• Provide clinical expertise and scientific insights to help monitor, track, and analyze subjects’ data in phase 1 - 3 studies • Collaborate with the Medical Lead and groups involved in Clinical Development such as Pharmacokinetics, Clinical operations, Biometrics, Pharmacovigilance, and Medical Affairs • Monitor, analyze, and review safety and efficacy data for events of interest • Review laboratory parameters, patient profiles, data listings, summary tables • Collaborate with clinical leads and medical directors on scientific content and program strategy • Support authoring and review of various clinical and regulatory documents • Address scientific and protocol related issues from investigators • Contribute to safety narratives, manuscripts, and scientific presentations • Support preparation for safety review committees • Review protocol deviations to identify cause and resolution • Participate in Database lock activities and represent CR at internal meetings • Contribute to the development of regulatory documents in collaboration with Medical Affairs and Patient Advocacy • Participate in research site identification and relationship building with CROs