advancing the healthcare industry? Recently, advancements in the underlying technology have finally made it a reality for AI to significantly impact clinical care. Tempus' proprietary platform connects an entire ecosystem of real-world evidence, delivering real-time, actionable insights to physicians. This ensures the provision of crucial information concerning correct treatments for the right patients, at the right time. The Clinical Data Manager will be contributing to and leading data management activities that support client studies throughout all clinical drug development stages. They will be responsible for collaborating with cross-functional teams as they lead data management initiatives for Tempus Compass. The ideal candidate is experienced in international CRO settings, understands data management best practices, good clinical practice, and all relevant regulatory requirements. It's crucial that this candidate has direct experience in developing a data management department and has broad experience with all clinical trial phases, with a strong focus on oncology and phase 1 experience. Job responsibilities include: - Contributing to data management activities that support clinical studies, such as eCRF development, database build, data collection monitoring, and oversight of database lock activities. - Collaborating with internal and external parties. - Establishing cross-functional internal data review plans, coordinating data cuts/transfers, and conducting data reviews. - Reviewing CRO data management plans and other study documentation. - Representing data management at internal meetings and meetings with external vendors. - Participating in drafting/review of timelines in accordance with company goals, ensuring all deliverables and milestones are met. - Reviewing clinical protocols/amendments, clinical study reports, statistical analysis plans, etc. - Supporting GCP inspection readiness. - Aligning with company core values. - Completing any other assigned duties and possibly traveling. Minimum qualifications: - BS/BA in a scientific discipline, with a preference for an MS or equivalent, and at least 7 years of related experience in a CRO/pharmaceutical/biologics/biotechnology company. - Study/Vendor oversight experience. - Expertise in Data Management processes. - Understanding of regulations and industry-adopted data standards. - Experience with EDC data management systems. - Knowledge of ICH GCP and industry practices and standards. - Proficient in Microsoft Word and Excel. Preferred qualifications: - Experience with global studies and use of an outsourced CRO model. - Experience with Medidata Rave EDC. - Experience using standardized medical terminology, including MedDRA and WHODrug. Personal skills: - Excellent interpersonal and communications skills, problem-solving and organization skills. - Ability to work independently and manage others. - Terrific organizational skills. - Excellent analytical and problem-solving skills. - Excellent communication skills with a diplomatic approach. - Ability to independently minimize and mitigate risk. - Ability to conduct root cause analysis in business problem solving. - Excellent presentation skills. About Tempus Compass: We strive to distinguish ourselves through our unique culture which was very intentionally created with great care and effort. Our core belief is that success is about bringing great people together to deliver exceptional outcomes. When this approach is taken, we become a more adaptable, collaborative, inventive, inspirational, and successful organization. We also happen to have a lot of fun! We advocate questioning the norm and seeking alternatives, and we appreciate team members who are driven by curiosity and understand the power of collective thinking. We encourage ongoing learning and constructive feedback. We aim to build and maintain trust, both internally and externally. We offer a supportive, inclusive culture, where every team member is encouraged to speak up, ask questions, offer solutions, and actively contribute to the overall success of the company and our clients. We trust our team members to uphold the highest standards in their personal actions and relationships and hold each other accountable. #LI-SH1 #LI-Remote We are an equal opportunity employer. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.