Remote Manager Clinical Outsourcing
45 Sidney Street Cambridge, MA 02139 US
This position reports into the 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.
What will be your responsibilities?
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 he 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.
- CONTRACT MANAGEMENT
- CLINICAL TRIALS
- ORGANIZATIONAL SKILLS
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
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