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:

• 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

Data Manager III:

• 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)

Qualifications

Education & Experience

Data Manager II:

• 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

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 (e.g., Medidata Rave, Medrio, Veeva, eCaselink)
• Experience in the data management of all phases of clinical trials

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 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.

Supervisory Responsibilities:

None

Preferred Experience

Data Manager II:

• Prior experience with oncology clinical trials
• Data Manager Certification strongly preferred

Data Manager III:

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