||Outsourcing Manager/Sr. Outsourcing Manager
||October 15, 2019
||Full time Employee
||Director, Clinical Contracting & Outsourcing
|MANAGERIALLY RESPONSIBLE FOR:
ESSENTIAL JOB FUNCTIONS:
- Responsibilities include all aspects of research and development contracting and vendor management. Provides functional guidance and keeps internal and external team aware of all contract status or pending issues. Establishes strong working relationships with internal departments and project teams, sites, vendors and CROs.
- Accountable for the management of clinical trial outsourcing details including RFI, RFP, Work Orders, Changes in Scope, negotiations and approvals.
- Responsible for implementing tools and templates for the maintenance of a consistent outsourcing and contracting process across studies.
- Responsible for the preparation of sufficiently detailed Request for Proposal documents in cooperation with internal clients including an optimal balance between costs, time and quality considerations
- May supervise outsourcing staff
- Leads selection teams in selection processes, and provides on-going support to clinical teams during the life of a study
- Leads Study Handoff Meetings in collaboration with Finance and Legal
- Facilitates negotiation and preparation of contracts, budgets, and related documents, including but not limited to CTAs, change orders, and scopes of work, in support of all research and development activities. Reviews contracts and budgets for completeness and accuracy and ensures that corrections are appropriately made and documented.
- Facilitates and supports contract management tasks with internal and external legal, finance, as well as clinical and other departments, including communicating and explaining contract and budgetary issues
- In consultation with Legal, proposes alternative contract and/or budget terms acceptable to the Company when vendor / site and Company terms and conditions differ
- Anticipates risk/benefit issues, assists with remedial action plans, and troubleshoots to resolve any concerns.
- Works with CC&O Managers or other staff with active project management of ongoing contract and budget issues; performs follow-up on all outstanding contract and budget issues.
- Works with Legal in generating amended documents as necessary and preparing contract management documentation for projects.
- Works with Finance in projecting and tracking trial and project accruals
- Supports the Clinical Operations team in managing provider relationships on a day-to-day basis to ensure high quality service delivery and to address/escalate issues as appropriate
- Tracks provider performance and prepare trending analysis to identify and mitigate risk
- Accountable for maintaining strong relationships with assigned strategic or preferred providers
- Provides information to Senior Management on vendor performance issues
- Streamlining the contract/proposal or internal processes by working with different functions to determine an effective and efficient workflow; initiates and introduces creative ideas and solutions.
- Serves as communication liaison between vendor and site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues.
- Prepares and inputs PO into the Finance system
- Participates in Study closeout in coordination with Finance and Clinical Operations
- Performs other work-related duties as assigned, including support to other start-up functions as required.
- Travel may be required (up to 30%).
- BA/BS degree in related field or equivalent combination of education and experience
- Minimum of 5 years for Manager level, 7 years for Sr. Manager level in clinical research, contracts, budgets or related experience that includes working in a team-oriented environment
- Possesses a working knowledge of the regulatory and business risk for all research and development contracts and budgets
- Ability to work in a fast-paced environment
- Ability to critically read documents and interpret/draw conclusion from the documents
- Must have attention to detail and strong negotiation, project management, communication, organizational, documentation, and interpersonal skills
- Ability to identify risk and propose solutions
- Strong analytical and strategic thinking
- Strong skills in Microsoft Office Suite
- Ability to actively prioritize multiple tasks to meet deadlines in a dynamic environment
Employee frequently works in a professional office environment and lab with lots of computer/lab equipment, tools, and moderate amounts of noise and activity. Employee may occasionally be required to travel. The work environment is fast-paced and demanding. Off-shift, weekend and overtime duties may be required as assigned by the manager.
Kura Oncology offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to firstname.lastname@example.org