Associate Director Clinical Operations Position Available In New York, New York

Job Description Align with the Head of Clinical Development Operations or Director, Clinical Operations on plans for the successful implementation of studies. Responsible for the management of compounds at the program and franchise levels and may represent Clinical Operations on the Strategy and Portfolio or Clinical Sub Teams in their therapeutic area. Ensure operational aspects are incorporated into CDP planning and individual protocols to facilitate successful implementation of programs. Responsibilities Ensure high-quality delivery of all studies for which you are responsible, including individual studies as well as programs or franchises. Lead the study team to develop a cross-functional, integrated study plan and create an initial study budget when sitting on a study team. Review study feasibility assessments provided by the CRO(s), lead the CRO selection process, and provide input into ARO selection. Validate the study implementation plan provided by the CRO through to study close-out and CSR writing. Ensure the timing of major study milestones and the associated budget meet the needs of the overall development plan agreed to by the Global Project Team (GPT). Lead site selection and site qualification discussions, kick-off meetings, and study team meetings. Oversee the CRO and provide timely input to ensure that the study is executed according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential risks to the study and propose mitigation plans. Responsible for oversight of all CROs utilized within their therapeutic area. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all studies falling under your responsibility. Design, update, and implement appropriate innovative and best-in-class procedures and SOPs related to clinical study oversight and execution. Work with TMF Operations to ensure a state of inspection readiness for all TMFs and ensure quality expectations are met. Manage CRO(s) performance to ensure adherence to the scope of work within timelines and budget at an overall study level. Track major study milestones and monitor overall operational performance metrics through the life of the study. Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to the appropriate governance committee. Create the budget at study start-up and monitor the overall agreed budget against trial progress. Essential Skills 7+ years of clinical trial management experience. Experience with global study management (Any Phase I-III). Vendor/CRO management and oversight. Strategic leadership ability with experience working in a matrix environment. Experience in clinical research and hematology. Experience with study start-up and monitoring. Must have a current or previous title of Associate Director/Director. Additional Skills & Qualifications Oncology or Hematology experience. Early development experience in oncology is a plus. 6-8 years in CTM/Director roles. 4-year degree