Director Clinical Operations

Director Clinical Operations $150K - $180K Must be willing to be in-house in Boston (Prudential Center, Boylston Street, four days per week) Our organization is seeking a Director of Operations to lead our operations team and ensure our business's efficient and effective running. The successful candidate will develop and implement operational strategies, manage day-to-day operations, oversee staff, and ensure compliance with applicable laws and regulations. We are looking for an experienced professional with strong leadership skills, a commitment to customer service, and an ability to think strategically. Responsibilities: Develop and implement strategies for operational excellence. Manage and coordinate the daily operations of the organization. Monitor the performance of operations and take corrective action when necessary. Develop and implement policies and procedures to ensure compliance with applicable laws and regulations. Develop, monitor, and evaluate key performance indicators (KPIs). Lead the organization in process improvement initiatives. Develop and maintain relationships with external stakeholders. Analyze data to identify trends and opportunities for improvement. Provide leadership and manage end-to-end processes involved in outsourced clinical trials; key deliverables are: Maintaining and remediation of operational efficiency at RT and designated CRO demonstrated by meeting development program goals per plan and within agreed upon budget Influencing, advising on, and analyzing study conduct issues and creating optimized and documented systems for study conduct at sponsor, CRO, and research site levels Direct site interaction managing site-specific subject identification, data entry oversight from a Clin Ops perspective, point of escalation for reimbursement issues The final responsibility for research site contract and budget negotiations Subject Matter Expert (SME)on ICH E6 rev 3Exercising consistent judgment and discretion within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for GCP-compliant and phase-appropriate study conduct Functional lead and responsible for GCP compliance and remediation in conjunction with the Head of QA Core member of infrastructure development team clinical business lead for infrastructure evaluation and implementation Core NDA preparation team member planning role Reviewing and authoring assigned sections Coordinate timing and quality of deliverables from ESPs Candidate Profile BS minimum degree requirement, MS or MA is preferred; an RN, BSN, FNP, PA experience is a plus Internally motivated to deliver high-quality work products on time and within budget Excellent communication and planning skills 10+ years of clinical trial operations experience and experience working in a smaller, fast paced environment highly preferred. Practical and broad experience with key elements of clinical trial management, including streamlining operational activities of trial protocols and ensuring deliverables are attained in a timely manner Extensive experience with the identification, negotiation, management, and oversight of external vendor partnerships, such as CROs, for site activation and monitoring, data handling, medical writing, and safety reporting Experience building an internal clinical operations management function as well as hiring internal stakeholders to support trial needs and leveraging external consultants as needed Experience running and overseeing internationally conducted studies in rare-disease indications Experience with regulatory submissions, especially including INDs, annual reports for INDs, ODD, and FTD Able to prioritize multi-faceted roles against dynamic timelines and rapidly changing corporate needs Advanced working knowledge of Microsoft Excel, PowerPoint, and Project Bonus: working experience using SmartSheets®, One-Pager Pro, Medrio and Oracle clinical databases