Title: Mgr, Clinical Contracts & Finance Location: Foster City, CA or Parispanny, NJ or Santa Monica, CA Duration: 12 months
Description:
Currently seeking an industry leader for Sr. Manager, R&D Outsourcing within our Development Business Operations department. The Sr. Manager will have the opportunity to provide category management, sourcing and contracting expertise in clinical outsourcing of global Phase 1b-Phase 3 clinical trials.
The Sr. Manager will lead the entire life cycle including vendor selection, RFI, RFP, vendor selection decision, contracting, monitoring performance, change orders and ensuring proper closeout of clinical agreements, with a focus on Clinical Research Organizations (CRO).
The position will have the opportunity to work in a matrix environment and regularly collaborate with Senior Management and cross functional teams.
The core responsibilities and skills required for this position include but is not limited to: Delivery Excellence • Develops global clinical development vendor strategy for a program or therapeutic area with a focus on Cell Therapy • Manages contract and sourcing activities for Phase 1b-3 clinical development programs providing consistent customer service and delivering quantitative value through cost savings and transformation/innovation • Develops and implements sourcing strategies to support given scope • Manages the contract negotiation process across the entire life cycle including RFI, vendor identification, RFP, vendor selection decision, contracting negotiation, performance monitoring, change orders, and ensures proper closeout of agreements to maximize contract value and achieve target savings • Ensure the vendor selection process is compliant by managing risks through benchmarking, rate negotiations, implementing the sourcing strategy, collaborating with cross functional teams such as Compliance, Legal and Regulatory • Collaborates with internal customers in vendor bidding and proposal development (RFP creation and analysis) • Partners with internal customers to develop study specifications and leverages benchmarking tools as appropriate • Translates business requirements into vendor capabilities and develops recommendations for vendor selection for a program or therapeutic area • Is an SME in resolving complex issues relating to contract negotiation and management • Oversees the identification, selection and management of global external service providers • Leads Vendor bid defense meetings • Manages the contract negotiation process for complex or high value contracts • Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development Strategic Thinking • Ability to understand, analyze and develop recommendations from multiple complex sources such as financial and operational perspectives • Influence vendor selection with stakeholders at the project team level Innovation • Identifies, develops, and deploys best practices in vendor selection, cost containment, and category management practices • Leverages prior experience with external benchmarking, industry best practices, and technology for continuous improvement Problem Solving • Takes ownership of issues from problem identification to successful resolution, testing recommendations for reasonableness • Triages study-level vendor management issues; escalates high-risk issues to appropriate stakeholders • Translates trends in operational and systematic issues and develops solutions with sustainability in mind to ensure roadblocks are removed during study start-up Influence and Partnership • Engage with clinical operations leadership to drive sourcing strategy, compliance, and continued partnership • Exhibits competency in regularly establishing relationships with internal and external cross functional teams, such as clinical operations, legal, finance, compliance • Partners with internal stakeholders working on contracts in resolving complex issues relating to contract negotiation or management • Manages study level vendor relationships in conjunction with Clinical Operations Decision Making • Delivers value by developing business solutions by translating requirements into effective sourcing solutions, contractual terms and process improvements • Demonstrated ability to make critical decisions related to clinical vendor agreement negotiations and escalations • Pulls data across functions according to business requirements and recommends global development vendors to senior leadership for endorsement for a project • Asks probing questions to uncover business needs and recommends solutions (e.g., negotiating timelines while maintaining standards) • Resolves vendor project management issues (e.g., operational challenges including scoping issues) by identifying and addressing deviations from established protocols • Identifies operational and systematic issues, including frequency and escalates to the appropriate level Communication • Excellent communication skills and comfort level interacting with internal and external teams across all levels, including regular interface with stakeholders and leadership team members • As necessary, trains internal stakeholders in contract budgeting, development, and administration
Capabilities and Requirements • Experience in providing thought leadership and consistent customer service • Expertise in the end-to-end sourcing and contracting process, including RFx, contract negotiation and management • Demonstrates an in-depth knowledge of the clinical research process and the regulatory environment across functions • Demonstrated leadership skills while working in fast paced and changing environment • Financial acumen to review, analyze and understand cost drivers of complex budgets • Legal, clinical operations and regulatory acumen • Travel may be required
Knowledge, Experience and Skills: • Relevant experience with a BA or MS in a relevant discipline • MBA or JD preferred • PMP/CPSM certification or equivalent a plus
CPRA: The Company is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $70.00/hr.
