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Oruka Therapeutics · 1 day ago

Manager/Senior Manager, Clinical Outsourcing

United States

Full-time

Remote

Mid, Senior Level

$125K/yr - $155K/yr

4+ years exp

Oruka Therapeutics is developing novel biologics for chronic skin diseases and is seeking a Manager/Senior Manager for Clinical Outsourcing. This role involves supporting vendor and site agreements for clinical trials, including contract negotiations and budget management, while collaborating with various departments to ensure high-quality clinical trial execution.

BiotechnologyHealth CareMedical

Responsibilities

Assist in the development of structure and processes supporting the newly created Clinical Outsourcing function within Clinical Operations

Drive the creation of complex RFI and RFP document templates

Lead and contribute to complex outsourcing initiatives and process improvement as identified

Creates effective partnerships with vendors to cultivate and support long term relationships

Negotiate Clinical Trial Agreements and site budgets with US and Canadian sites

Participates and assists with vendor governance activities as needed

Partners with vendors and internal stakeholders to identify, manage, escalate and resolve issues related to vendor performance

Manages corporate risk by working with legal to develop contracts that ensure services are completed with high quality and within budgets and timelines

Effectively communicates, develops and cultivates operationally excellent internal cross-departmental and external vendor relationships to enable advancement of clinical development programs

Negotiate final scopes of work, budget, and payment schedules with input from cross-functional stakeholders for clinical study service providers

Negotiates change orders and ensures vendors adhere to contract terms

Generates Request for Information (RFIs), Request for Proposal (RFPs), and assist Clinical Operations, Biometrics or Clinical Development with the service provider selection process including bid comparison analysis, bid defense coordination and leadership of proposal review meetings

Oversight and execution of contract lifecycle management for assigned clinical studies, vendors and/or program(s)

Drives the identification, development, improvement and implementation of processes and tools related to outsourcing activities

Key contributing member of the Clinical Outsourcing team

Qualification

Clinical outsourcingContract negotiationBudget managementRFI/RFP developmentVendor managementDrug development knowledgeCustomer service approachMatrix environment experienceFluent in EnglishCommunicationOrganizational skillsTime managementSelf-starterAttention to detail

Required

BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered

4-6 years of related experience in a Biotech or Pharmaceutical organization

Solid foundational understanding of drug development, clinical operations and clinical outsourcing

Ability to prepare/negotiate/track external provider work/change orders, etc

Excellent negotiation skills

Provide a customer service approach to internal team members

Must demonstrate an understanding of vendor budgets and payment terms

Experience in RFI/RFP development, proposal evaluation, and contract and budget management

Excellent organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively

Excellent computer skills including advanced knowledge in MS Excel, Word, PowerPoint, Outlook and Smartsheet

Must be a self-starter who works with limited supervision

Works effectively in a matrix cross-functional environment and can effectively influence stakeholders

Good business judgment and a strong understanding of the unique aspects of clinical financials

Must have the ability to interact with a diverse set of clinical team and functions across Oruka Therapeutics

Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present budget information effectively

High sense of accountability/urgency

Preferred

Preferred experience in RFI/RFP development, proposal evaluation, preparation/negotiation of clinical contractual agreements, manage contract lifecycle and budget management for assigned clinical project/operations

Experience in working across a wide variety of functions supporting the drug development process and specialty service vendors

Experience in rare disease and gene therapy