Manager, Clinical Outsourcing - The Fountain Group
Cambridge, MA
About the Job
This position reports into the Associate Director of Clinical Outsourcing. The right candidate will possess an understanding of Clinical Outsourcing activities for successful execution of multiple clinical trials primarily in oncology and hematology indications in various phases of development.
Responsibilities of this position involve the day-to-day management of issuing Request For Proposals (RFPs), review of proposals, selection of key study vendors, and management of change orders for the company's clinical trials in collaboration with a dynamic Clinical Development team.
Assists teams in the identification of potential vendors and CROs for clinical trial execution
Collaboratively creates and issues Request for Proposals (RFPs), compiles responses and facilitates team review of proposals from clinical trial vendors
Performs competitive bid analysis and derives recommendation to operational team leads
Participates in pricing negotiations for CROs, Central Laboratories, Imaging, ePRO and other critical study vendors
Leads and facilitates cross functional review vendor selection meetings
Leads the contracting activities including facilitating the review of MSA and amendments, development of Work Orders, Change Order notifications and Change Orders to ensure appropriate pricing and timely execution
Supports the development of Outsourcing processes and tools
Leads the facilitation, management of governance meetings for key vendors as assigned
Negotiates services descriptions, budgets, and payment schedules
Leads the negotiation of rates and vendor discount opportunities with vendors as assigned
Assists with benchmarking analysis
Collaborates effectively with all key functions including Clinical Operations, Finance, Legal, Biostatistics, PV, QA, Data Management, and Clinical Development to ensure appropriate stakeholder engagement in vendor selection and management.
Identifies and seeks efficiency in vendor contracting to ensure improved value for service
Assists in maintaining a central database of contract tracking and delivery of metrics
What basic qualifications do we require?
Minimum Education Required: Bachelor's degree in scientific or business discipline.
2 + years in vendor and contract management with a sponsor company or CRO managing various phase clinical trials.
What additional qualifications are we seeking?
Understanding of the drug development process
Experience with vendor selection (conducting RFPs, proposal review, and budget negotiations)
Experience with vendor oversight
Experience in contracts, legal agreements, and financial budgeting preferred
Experience in RFP procurement software a plus
Motivated self-starter who can work in a fast-paced environment
Creative problem solver with good communication and written skills
Strong interpersonal and organizational skills are needed, with a high degree of attention to detail
Proficient with the MS Office Suite especially Excel
Ability to work with minimal direction
Responsibilities of this position involve the day-to-day management of issuing Request For Proposals (RFPs), review of proposals, selection of key study vendors, and management of change orders for the company's clinical trials in collaboration with a dynamic Clinical Development team.
Assists teams in the identification of potential vendors and CROs for clinical trial execution
Collaboratively creates and issues Request for Proposals (RFPs), compiles responses and facilitates team review of proposals from clinical trial vendors
Performs competitive bid analysis and derives recommendation to operational team leads
Participates in pricing negotiations for CROs, Central Laboratories, Imaging, ePRO and other critical study vendors
Leads and facilitates cross functional review vendor selection meetings
Leads the contracting activities including facilitating the review of MSA and amendments, development of Work Orders, Change Order notifications and Change Orders to ensure appropriate pricing and timely execution
Supports the development of Outsourcing processes and tools
Leads the facilitation, management of governance meetings for key vendors as assigned
Negotiates services descriptions, budgets, and payment schedules
Leads the negotiation of rates and vendor discount opportunities with vendors as assigned
Assists with benchmarking analysis
Collaborates effectively with all key functions including Clinical Operations, Finance, Legal, Biostatistics, PV, QA, Data Management, and Clinical Development to ensure appropriate stakeholder engagement in vendor selection and management.
Identifies and seeks efficiency in vendor contracting to ensure improved value for service
Assists in maintaining a central database of contract tracking and delivery of metrics
What basic qualifications do we require?
Minimum Education Required: Bachelor's degree in scientific or business discipline.
2 + years in vendor and contract management with a sponsor company or CRO managing various phase clinical trials.
What additional qualifications are we seeking?
Understanding of the drug development process
Experience with vendor selection (conducting RFPs, proposal review, and budget negotiations)
Experience with vendor oversight
Experience in contracts, legal agreements, and financial budgeting preferred
Experience in RFP procurement software a plus
Motivated self-starter who can work in a fast-paced environment
Creative problem solver with good communication and written skills
Strong interpersonal and organizational skills are needed, with a high degree of attention to detail
Proficient with the MS Office Suite especially Excel
Ability to work with minimal direction
Source : The Fountain Group
