Principal Data Manager / Senior Principal Data Manager

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 Principal Data Manager / Senior Principal Data Manager collaborates with various departments on the design, documentation, testing and implementation of clinical data studies. Ensures the clinical data are fit for analysis. Provides expertise in all areas of data management to other functions and more junior data management staff. Organizes data to analyze, identify and report trends. Prepares specifications for data validation of clinical trial studies. Evaluates and resolves issues regarding database, data availability and quality, workflow, timelines, and adherence to regulatory guidance and rules.Responsibilities and Job Duties : Providing Data Management leadership on at least two studiesMentoring more junior data managersInteracting with external data vendors and ensuring data received are fit for analysisReviewing protocolsDesigning Case Report FormsDeveloping edit checksCreating and maintaining data management plansTesting or coordinating the testing of EDC databasesQuerying or managing the querying of clinical sites for data cleaning purposesDeveloping programming specifications for intricate data validation reports.Collaborating with various departments on the design, documentation, testing and implementation of clinical data studiesWriting / Modifying / Enforcing SOPs and contributing to the improvement of Data Management processesMaintaining Data Management timelines and metricsKeeping abreast of the latest developments in data management processes, software, and applicable regulatory documentsQualifications Principal Data Manager : Education & Experience Associate’s or Bachelor’s degree in health sciences or related field of studyA minimum of 13 years of clinical data management experience with a Bachelor’s degree or a minimum of 15 years of clinical data experience with an Associate’s degreeA minimum of 5 years of EDC technology experienceA minimum of 4 years of demonstrated oncology experienceKnowledge, Skills and Abilities Knowledge of the clinical trial process and how data management supports that processCurrent understanding of GCP and regulatory requirements as they relate to data management systems and activities; demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)Ability to work independently and collaboratively in a team-based environmentMust be proficient in MSOffice (Word, PowerPoint, Excel) and other relevant softwareEnsures CRO compliance with applicable DM SOPs, safety data standards, and regulatory guidanceAble to effectively manage multiple assignments and adapt flexibly to changing priorities.Able to produce robust timelines and action plans, regularly review and follow up on progress and take decisive action in terms of follow up activities with local and global trial / project teams.Ensures work is completed effectively.Ensures all tasks are carried out in accordance with respective applicable MacroGenics’ Standard Operating Procedures (SOPs), regulatory guidelines and working instructions.Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with MacroGenics’ Living Values.Possesses excellent knowledge of clinical data management processesSCDM Data Manager Certification a plus.Senior Principal Data Manager : Education & Experience Associate’s or Bachelor’s degree in health sciences or related field of studyA minimum of 15 years of experience in clinical data management with a Bachelor’s degree or a minimum of 17 years of clinical data experience with an Associate’s degreeA minimum of 7 years of EDC technology experienceA minimum of 6 years of oncology experienceKnowledge, Skills and Abilities Excellent knowledge of clinical data management processesSCDM Data Manager Certification or appropriate experience is requiredSupervisory Responsibilities NonePreferred Qualifications BLA or NDA experience preferredAdditional Information The annual rate of pay for this position ranges from $115,400 to $179,000 (Principal Data Manager) and $125,600 to $194,800 (Sr. Principal Data Manager). For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company’s discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company’s benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits.The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.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 / DisabledWe do not accept non-solicited resumes or candidate submittals from search / recruiting agencies.#J-18808-Ljbffr

Salary : $125,600 - $194,800