The Manager of Clinical Operations (Finance) is accountable for successful execution of business operations processes within the Clinical Operations department including, but not limited to, proposal budget review and negotiation, oversight of contract and budget development for new projects, management of contract amendments, and budget forecasting. Proactively identifies and resolves business operations issues and participates in process development and improvement initiatives as required.
Major Duties/Responsibilities
1. Assists the Director of Clinical Operations (Finance) with the financial management of business operations within the Clinical Operations department to meet department and company-level goals.
2. Provides timely and accurate input to clinical development plans including forecasting of timelines, estimation of resources, and program level budget.
3. Assists Clinical Trial Managers with preparation of Requests-for-Proposal (RFPs) to support vendor selection for new project efforts within Clinical Operations.
4. Develops contract text and budget through negotiation with Clinical Operations vendors for new contracts and contract amendments.
5. Identifies contractual and financial risks to clinical development projects; proactively creates and manages mitigation strategies.
6. Maintains active collaboration with Clinical Trial Mangers regarding the status of their contracts.
7. Maintains project-level budget forecasting tools. Assists Director of Clinical Operations (Finance) with department-level budget forecast input to Corporate Finance.
8. Initiates frequent cross-functional interactions with internal and external personnel (e.g. Accounting, Finance, Quality Assurance, Vendors) and collaborates effectively to achieve desired outcomes.
9. Ensures all aspects of responsibilities are executed in compliance with international GCP guidelines and regulations and company SOPs; Ensures audit-ready condition of clinical trial documentation;
10. Requires excellent communication and organizational skills, along with a strong attention to detail, problem solving, conflict resolution, and collaboration skills.
Physical Demands
The physical demands of the office are normally associated with extended amounts of time in front of a computer. While performing the duties of this job, the employee is frequently required to stand, walk, and sit.
Travel may be required (up to 10%)
Education & Professional Experience
Required:
Bachelor’s degree or equivalent combination of education/experience in business administration, finance, science or health-related field required
Minimum of 5 years of clinical trial exposure in Pharmaceutical, Biotech or CRO company required
Strong understanding of GCP, ICH, and knowledge of regulatory requirements
Preferred:
Advanced degree in science or business
Experience with clinical research site and/or vendor contract development
Experience with development and review of budgets for clinical trial activities
Oncology experience