Assoc Director Clinical Operations

Our Biopharmaceutical client is focused on the treatment of cancer, inflammatory and infectious diseases. They are looking to double in size over the next year. This is a company that has a technology that is very unique to them as well as beyond competitive benefits.

As an Associate Director of Clinical Operations you will provide oversight and support of clinical study teams in planning, tracking, and managing the operational delivery and financial conduct of studies.You will be accountable for global protocol execution for assigned clinical studies. Manage assigned clinical studies with direct oversight of project timelines, critical path milestones, clinical supply forecasting and tracking, project budgets, and vendor management. Provide mentoring and oversight of CRAs and CTAs assigned to support the studies. Identifie and communicates critical path activities along with risks, issues, or resource requirements pertaining to project plans and timelines and works with the study team to develop appropriate solutions. Develop strategic/ operational planning and risk management plans, and utilizes project management analytical methods to assess progress and risk. Provide oversight of clinical study budgets including planning, forecasting, and tracking of financial positions. Manage vendor relationships including procurement, contract negotiations, quality control, delivery according to specifications, and overall performance assessment. Coordinate cross-functional activities in support of study conduct including site management, drug supply, regulatory, financial, and legal. Support clinical study teams with the management of clinical supplies globally including supply and re-supply planning and tracking of study investigational compounds. Contribute to the trial specific document development process including protocols, electronic case report forms, and operational plans. You will be responsible for compliance of work products to internal and external regu-lations to avoid unacceptable risk to the project, program, or functional area. Ensure standard processes, tools, and procedures are followed consistently and globally. Support the Director, Clinical Operations in departmental projects including continual process improvement related to study management, information and tracking systems, document management, metrics, cost and resource analysis, and the development of or enhancement of clinical operations SOPs. Directly manages 1-3 staff including CRAs/CTAs.

Bachelors required; MS / MBA preferred. Knowledge of broad clinical trial functional areas and their respective deliverables including document management, regulatory affairs, monitoring, data management, safety, medical affairs, medical writing, and statistical analysis. Working knowledge of GCP/ ICH regulatory guidelines.

Minimum 8 years clinical research experience. Minimum 6 years experience or equivalent at a project manager level or above including management of study resources, budgets, supplies, critical path activities, and risk management. Minimum 2 years experience as a direct supervisor of clinical trial staff. Experience managing global studies. Experience managing within a matrix management organization preferred. Proficient with project management tools and analysis of metrics. Oncology experience preferred. This is an in-house position with travel estimated less than 20%; however must have willingness to travel to meetings and vendors based on study demands.