Clinical Contracts Manager
Indianapolis, IN, United States
Job Description:
Responsibilities:
Clinical Contracts Management (Site) is responsible for managing all aspects of vendor selection/contracting, negotiation/execution of other required agreements (e.g. LOIs) in support of the clinical development plan.
This role requires the ability to solve complex problems that require ingenuity, innovation, and creativity as well as experience working with clinical research phases I-IV.
The ability to collaborate with other clinical contracts team members, clinical trial teams, and vendors is imperative.
Collaborate with clinical trial teams and other internal stakeholders, vendors, and investigational sites to support timely study start-up to meet departmental and organizational goals.
Develop a study-level budget based on CRO benchmark data.
Manage the formulation of requests for information (RFI) and requests for proposals (RFP) for clinical services including the bidding process.
Contract and budget negotiation.
Manage the development and execution of Vendor Master Agreements and Scope of Work (SOWs).
PO generation and management
Ongoing contract management (e.g., spend, change orders).
Manage the development and execution of other agreements as needed.
When required, act as liaison between clinical service groups (SMO, CRO), and legal and clinical trial teams for outsourced trials.
Manage the negotiation efforts to resolve complex and deal breaker issues with external parties.
Develop contract concepts and techniques and solve complex contractual problems that require ingenuity, innovation, and creativity.
Qualifications:
BS degree in business administration, finance, science or a related field or equivalent on the job experience may be considered; advanced degree a plus.
Minimum 5-7 years of experience in pharmaceutical services with 2+ years of contract management and/or study start-up activities including contract negotiations and management.
High degree of organizational, analytical, and team management skills.
Ability to handle complex budgets.
Computer literacy with document and spreadsheet applications.
Ability to work on complex, multi-faceted projects.
Proven negotiation skills and vast knowledge of clinical trial agreements.
Demonstrated ability to work well with other accomplished professionals within and across functions/teams; Strong collaborator.
Strong communication skills both written and oral.
Ability to multi-task and shift priorities rapidly to meet tight deadlines.
Professional demeanor.
Detail-oriented and well-organized.
Good and thoughtful listener.
Enthusiastic, self-motivated, and keen to improve processes and overcome any inefficiencies.
Proficient in Microsoft Office suite and applications.
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