DCAM Outsourcing Lead

RESPONSIBILITIES

- Provides contracting and outsourcing expertise in support of BUs & RUs
- Directly negotiates clinical operations fees and services with Alliance 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
- 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 CROs
- Analyzes bids, identifies and brokers study execution options, selects vendors in connection with the outsourcing of clinical-related services to Labs and Consultants
- 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
- Uses knowledge of project budgeting and understanding of project resource needs to translate study requirements into effective contracts
- Provides budget estimates and modelling options of Alliance Partners or CROs costs
- Oversees the development of Per Subject Costs and associated site investigator grants (US and Global)
- 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
- Implements global tools to best support and improve outsourcing management and supplier practices
- Responsible for obtaining 'Real Time' external knowledge, expertise, feasibility data and assessment of external commercial market place
- Directly negotiates proposed changes to standard contract language within guidelines provided by Legal department
- Raises significant requested changes to standard contract language to Legal and significant budget exceptions to the appropriate management
- Minimizes the company's business risk & maximizes 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 department 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
- Demonstrates advanced understanding of legal concepts and principles as they relate to: Confidentiality, Service, Investigator MBA, JD or other graduate's degree and experience in negotiating and drafting clinical trial-related agreements is preferred. Excellent verbal/written communication skills are essential. Knowledge of the clinical development process and previous work history in clinical research and in negotiating and drafting of contracts is required. Must have experience working with or in CROs and an understanding of contracting principles and applicable regulations governing clinical research. Demonstrated effective influencing, negotiating, interpersonal, leadership, and team player skills are needed. Must be customer focused and solution oriented with excellent analytical and financial skills. Must have expertise in finance/clinical budgeting and an understanding of components of clinical & per subject costing & use of industry benchmarking. Operational expertise in study scheduling and placement is essential. Knowledge of clinical study outsourcing is required. Must have excellent negotiating and contracting skills, as well as knowledge and experience of contracting with external service providers. Must have 4-7 years of experience using MS Excel and MS Outlook.

Synectics is an Equal Opportunity Employer.