Sr. Outsourcing Associate, Clinical Outsourcing

Responsibilities

• Supports the preparation and tracking of site agreements.
• Maintains progress of contract negotiation and execution and provides regular updates to all stakeholders.
• Cultivates and supports long-term relationships with vendors.
• If applicable, negotiates Clinical Trial Agreements and site budgets with US and Canadian sites.
• Oversight of third-party negotiations of global Clinical Trial Agreements / Site Budgets.
• Partners with vendors and internal stakeholders to identify, manage, escalate and resolve issues related to vendor performance.
• Maintains Clinical Outsourcing team Outsourcing Plans, Timelines and Processes.
• Effectively communicates, develops and cultivates operationally excellent internal cross-departmental and external vendor relationships to enable advancement of clinical development programs.
• Negotiates change orders and ensures vendors adhere to contract terms.
• Assists with the generation of Request for Information (RFIs), Request for Proposal (RFPs), and assists 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).
• Supports the identification, development, improvement and implementation of processes and tools related to outsourcing activities.

Requirements

• BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered.
• 3-5+ years of related experience in a Biotech or Pharmaceutical organization.
• Exposure to 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.
• Exposure to RFI/RFP development, proposal evaluation, and contract and budget management.
• Strong organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
• Advanced knowledge in MS Excel, Word, PowerPoint, Outlook and Smartsheet.
• Must be a self-starter.
• 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.
• Absolutely 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.
• A high sense of accountability/urgency.

Qualifications

• Prior experience in small pre-revenue companies.
• Experience in working across a wide variety of functions supporting the drug development process and specialty service vendors.
• Experience in trials with varied outsourcing models.

Skills

• Excellent computer skills including advanced knowledge in MS Excel, Word, PowerPoint, Outlook and Smartsheet.
• Strong organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
• Advanced knowledge in MS Excel, Word, PowerPoint, Outlook and Smartsheet.
• Strong communication skills, including the ability to understand and present budget information effectively.
• Fluent in English (verbal and written).
• A high sense of accountability/urgency.

Benefits

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.