Site Oversight Manager

Draig Therapeutics is an exciting, rapidly growing clinical-stage biotech backed by a transformative $140 million Series A financing - one of the largest ever in neuropsychiatric drug development. We are pioneering innovative small-molecule therapies aimed at fundamentally transforming the treatment landscape for depression and neurological disorders. Why Join Draig? At Draig Therapeutics, you’ll join a science-first, mission-driven biotech that is redefining what a small, agile, and deeply collaborative organization can achieve. Backed by strong investors and propelled by a bold CNS discovery pipeline, Draig brings together world-class scientists, a caring culture, and the energy of a company on an incredible growth trajectory. Here, innovation and speed aren’t just encouraged - they’re expected. You’ll partner closely across Discovery, Nonclinical, and Clinical Development, helping to shape programs that have the potential to transform patient lives. This is an environment where your voice matters, your expertise has real impact, and your work directly influences how promising molecules move from concept into the clinic. At Draig, you won’t just contribute to groundbreaking science - you’ll help build a biotech with purpose, speed, and heart. For more info, please visit our website. Responsibilities The Site Oversight Manager will be responsible for the clinical monitoring oversight with Draig vendors at study sites. Conduct comprehensive monitoring oversight visits to ensure sponsor oversight of CRA and CRO monitoring processes Document monitoring oversight visits, visit outcomes, and action plans via detailed reports and follow-up correspondence Review a percentage of monitoring reports for sponsor oversight of CRA and CRO monitoring process Review site data in study and vendors' systems (i.e., EDC, IRT, eCOA, etc) for queries, response to CRAs/DM, deviations, reports (drug supply, canceled reports, etc.), trends, and risks Review CTMS for outstanding monitoring action items, deviations, trends, and risks Assess and maintain quality and integrity of study site practices, escalating concerns as needed Review ISF in accordance with the study phase, timelines and TMF in compliance with regulations Review the Trial Master File (TMF) and file the monitoring oversight reports Manage the monitoring oversight plan and meetings with the CRO. This includes discussions with the CRAs following monitoring oversight visits Discuss study needs and/or issues with the site staff, including PIs, Sub-Is, and Study Coordinators (as needed) Collaborate with study team members, providing essential monitoring oversight and project execution support Additional Tasks Contribute to developing project-specific and/or site-specific subject recruitment plans Participate in peer review of SOPs or Work Instructions Education and Experience 5 years of CRA experience, including extensive monitoring for phase 1, 2, and/or 3 clinical trials Minimum 10 years of prior research experience at Pharma/Biotech, CRO, and/or site Mental health experience Prior management of a monitoring oversight program While US-based, travel regularly, countrywide, and globally Knowledge of ICH and GCP guidelines Ability to operate independently and in a cross-functional team Adaptability Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty. Collaboration Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Involves others in decisions and plans and credits them for their contributions and accomplishments. Execution Drivers execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high-quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives. Relationship Building Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity, and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity. Location: Hybrid, Metro Boston, USA, London, UK, and Cardiff, UK When You Join Draig Therapeutics, You Will Have: Customized and competitive health coverage, including medical, dental, and vision US: Healthcare Saving Account for medical and dependent care expenses US: Eligible from the first day for 401K, no matching US & UK: A robust package of Draig-paid insurance coverage, including life insurance, short-term, and long-term disability Generous vacation allotment Draig Therapeutics, Inc. is an equal employment opportunity employer. It does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law. #J-18808-Ljbffr Draig Therapeutics