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.

The Sr. Clinical Operations Systems Manager is responsible for identification, selection, implementation, validation, maintenance, training and user support for all systems used by the MacroGenics Clinical Operations Department. These systems include but are not limited to Veeva Vault eTMF, CTMS, Medidata’s Grants Manager and Clinical Operations Dashboard. This individual will be the liaison between Information Technology and Clinical Operations and is expected to identify areas where technology can drive process improvement and enhance productivity. This individual will be responsible for building strong relationships across the Clinical Operations Department and other internal and external stakeholders as necessary to identify, communicate and drive value from these systems while ensuring proper training and support are provided to the team.

This position functions on both an operational and strategic level and is responsible for leadership engagement, driving adoption, defining integration strategy and driving operational efficiency. This position will work closely with IT to coordinate and project manage all aspects of life-cycle management. The key responsibility of this position is to ensure that optimal systems are being utilized within Clinical Operations and maximum benefit is being derived. The position will partner with IT to ensure systems are selected, implemented and managed in a manner that is efficient and effective as well as meets key stakeholder requirements. The ultimate goal of this position is to increase productivity, standardization and efficiency in the delivery of clinical trials though the appropriately implemented and supported systems and tools.

Responsibilities and Job Duties:                      

• Manage Clinical Operations technical vendors including but not limited to BioClinica On-Point, Veeva Systems, Medidata and the Clinical Dashboard
• Coordinate validation, maintenance, version updating, training, access privileges management, requirement definitions, system change management, testing and user support for all necessary systems
• Coordinate Clinical Operations systems activities with the MacroGenics IT group.
• Trouble shoot system issues with vendor and internal / external cross functional partners
• Evaluate new technologies and their potential impact on MacroGenics processes and productivity; drive strategic decision making regarding need/selection and prepare business case, as appropriate.
• Write and maintain SOPs, Working Practices and training materials required for all systems being managed
• Drive the use and adoption of technology to ensure compliance with Clinical Operations processes.
• Engage Clinical Operations Department to identify technology needs and build support for the use and adoption of existing and new systems.
• Provide management and operational expertise to drive continuous improvements that align with the objectives and vision of the Clinical Operations organization.
• Establish relationships across all facets of Clinical Development to ensure proper sharing of information and data.
• Establish collaborative relationships with key stakeholders in the organization to drive adoption of new systems, processes, and approaches.

Education & Experience

• Bachelors degree
• Minimum of 8 years of experience with the validation, update, maintenance, and use of clinical systems.
• At least 6 years of experience supporting and interfacing with Clinical Development functions such as Clinical Operations, Clinical Research, Data Management, Biostatistics, Pharmacovigilance and Information Technology

Knowledge, Skills and Abilities

• Strong working knowledge of Clinical Operations processes and requirements
• Strong working knowledge of system selection, validation and maintenance
• Strong vendor management skills
• Project management and team leadership skills
• Proven strong troubleshooting and problem-solving skills.
• Excellent technical writing skills

Supervisory Responsibilities:

None

Preferred Qualifications:

Bachelors degree in Physical, Life or Computer Sciences

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

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