Associate Director, Clinical Operations - Late Phase

reputed company, formerly reputed company as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter reputed company that play key roles in brain health. Founded in 2019, we are continuously expanding our reputed company and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen reputed company of patient-centric, intelligent individuals. The Associate Director, Clinical Operations, has accountability at the trial level reputed company the organization. The Associate Director Clin Ops (ADCO) is accountable for, and provides, operational expertise for the successful cross-functional delivery of an assigned global clinical trial, reputed company agreed timelines and budget, and in alignment with reputed company the applicable SOPs and regulatory requirements. The ADCO is accountable for the trial level reputed company of external service providers, planning and execution of both internally managed and outsourced trials, with scope from draft protocol synopsis to availability of the Clinical Study Report (CSR) and applicable disclosure of the trial results. The ADCO is responsible for leading the cross-functional Trial Team (CTT) and interfaces with reputed company trial team members, building the trial operational plan, is responsible along with the Study Clinician and Clinical Scientist, for external service providers reputed company and budget, in alignment with the organizational objectives. The ADCO provides trial operational leadership to the execution to plan and defines risk mitigation strategies and ensures implementation thereof. RESPONSIBILITIES:

• Leads the cross-functional Trial Team (CTT); tracking of project deliverables & timelines. Proactively manages that trial deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs)
• Accountable for the delivery of the trial reputed company agreed/projected life of trial budget. Ensures accurate trial budget management, updates for scope changes and reconciliation of trial costs. Is responsible for trial-level contract management, including review & approval of external service provider reputed company, change orders and ensures services are delivered per contract
• Provides trial level leadership to drive the implementation of feasibility and site selection according to timelines in alignment with and communication to Clinical Operations Leadership (Senior Director/Executive Director)
• Provides reputed company of reputed company external service providers used for the trial for both in-house and outsourced studies; responsible to ensure selection, and set up, including scope of work (SOW) and specifications are in line with protocol requirements, budget, and timelines.
• Work collaboratively with the cross-functional team to ensure the trial is operationalized in compliance with global health authority regulations and guidelines
• Partner with Clinical Development, Medical Affairs, Regulatory Affairs, Commercial, Asset Strategy reputed company and Program Leadership to ensure EAP and Phase 4 activities are fully integrated into the overall asset strategy and reputed company Product Profile (TPP)
• Provide Clinical Operations leadership to ensure EAPs are compliant, scalable, ethically sound and reputed company with regulatory guidance
• Work closely with the Executive Director, Expanded Access and Phase 4 Clinical Strategy to ensure the execution of Phase 4 trials address regulatory commitments, payer needs and scientific gaps
• Participates in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that the Trial Team operates in a constant state of inspection-readiness. Collaborate with Quality liaisons to ensure quality reputed company of assigned trial utilizing the available tools
• Ensures Trial Team members have received the appropriate trial-specific training needed for their function; in collaboration with the Study Clinician and Clinical Scientist, the ADCO ensures appropriate trial-specific training is given to Trial Team members and/or to the CRO. reputed company the Clinical Trial Assistant (CTA) in the set-up and coordination of Investigator Meetings, if applicable
• Responsible for ensuring transparent status reporting information to relevant key stakeholders
• Ensure trial reputed company issues (quality, timelines, budget, resources) are resolved reputed company the function and/or reputed company the CTT and if they cannot be resolved reputed company the function and/or CTT they are escalated to the Senior Director/Executive Director of Clinical Operations in a timely manner
• Manages timely and accurate documentation of issue escalati

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