Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:
Date Posted: 10/9/2018
Hiring Organization: Connexion Systems & Engineering
Job Title: Sr. Clinical Outsourcing Manager
Job Location: San Francisco, CA 94016
Employment Type: Full Time, Contract
Pay Range: Open
Duration: 3 months+
Sr. Clinical Outsourcing Manager
Responsible for outsourcing and contracting services provided throughout Drug Development. Provides direction, oversight and expertise to the organization in order to bring operational excellence to the business planning and financial management of clinical trials; and to the identification, selection and management of global external service providers. Oversees and maintains the relationship with contract research organizations. Evaluates and analyzes tools and processes to support outsourcing efforts. Contracts investigators for studies and ensures compliance with protocol and overall clinical objectives. Maintains a high level of professional expertise through familiarity with clinical literature.
Manage operational risks by making sound judgments, developing business solutions and applying a comprehensive cross-functional and industry understanding. Assist in development and implementation of a Source-to-Pay process that provides consistency and visibility to the methods and strategies used to identify, select, manage, contract and analyze the financial and service provider resources utilized to achieve the R&D objectives. Partner with colleagues in R&D to ensure the team is using consistent and efficient business processes and tools for outsourcing and vendor management that are compliant with GCP, SOPs, and corporate financial controls. Provide accurate and timely plans and forecasts for clinical trial cost estimates and budgets; ensuring efficient and compliant contracting of providers; validating of monthly expense accruals; and providing insightful analyses used to improve future planning.
Collaborate with Legal, Finance and other internal stakeholders on continuous improvement of processes and methodology for contracting with all clinical vendors. Apply strategic sourcing methodology to assure attainment of best service and value, and assuring vendor performance against agreed upon expectations. Operate within a rigorous and consistent strategy, methodology, and tools (e.g., forms, templates, checklists, etc.) for provider identification, qualification, selection, management and relationship governance, ensuring adherence to global compliance expectations. Effectively manage vendor agreements, support the oversight of transferred obligations, and ensure that clinical trial budgets are based on current operational assumptions. Interact with relevant Development Team members, and Functional Leaders to ensure appropriate providers are identified and managed efficiently. Perform any other tasks as requested by Senior Management to support Drug Development goals and project objectives. Monitor, control, and report expenditures against established contracts and budget. Monitor, control, and report performance metrics established for vendors.
A bachelor’s degree in clinical, biological or mathematical sciences or related field, or nursing qualification. A master’s degree is preferred. Equivalent experience may be accepted. A minimum of 9 years Pharmaceutical development experience with at least 5 years managing CROs is required. A minimum of 5 years previous management experience is preferred. Must have demonstrated problem solving abilities and strong organizational skills. Excellent written and verbal communication skills are required. Experience and understanding of ICH, and GCP is required. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills. Advanced knowledge of Data Management processes and systems. Solid understanding of clinical drug development processes is preferred. Ability to develop data management processes and training is preferred.
EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
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ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776