Outsourcing Lead

RESPONSIBILITIES

- Provides contracting and outsourcing expertise in support of Business Units (BU)/Research Units (RU).
- Directly negotiates clinical operations fees and services with Partners.
- Directly negotiates business terms with vendors in support of sourcing strategies.
- Processes service-related agreements.
- Oversees Per Subject Cost estimation and clinical study agreements activity.
- Directly negotiates contracts within the parameters identified by the Legal Division.
- Reports to Business Operations Outsourcing Group Lead (Alliance Partner facing).
- Properly coordinates and manages sourcing process on behalf of BU and Development Operations: Understands study requirements to secure appropriate level and type of resources and services from Contract Research Organizations (CROs), analyzes bids, identifies and brokers study execution options, selects vendors in connection with the outsourcing of clinical-related services to Labs and Consultants, such services totaling in the millions of dollars.
- Understands clinical trial operations in order to evaluate feasibility of contract, work breakdown structures and outsourcing needs.
- Gathers in-depth study specifications in collaboration with study teams to enable the compilation of study budgets and work orders.
- Ensures that the company enters into mutually beneficial contractual agreements by negotiating in an agreed legal and budgetary framework.
- Communicates impact of significant contractual changes and associated budgets to BUs.
- Proposes program level or study specific solutions to study teams.
- Provides budget estimates and modelling options of Alliance Partners or CROs costs; oversees the development of Per Subject Costs (PSC) and associated site investigator grants (US and World).
- Liaises frequently with customers and stakeholders to ensure they have realistic expectations of the contracting process, external providers and the contracting environment.
- Provides outsourcing expertise to project teams by identifying and evaluating all outsourcing and resourcing options available in order to facilitate decision making of optimal high value strategy at a global and local level.
- Implements global tools to best support and improve outsourcing management and supplier practices.
- Responsible for obtaining 'Real Time' external knowledge, expertise, feasibility data (supplier surveillance) and assessment of external commercial market place.
- Directly negotiates proposed changes to standard contract language within guidelines provided by the Legal Division; raises significant requested changes to standard contract language to the Legal Division and significant budget exceptions to the appropriate management for consideration.
- Is accountable to minimize business risk, and maximize research dollars in each contract.
- Prepares or directs the preparation of documents in connection with outsourcing of services such as, Request for Proposals, Work Orders, Vendor agreements, Change Orders.
- Coordinates and manages all contracting support for projects sponsored by BUs.
- Collaborates with the Global Business Operations organization and Legal in order to develop improvements to document templates and standard processes and tools.
- Designs payment schedules in order to ensure that payments are made to vendors, according to milestones, for properly performed work.
- Proactively identifies operational process issues and collaborates with Group Lead and Business Operations staff to develop process solutions.
- Proactively manages customer relations and possible issues.
- Collects and maintains information for performance metrics and management (eg Balanced Score Cards).

SKILLS

Knowledge of project budgeting and understanding of project resource needs, ability to translate study requirements into effective contracts. Demonstrates advanced understanding of legal concepts and principles as they relate to: Confidentiality, Service, Investigator and Consulting agreements.
BA or BS degree (preferably in a related discipline), and clinical trials experience, including significant experience negotiating and drafting clinical trial-related agreements is required; or MBA, JD or other graduate's degree and experience in negotiating and drafting clinical trial-related agreements is preferred. Excellent verbal/written communication skills is required.

Prior Experience Preferred:
Knowledge of the clinical development process; previous work history in clinical research and in negotiating and drafting of contracts. Experience working with, or in, Contract Resource Organizations (CROs). Understanding of contracting principles and applicable regulations governing clinical research. Demonstrated effective influencing, negotiating, interpersonal, leadership, and team player skills. Customer focused and solution oriented. Excellent analytical and financial skills. Strong computer skills.

Has the functional and technical knowledge and skills to do the job at a high level of accomplishment. Acts Decisively and makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision. Makes good decisions based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions. Seizes Accountability and will stand up and be counted; doesn't shirk personal responsibility; can be counted on when times are tough; willing to be the only champion for an idea or position; is comfortable working alone on a tough assignment. Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results. Change Agile and can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty. Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer resources. Knows personal strengths, weaknesses, opportunities, and limits; seeks feedback; gains insights from mistakes; is open to criticism; isn't defensive; is receptive to talking about shortcomings; looks forward to balanced (+'s and -'s) performance reviews and career discussions. Is aligned with the culture, values and mission of the company. Operates with the mission and values in mind. Encourages others to act in a manner aligned with organizational culture, values and mission. Communicates a compelling and inspired vision or sense of core purpose; talks beyond today; talks about possibilities; is optimistic; creates mileposts and symbols to rally support behind the vision; makes the vision sharable by everyone; can inspire and motivate entire units or organizations. Can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.

Technical Competencies:
Finance/clinical budgeting. Understands components of clinical & per subject costing & use of industry benchmarking. Operational expertise in study scheduling and placement. Knowledge of clinical study outsourcing. Negotiating and contracting skills. Knowledge and experience of contracting with external service providers.

Synectics is an Equal Opportunity Employer.