Senior Clinical Outsourcing Specialist
2 weeks ago
Position: Clinical Outsourcing Manager
Location: Remote
Duration: 6 Months
Job Type: Contract
Work Type: Onsite
Pay Rate: $70-$75/hr
Job Overview:
We are seeking a highly skilled professional for the role of Clinical Outsourcing Manager within our Development Business Operations division. This position offers the chance to lead and manage the entire lifecycle of clinical outsourcing for global Phase 1b-Phase 3 clinical trials.
Key Responsibilities:
- Formulate and execute a global clinical development vendor strategy, particularly focusing on Cell Therapy.
- Oversee contract and sourcing operations for clinical development programs, ensuring exceptional customer service and delivering measurable value through cost efficiencies and innovative practices.
- Lead the contract negotiation process, managing all phases from vendor identification to agreement closeout, ensuring maximum contract value and compliance.
- Collaborate with cross-functional teams, including Compliance, Legal, and Regulatory, to mitigate risks and enhance vendor selection processes.
- Engage with internal stakeholders to develop study specifications and utilize benchmarking tools effectively.
- Act as a subject matter expert in resolving complex contract negotiation and management issues.
- Manage relationships with global external service providers and lead vendor bid defense meetings.
- Demonstrate a comprehensive understanding of regulatory and legal considerations in clinical development.
Strategic and Innovative Thinking:
- Analyze and synthesize information from diverse sources to inform decision-making.
- Identify and implement best practices in vendor selection and category management.
Problem Solving and Decision Making:
- Take ownership of issues from identification to resolution, ensuring effective solutions are implemented.
- Make informed decisions regarding clinical vendor agreements and escalate high-risk issues as necessary.
Communication and Collaboration:
- Exhibit excellent communication skills, engaging effectively with stakeholders at all levels.
- Train internal teams on contract management and budgeting processes as needed.
Qualifications:
- Relevant experience with a BA or MS in a related field; MBA or JD preferred.
- PMP/CPSM certification or equivalent is a plus.
- Proven expertise in the end-to-end sourcing and contracting process, including RFx and contract negotiation.
- Strong financial acumen to analyze and understand complex budgets.
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