- Reviewing protocols
- Designing Case Report Forms
- Developing edit checks
- Creating and maintaining data management plans
- Testing EDC databases
- Querying clinical sites for data cleaning purposes
- Validating SAS programming against the EDC database
- Collaborating with various departments on the design, documentation, testing and implementation of clinical data studies
- Writing SOPs and contributing to the improvement of Data Management processes
- Maintaining Data Management timelines and metrics
- Manages and performs ongoing data management activities including: clinical data review, query generation, receipt and reconciliation of external data, SAE reconciliation and production of CDM summary reports
- Provides clear verbal or written information and hands-on support in reviewing protocols, developing edit checks, and testing the EDC databases in accordance with Standard Operating Procedures (SOPs).
- Works with clinical study team to generate document(s) to address any issues/errors.
- Conducts training on EDC database
- Manages mid-study changes to the database
- Reviews clinical coding reports
- Creates and maintains required study documentation in preparation for regulatory audits
- Authors 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 department initiatives and process improvements related to SOPs and DM processes
- Provides proactive updates on DM timelines and metrics to the study team and BDMW management
- Represents Clinical Data Management at study team meetings and facilitates cross-functional activities (e.g. Clinical Data Listing Reviews, database lock activities)
- Bachelor's degree in the health sciences disciplines or a related field of study
- A minimum of four (4) years of experience in the data management of clinical trials. If no Bachelor's degree, must have a H/S diploma or equivalent and a minimum of six (6) years of experience in the data management of clinical trials.
- At least two (2) years of experience with EDC technology (ex: RAVE, INFORM)
- Experience in all stages of clinical trials within Data Management
- 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
- 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 (e.g., Medidata Rave, Medrio, Veeva, eCaselink)
- Experience in the data management of all phases of clinical trials
- 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 MSOffice (Word, PowerPoint, Excel) and other relevant software
- Ensures CRO compliance with applicable DM SOPs, safety data standards, and regulatory guidance
- 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.
- 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.
- Prior experience with oncology clinical trials
- Data Manager Certification strongly preferred
- At least 2 years of prior experience acting as a lead data manager in oncology clinical trials
- Data Manager Certification strongly preferred
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Data Manager II/III - Rockville, United States - MacroGenics
Description
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.Our team of350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceuticaland biotechnologycompanies 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 Data Manager II collaborates with various departments on the design, documentation, testing and implementation of clinical data studies. Develops systems for organizing data to analyze, identify and report trends. Analyzes the interrelationships of data and defines logical aspects of datasets. Prepares reports of clinical trial studies for internal validation and cross validation studies. May evaluate and resolve issues regarding contents of reports.
The Data Manager III will assist or serve as the study lead and point of contact for various departments for all aspects of Clinical Data Management and reporting. The DM III is responsible for developing organizational systems for data analysis, identifying and reporting trends, and evaluating and resolving data issues.
Responsibilities and Job Duties:
Data Manager II:
Education & Experience
Data Manager II:
None
Preferred Experience
Data Manager II:
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 or call and/or 711 for TTD/TTY service.
Equal Opportunity Employer/Veterans/Disabled
