Clinical Contracts & Outsourcing Manager
The Clinical Contracts & Outsourcing Manager supports coordination and management of external service providers and other outsourcing needs for current and future clinical trials. Responsibilities include CRO/vendor/consultant identification, RFIs/RFPs, service provider selection, contract negotiations, budget management and service provider performance metrics. The Clinical Contracts & Outsourcing Manager (CCOM) reports to the Senior Vice President of Clinical Operations with dotted-line reporting to the Director of Clinical Operations.
- Provides support and expertise in developing effective clinical contractual agreements, budgets, proposals and actively manage clinical contractual obligations.
- Effectively communicates, develops and cultivates operationally excellent internal cross-departmental and external service provider relationships to enable advancement of clinical development programs.
- Negotiates final scopes of work, budget, and payment schedules with input from cross-functional stakeholders for clinical study service providers.
- Negotiates change orders and ensures service providers adhere to contract terms.
- Reviews invoices against vendor contracts to ensure accuracy and service completion.
- Generates Request for Information (RFIs), Request for Proposal (RFPs) and budget grids/trackers for clinical trials, and assist Clinical Operations Management with the service provider selection process including bid comparison analysis.
- Coordinates bid defenses and proposal review meetings.
- Contract lifecycle management.
- Assists Clinical Operations and Finance with month-end and budget/forecasting needs, such as accruals, project budgets, etc.
- Facilitates and executes supplier governance meetings and reviews.
- Measures and reports quarterly service provider performance using metrics and KPIs to ensure compliance against agreed upon expectations such as timeliness, cost and quality.
- Assists Clinical Operations Management with creating clinical trial budgeting models and what-if scenarios.
- Assist with the identification and implementation of clinical contracts systems or processes.
- Assist management with audits of contract and sourcing records to ensure accuracy and completeness.
- Assists in the development, improvement and implementation of processes and tools related to outsourcing activities including a database for identifying and maintaining current and potential service providers.
- Manages contract activities for multiple clinical development programs, completing site and vendor contracts accurately, consistently, and in a timely manner, including the transition of certain activities from Cidara to Clinical Research Organizations (CRO) and management of associated CRO activities.
- With the support of Cidara legal counsel resources, manages the contract negotiation process, especially in more complex, or high value contracts.
- Supports the day-to-day activities of multiple areas in complex clinical contracting processes.
- Supports and manages general and departmental ad hoc projects as required.
- Required BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered.
- 6 years of related experience in a Biotech or Pharmaceutical organization.
- Solid understanding of drug development and clinical operations
- Ability to prepare/negotiate external provider master service agreements, work/change orders, etc. and track for clinical operations.
- Must demonstrate an understanding of clinical site and 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 and Outlook.
- Must be a self-starter who works with minimal supervision.
- Works effectively in a matrix cross-functional environment.
- Good business judgment and a strong understanding of the unique aspects of clinical financials.
- Must have the ability to interact with clinical teams, corporate finance, and IT to provide oversight of clinical payment management activities
- 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 experience in RFI/RFP development, proposal evaluation, preparation/negotiation of clinical contractual agreements, manage contract lifecycle and budget management for assigned clinical project/operations.
The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.
Cidara Therapeutics is an EEO/AA/Disability/Vets Employer and an E-Verify Company