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 studies
• Mentoring more junior data managers
• Interacting with external data vendors and ensuring data received are fit for analysis
• Reviewing protocols
• Designing Case Report Forms
• Developing edit checks
• Creating and maintaining data management plans
• Testing or coordinating the testing of EDC databases
• Querying or managing the querying of clinical sites for data cleaning purposes
• Developing programming specifications for intricate data validation reports.
• Collaborating with various departments on the design, documentation, testing and implementation of clinical data studies
• Writing/Modifying/Enforcing SOPs and contributing to the improvement of Data Management processes
• Maintaining Data Management timelines and metrics
• Keeping abreast of the latest developments in data management processes, software, and applicable regulatory documents

Qualifications            

Principal Data Manager: 

Education & Experience

• Associate’s or Bachelor’s degree in health sciences or related field of study
• A 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 degree
• A minimum of 5 years of EDC technology experience
• A minimum of 4 years of demonstrated oncology experience

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.
• Possesses excellent knowledge of clinical data management processes
• SCDM Data Manager Certification a plus.

Senior Principal Data Manager: 

Education & Experience

• Associate’s or Bachelor’s degree in health sciences or related field of study
• A 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 degree
• A minimum of 7 years of EDC technology experience
• A minimum of 6 years of oncology experience

Knowledge, Skills and Abilities

• Excellent knowledge of clinical data management processes
• SCDM Data Manager Certification or appropriate experience is required

Supervisory Responsibilities

None

Preferred Qualifications

•  BLA or NDA experience preferred

Additional 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.