|Location||Princeton, New Jersey, United States|
This position assists the Associate Director, Strategic Clinical Outsourcing and Vendor Management in coordinating global strategy for the identification, assessment, selection, negotiation, contract execution and relationship management with Clinical CRO’s and other vendors to support human clinical trials. The position will liaise closely with R & D functions and Legal/Contracts, Finance Departments, as required, to support the outsourcing objectives as well as ongoing vendor management for the programs. The individual must be experienced in contracts management and be capable of working on complex initiatives with high monetary value; possess excellent relationship building and management skills. The incumbent will have demonstrated excellent organizational skills and understand the processes involved with the work in an in depth manner for GCP, GLP and GVP sourced work. The role will support the Request for Information (RFI) and Request for Proposal (RFP) processes from end to end. Skill, tact and diplomacy will be needed when handling sensitive issues with vendor award and delivery. The role will demonstrate competence with computer platforms to request and amend contracts, monitor and update purchase orders, and monitor invoicing. The role will involve maintaining solid partnerships with the CROs/vendors, R & D leadership and specifically Clinical Operations leads, Procurement, Legal/Contracts, Finance, and other departments, as appropriate, to ensure that outsourcing and contracting vendor needs are met and handled in an optimal and efficient manner that is consistent with company policy, as well as legal, government, and regulatory requirements, where relevant.
- Assists with vendor identification/vendor selection/vendor negotiation/vendor contract management activities in support of all human studies conducted within Clinical Research/Translational Research.
- Works closely with Associate Director, Strategic Clinical Outsourcing and Vendor Management, Clinical Operations and Finance teams, as well as relevant functional leads to support the clinical studies’ vendor budgets and contracting needs, including change orders from CRO’s and other vendors, risk reward proposals, earn backs, volume discounts and pricing terms.
- Assists in the development of Requests for Information (RFI) and RFP, critically evaluates proposals, coordinates bid defense meetings, and negotiates rate cards and preferred supplier terms.
- Maintains clinical vendor relationships in conjunction with Clinical Operations Teams and functional leads.
- Maintains the active vendor list.
- Assists with following up on vendor performance or invoicing issues and action items.
- Assists the development of Investigator Grant costing and benchmarking.
- Develops and maintains a system for tracking progress and status of all clinical budgets/contracts/MSAs and change orders.
- Assists with maintaining the active vendor list.
- Produces regular status reports on all clinical budgets/contracts/MSAs and change orders in progress.
- Assists, and may lead the Vendor Governance oversight activities, and participates in the development and tracking of performance metrics.
- Supports Clinical Outsourcing with data collection and analysis.
- Assists with the tracking of negotiated savings achieved.
- Supports departmental initiatives to streamline and improve processes.
Education/Experience/Skills: BS/BA or equivalent combination of relevant education and applicable job experience will be considered. A minimum 5 years of progressive experience with vendor, contracts and budgeting administration within a pharmaceutical clinical research and clinical operations organization. CNS therapeutic experience preferred.
- Familiarity with financial budgeting and forecasting reports
- Ability to establish priorities, schedule and meet deadlines
- Ability to take initiative, be flexible, exercise good judgment, interface with all levels of management, multi-task and have an excellent attention to detail to ensure efficient and cost-effective contract solutions are achieved
- Ability to effectively work with investigators, vendors, and internal colleagues
- Demonstrated success in working collaboratively within cross-functional teams and a matrix organization
- Strong working knowledge in MS Excel, MS Word PowerPoint, and Outlook a must
- Strong working knowledge of computer and project management software packages
- Knowledge of current regulatory requirements and guidelines governing clinical research
- Candidates must possess excellent organizational, communication and administrative skills as well as an ability to interpret and comprehend contract documentation, and contracting units, in unit cost models.
- Requires strong attention to detail
- Excellent written and oral communication
- Available for up to 10% domestic or international travel
Manages segment to achieve goals in accordance with established policies, meet schedules and resolve problems; may provide direction to and review of managers, supervisors, or employees. Works on abstract problems that may cross functional areas. Interacts with management on matters concerning functional area.
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.