MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 350 dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology 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.

Summary of Position 

The Clinical Systems Analyst/Senior Clinical Systems Analyst performs eTMF system administrator duties and is responsible to ensure that the MacroGenics eTMF is maintained, upgraded and appropriately configured. The incumbent will provide first level support for MacroGenics eTMF users and ensure users have the appropriate access. With oversight from the Associate Director, develops and provides appropriate training and support. Assists in evaluating, prioritizing and managing changes to the eTMF system. In addition, this role will be responsible for the day-to-day support and daily operations of the MacroGenics Veeva eTMF system. They will be required to collaborate with third party vendors.

Responsibilities and Job Duties

User Access and Management

• Onboard/offboard MacroGenics’ system users in a timely manner to ensure continuity of use.
• Develop materials and train and support MacroGenics’ system users
• Provide eTMF guidance to the end users for the full life cycle of each study
• Meet regularly with MacroGenics’ users to assess additional requirements and features required by the business

Study Setup, Management, and Closure

• Ensure eTMFs are built according to the specific study architecture for inputs, including country and site objects; vendor and account objects; study team assignments; baseline milestones and baseline expected documents lists.
• Maintain study team assignments in the eTMF.
• Ensures MacroGenics cross-functional eTMF business process and operating model is followed for each study and determine differences from standard eTMF structure is documented.
• Provides cross-functional TMF oversight through the study life cycle.
• Provide eTMF guidance to the end users for the full life cycle of each study.
• Creates, maintains and improves key eTMF heath metrics reports within the eTMF system reporting module.
• With oversight, close studies and manage final study reconciliation across all study partners and systems integrations.
• With oversight, manage transfer, migration, and final archive per study.

System Changes

• Working with the business, analyze system requirements and address any relevant problems such as gaps in functionality.
• With direction, perform routine system maintenance, upgrades, and configuration control, aligned with eTMF vendor scheduled updates.
• Support system enhancements and new implementations, including testing, validation, end-user training and post go-live support.
• Validate system changes by testing system operations or functions.
• Leads assigned projects related to eTMF system updates, change controls and improvements.
• Collaborate with the MacroGenics IT team and developers to evaluate new systems, as identified by Senior Clinical Operations leaders
• Ensure that timelines for systems operations are met

System Support

• Troubleshoot, diagnose and solve issues that end users are experiencing with the eTMF system.
• Ensure timely and high-quality incident resolutions focused on knowledge sharing and end-user enablement.
• Escalate issues appropriately to external vendor.
• Meet regularly with MacroGenics’ users to assess additional requirements and features required by the business.
• Document any interfaces between new and legacy systems.
• Maintain system governance plan and operational SOPs in accordance with corporate policies.
• Contribute to budget planning
• Stay up to date with current technologies and technical developments in the clinical trials’ space

Minimum Qualifications

Education & Other Credentials

• Bachelor’s degree, in a Computer Science discipline, Information Technology/Management Information Systems or similar field of study

Clinical Systems Analyst

Experience

• Minimum 3 years proven work experience as a system analyst
• Experience using, testing and training on Veeva eTMF. Experience in a similar eTMF system may be acceptable.
• Experience with Veeva eTMF or other similar eTMF systems.
• Experience at a pharma or biotech company or a CRO in a similar role
• Experience applying change management across systems development and maintenance

Sr. Clinical Systems Analyst

Experience

• Minimum 5 years proven work experience as a system analyst
• Experience using, testing and training on Veeva eTMF. Experience in a similar eTMF system may be acceptable.
• Experience with Veeva eTMF or other similar eTMF systems.
• Experience at a pharma or biotech company or a CRO in a similar role
• Experience applying change management across systems development and maintenance

Knowledge, Skills and Abilities

• Excellent analytical and trouble shooting skills, being solutions oriented
• Excellent verbal and written communication skills
• Strong listening and interpersonal skills – customer service focus
• Ability to work effectively within a team and build strong working relationships at multiple levels within the organization
• Strong organizational skills, attention to detail and task follow-up skills in a fast paced and changing environment, adept at handling multiple work items in a timely manner
• Knowledge of Computer Systems Validation or equivalent best practices and of change control as it relates to application systems
• Strong knowledge and competence in MS Office Tools
• Solid knowledge of information systems
• Ability to explain technical details and complex systems and data models to Users and stakeholders

Supervisory Responsibilities

None

Statement

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

We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.