Senior Data Manager/Data Manager III

Location: Remote, CA (97458)
Company: MacroGenics, Inc.
Industry: IT
Job Type: Full Time
Posted: 5 days ago

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.? Our team of 400+ 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 Senior Data Manager/Data Manager III (DM) will assist or serve as the DM study lead and point of contact for various departments for all aspects of clinical database design and reporting. This individual is responsible for developing organizational systems for data analysis, identifying and reporting trends, evaluating and resolving data issues and mentoring less experienced DMs/Data Coordinators. This individual will lead all aspects of the clinical trial data management process from pre-study start up to post database lock for assigned projects.

Responsibilities and Job Duties

  • Manages and performs ongoing data management activities including: clinical data review, query generation, receipt and reconciliation of external data, SAE reconciliation and production of DM summary reports
  • Provides clear verbal or written information and hands-on support in reviewing protocols, developing edit checks, and testing the EDC databases
  • Conducts training on EDC database
  • Manages mid-study changes to the database
  • Reviews clinical coding reports
  • Interacts independently and effectively with all cross-functional team members
  • Keeps abreast of the latest processes and technologies in the Biopharmaceutical industry and evaluates their potential impact on MacroGenics BDM processes and productivity and provides recommendations to the VP of BDM
  • Creates and maintains required study documentation in preparation for regulatory audits
  • Authors, QCs and maintains Data Management Plans, Data Transfer Agreements and other DM documents
  • Oversees the DM portion of integration between EDC and other systems
  • Ensures CRO compliance with applicable DM SOPs, safety data standards, and regulatory guidance
  • Assists with and monitors compliance with department initiatives and process improvements related to SOPs and DM processes
  • Provides proactive updates on DM timelines and metrics to the study team and BDM management
  • Represents Clinical Data Management at study team meetings and facilitates cross-functional activities (eg Clinical Data Listing Reviews, database lock activities)
  • Mentors less experienced Data Managers/Coordinators

Minimum Qualifications

Education & Experience

Sr. Data Manager

  • Bachelor's degree in the health sciences disciplines or related field of study and a minimum of 9 years of experience in the data management of clinical trials

OR

  • Associate's degree in the health sciences disciplines or related field of study and a minimum of 11 years of experience in the data management of clinical trials
  • At least 6 years of experience with EDC technology (eg, Medidata Rave, Medrio, Veeva, eCaselink)
  • Experience in the data management of all phases of clinical trials is desired

Data Manager III

  • Bachelor's degree in the health sciences disciplines or related field of study and a minimum of 6 years of experience in the data management of clinical trials

OR

  • Associate's degree in the health sciences disciplines or related field of study and a minimum of 8 years of experience in the data management of clinical trials
  • At least 4 years of experience with EDC technology (eg, Medidata Rave, Medrio, Veeva, eCaselink)
  • Experience in the data management of all phases of clinical trials is desired

Knowledge, Skills and Abilities

  • Knowledge of the clinical trial process and how data management supports that process
  • Current 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 environment
  • Must be proficient in MS Office (Word, PowerPoint, Excel) and other relevant software
  • Able 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.
  • Seeks Data Management advice from Manager infrequently
  • Ensures all tasks are carried out in accordance with respective applicable MacroGenics' 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.

Supervisory Responsibilities

None

Preferred Experience

  • At least 2 years of prior experience acting as a lead data manager in oncology clinical trials
  • Data Manager Certification strongly preferred

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.

Equal Opportunity Employer/Veterans/Disabled

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

To promote the health and well-being of our employees and ensure business continuity, MacroGenics requires all new hires to be fully vaccinated for COVID-19 by his/her start date. A new hire will need to either (a) establish that they have been fully vaccinated or (b) obtain an approved exemption as an accommodation.



Web Reference : AJF/358528524-202
Posted Date : Thu, 30 Jun 2022

Please note, to apply for this position you will complete an application form on another website provided by or on behalf of MacroGenics, Inc.. Any external website and application process is not under the control or responsibility of IT JobServe

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