Job Details

 $80-95/hr pay rate depending on experience

Please see the below requirements from the hiring manager. The specific clinical outsourcing and clinical vendor selection experience is extremely important. Must have Clinops, GCP and regulation experience.

Must have:

• At least 5 years’ experience specific to biotech/ pharma/ CRO industry. Minimum of 3 of those years must be direct management of clinical vendor selection and clinical contract management.  Candidate may have experience in managing CRO (clinical research organization) contracts and vendors, and/ or other clinical trial vendors (FSPs, clinical systems/ data, PV/ safety, central labs, etc.)
  • If candidate does not have a BS in science, business, or law then at least 7 years’ experience.
  • Experience with indirect R&D, supply chain, preclinical, IT, etc. does not substitute for any of the above experience.
• Strong understanding of FDA regulations, GCP, ICH, etc. as it relates to global clinical studies.
• Understanding of clinical trial study budgets and long-term financial planning for trials.
• Has led RFIs/ RFPs for vendor selections in clinical trial space.
• Deep understanding of clinical trial vendor landscape.  Would need key words for kind of clinical contracting and vendor management they’ve done per types of vendors mentioned above (CRO, FSP, systems like IRT,EDC, TMF, PV safety, imaging, central IRB or laboratory, and so on).
• Cross functional collaboration within R&D functions needs to be mentioned. Would be nice if they mention leading cross functional initiatives, processes, or governance.

Nice to have:

• Experience (additional to min. 3 years in clinical outsourcing) in clinical project management, clinical contract analyst/ specialist/ negotiator, other clinical trial/ study related roles to gain better understanding of trial risks, escalation management, and overall trial processes.
• Preference to those who have stronger experience managing CRO selections and contracts as those are more complex than other clinical services.
• Clinical study financial management and global trial budget tracking and forecasting.
• Led clinical vendor governance including managing metrics/ KPIs, governance meetings, and oversight.
• Inspection readiness/ preparation experience.

Other, non-clinical sourcing/ procurement/ vendor and supplier management cannot substitute for the experience, nor can site contract managers.  Business development type roles also cannot substitute.

 We want someone who cares about this important work and is driven to connect to our mission of helping our patient communities. The Clinical Vendor Contracts Manager is responsible for relationship management, strategic insight, tactical support and execution of end-to-end outsourcing activities required to successfully execute clinical studies in a fast-paced and dynamic environment. They will partner cross-functionally to lead the selection, contracting, and ongoing management of the vendors who help make our trials successful.

 What you will do:
 

• Leveraging vendor knowledge and experience, individual will lead vendor selection activities through collaboration with Clinical Operations and others on the study team. Includes but is not limited to: identifying vendors, gathering business needs, leading RFPs, proposal reviews and bid defense meetings, scoring and award discussions, contract reviews, negotiating budgets and payment schedules, and executing contracts through the company’s Contract Management System. 

•  Manage contracting activities including preparation, finalization, and administration of CDAs, Service Agreements, Work Orders, Change Orders, and Amendments for assigned studies and/or program(s).
• Facilitate study kickoff meetings to clarify timelines, statements-of-work, roles and responsibilities, and budgets.
• Support the management of vendor relationships, ensuring expected outcomes are met or exceeded
• Monitor the outsourcing environment to keep current on providers and industry trends.
• Collaborate effectively with all relevant functional departments (e.g., Legal, Quality Assurance) to ensure appropriate review and approval of clinical vendors and vendor contracts.  

• Identify, lead, and participate in vendor outsourcing and other Clinical Operations process improvement projects
• Collaborate with QA and compliance to ensure quality management of vendors
• Management and oversight of study budgets for assigned studies including:
  • Maintaining established tools/trackers for management and oversight of study budgets for contract tracking purposes, and tracking budget to actual metrics
  • Proposing trade-offs within the study budget portfolio
  • Scheduling and leading study team financial reviews
  • Upon request work with Outsourcing leaders to contribute to annual budget review and Long-Range Planning (LRP) processes

Skills

• Bachelor’s degree required. MBA or advanced degree preferred
• At least five (5) years’ experience in the biotechnology/pharmaceutical industry with 3 to 5 years of direct experience in clinical vendor selection and budget/contract negotiation across early and late phase clinical studies in both the US and internationally
• Working knowledge and understanding of clinical trials budgeting software
• Experience and proven skills with study budget and project management
• Excellent understanding of the broad landscape of vendors involved in successful delivery of clinical studies
• Strategic & critical thinking supported by proven experience in negotiations, vendor management and conflict resolution
• Excellent analytical and problem-solving skills; ability to think on your feet and act with a consistent sense of urgency
• Attention to detail, and excellent organizational skills with the ability to multi-task, prioritize needs and manage a high volume of tasks within tight clinical deadlines
• Clinical Operations/Development experience with a thorough understanding of relevant regulatory requirements such as GCP, relevant ICH standards, and FDA/EMA guidelines.
• Excellent communication (oral and written) and presentation skills.
• Ability to create and collaborate with vendors and internal stakeholders
• Ability to work both independently and in a team environment.

• Proficiency in Microsoft Office