• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. • Demonstrates diligence in protecting the confidentiality of each subject/patient. • Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

Hey Future Daybreak Clinicians! At Daybreak Health, we’re building a world where every young person has access to the mental health support they need to thrive. As a clinician on our team, you’ll be part of a dedicated, compassionate community of therapists who are passionate about making a real impact. We value flexibility, efficiency, and collaboration, allowing you to focus on what matters most—helping students. If you’re looking for meaningful work, a supportive team, and the opportunity to grow, we’d love to have you join us! About the Role: Remote Mental Health Therapist (Georgia) We are looking for associate mental health clinicians to provide teletherapy services to students across Georgia. As a Remote Mental Health Therapist, you will play a key role in delivering high-quality care while collaborating with schools, caregivers, and community partners to ensure student success. We are currently working with the following license types: APC Supervision is FREE to all associates who meet our caseload requirements. What You’ll Do - Provide evidence-based teletherapy to students within our school district partnerships. - Build trusted relationships with students and their families. - Collaborate closely with school counselors and other providers to support student mental health. - Provide psychoeducation and guidance to parents/caregivers. - Participate in case consultations, team discussions, and ongoing training. - Contribute to the development and refinement of Daybreak Health’s clinical programs. Why Join Us? - Receive competitive pay ($35-45/hour) with guaranteed compensation for cancellations and no-shows. - Qualify for FREE Supervision with a Daybreak assigned supervisor under our specialized associate program. - Work remotely with flexible scheduling. - Join a supportive team with ongoing professional development opportunities. - Be part of a mission-driven organization making a difference in students’ lives. What Our Therapists Are Saying... "As we learn, we’re teaching each other. A lot of the interventions that I’ve used are things that I’ve learned from other clinicians. I really love the clinical collaboration which ensures that we provide the best supports for our young clients." "I feel so honored and privileged to work with this group of clinicians. You make me better everyday.” "I absolutely love working with my young clients. They are so real, honest, and....hilarious! They’re the ones inspiring me!” Equal Employment Opportunity At Daybreak Health, we embrace diversity and inclusion and are committed to equity and opportunity for all. We encourage individuals from all backgrounds to apply, including those from diverse communities such as race, ethnicity, gender identity, sexual orientation, ability, age, religion, and socioeconomic background. Pay Range $35—$45 USD

• Lead the EU CMC strategy for multiple clinical programs • Translate technical changes into regulatory robust strategies • Develop solutions for comparability, specifications and process changes • Identify regulatory risks early and define pragmatic mitigation measures • Lead CMC activities for clinical trial applications and amendments • Prepare structured, high-quality submission documentation • Design strategies for communications with regulatory authorities • Prepare for and support interactions with EU authorities • Ensure regulatory compliance of external manufacturing partners • Work closely with Quality and technical functions • Actively monitor regulatory developments in the CMC space • Contribute to the advancement of regulatory standards within the company

Join Us in Elevating Clinical Excellence: Assessment Specialist  At our organization, we believe that meaningful clinical work starts with precision, collaboration, and a deep commitment to quality care. We are building a team of dedicated professionals who value integrity, thoughtful assessment, and doing things the right way. If you bring both clinical rigor and genuine care to your work, this is your opportunity to make a lasting impact. About the Role This is a full-time, salaried position focused on supporting and conducting high-quality clinical assessments while contributing to strong foundational care for clients. You will play a key role in shaping treatment direction through detailed assessment work, collaboration, and clinical insight. Schedule: Monday through Friday during regular business hours Work Expectation: 40-hour work week Roles and Responsibilities As an Assessment Specialist, you will: Maintain a consistent 40-hour work week Assist in developing individualized treatment plans and clinical goals Support timely and accurate submission of clinical documentation Collaborate with clinical staff to ensure high-quality assessment practices Maintain accurate assessment records and ensure compliance with all internal and external standards Take on additional responsibilities as needed based on business needs This role is designed for someone who values structure, accuracy, and collaboration, and who understands that strong assessments are the foundation of effective care.