The Clinical Outsourcing & Budget Manager will work closely with Clinical Operations, Legal, and Finance departments, as well as additional internal/external parties as needed. This individual is responsible for the timely preparation, negotiation, and administration of clinical trial vendor contracts and accruals to ensure cost effective and accurate contracting services between MacroGenics and its vendors.
Responsibilities and Job Duties
Manage contracts by interacting regularly with the Clinical Team and assessing when new contracts and/or change orders are needed.
With Legal, review and negotiate standard to moderately complex agreements, including confidential disclosure agreements, clinical trial agreements (CTA), vendor work orders and other contracts relating to clinical trials.
Assist with the development of standardized, study-specific budgets to be included with CTA contract templates.
Work independently to facilitate resolution of routine contract and invoicing issues within clinical trial agreements, consulting agreements, service agreements, and others as needed.
Manage and track accruals and invoicing by obtaining monthly information from vendors and the clinical study team, as well as interact with Finance as needed and respond to any inquiries.
Manage accrual forecasting and provide updates to Finance.
Act as liaison among internal clients, external vendors/business partners to facilitate and engage in contract preparation, negotiation, and administration
Utilize and maintain tracking and database systems for contracts
Minimum of 5 years of experience required in clinical trial contracting, with CRO and other associated vendor costing/management experience.
Minimum of 5 years working with accruals and financial forecasting.
Knowledge, Skills and Abilities
Proven track record of successfully negotiating multiple site and/or vendor contracts across multiple clinical trials
Understanding of clinical trial operations
Excellent negotiation skills
Strong analytical and problem-solving skills
Individual must possess the ability to influence without direct authority
Must be organized and possess ability to handle multiple priorities in a fast-paced environment
Must possess excellent written and verbal communications skills.
Must be proficient in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet)
Familiarity with GCP/ICH guidelines
Internal Number: 2018-1173
About MacroGenics, Inc.
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.