Director of Clinical Operations

Full Time, Temporary/Contract/Project, Employee Job Category: Biotech/R&D/Science Relevant Work Experience: 5+ to 7 Years Career Level: Manager (Manager/Supervisor of Staff) Company: Devon Consulting Contact: Steven Horner Phone: 610-964-5772 Reference Code: D8484 Director of Clinical Operations Our client locatd in Exton, Pa is in need of a Director, Clinical Operations. Candidate must have oncology and global trials experience. This will be a permanent opportunity. Division/Department: Clinical OperationsReports to: Director, Clinical OperationsJob Summary Provides oversight and support of clinical study teams in planning, tracking, and managing the operational delivery and financial conduct of studies Essential Functions Accountable for global protocol execution for assigned clinical studies.Manages assigned clinical studies with direct oversight of project timelines, critical path milestones, clinical supply forecasting and tracking, project budgets, and vendor management.Provides mentoring and oversight of CRAs and CTAs assigned to support the studies.Identifies 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.Develops strategic/ operational planning and risk management plans, and utilizes project management analytical methods to assess progress and risk.Provides oversight of clinical study budgets including planning, forecasting, and tracking of financial positions.Manages vendor relationships including procurement, contract negotiations, quality control, delivery according to specifications, and overall performance assessment.Coordinates cross-functional activities in support of study conduct including site management, drug supply, regulatory, financial, and legal.Supports clinical study teams with the management of clinical supplies globally including supply and re-supply planning and tracking of study investigational compounds.Contributes to the trial specific document development process including protocols, electronic case report forms, and operational plans.Responsible for compliance of work products to internal and external regu-lations to avoid unacceptable risk to the project, program, or functional area.Ensures standard processes, tools, and procedures are followed consistently and globally.In addition to job functions in support of assigned clinical projects:Supports 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.Job Requirements and Qualifications Education: Bachelors required; MS / MBA preferredKnowledge Requirements: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 guidelinesExperience:Minimum 8 years clinical research experienceMinimum 6 years experience or equivalent at a project manager level or above including management of study resources, budgets, supplies, critical path activities, and risk managementMinimum 2 years experience as a direct supervisor of clinical trial staffExperience managing global studiesExperience managing within a matrix management organization preferredProficient with project management tools and analysis of metricsOncology experience preferredOther Information Special Information (Travel required, physical requirements, on-call schedules, and etc.):In-house position with travel estimated less than 20%; however must have willingness to travel to meetings and vendors based on study demands.Strong attention to detail, good organizational skills, ability to work independentlyPlease send resumes to Steven Horner at Shorner@devonconsulting.com   Find An IT Job Find A Clinical Job Click here to learn about the benefits provided to Devon Consultants