Summary 

Under the supervision of the Studies Manager and Lead, ensures high quality clinical data are available for regulatory submissions, safety monitoring, contracted deliverables, and publications. Serves as a liaison to respond to and engage network centers in accurate and timely data submission to Center for Blood & Marrow Transplant Research (CIBMTR). 

Primary Responsibilities  

Protocol and Site Management

• Maintains Data Operations educational guides/manuals, reports, and files for assigned studies.
• Assists training study centers.
• Maintain Data Operations assigned study timelines.
• Maintain and monitor assigned study accruals to ensure enrollment goals are met.
• Assists with study related problem-solving activities at enrolled centers.

Data Management

• Assists on the development and collection of study data through comprehensive databases and forms.
• Assist the Research Program Coordinator III and Studies Manager in performing high-quality validation of new datasets.
• With oversight, perform high-quality analysis of study data.
• Generates queries to member centers, resolve data issues, and ensure data quality checks are accurate to established business and clinical requirements.
• Prepare analyzed data in a suitable format for Data Operation deliverables.
• Report study data and progress to Data Operations Studies Manager, program stakeholders, PI’s and CIBMTR scientific directors.

Other Duties

• Communicate with peers, study teams, and management as appropriate to support studies and goals.
• Participate in appropriate committees relevant to the advancement of the corporate program and the profession.
• Assist in training of Data Operations study staff.
• Other duties as assigned.

Knowledge – Skills – Abilities 

Knowledge of quality assurance, technical, business, consultation, project management, and cultural awareness.

Customer focus, building trust, communication, critical thinking, and influencing skills. Organization, time management, interpersonal, communication, and problem-solving skills. Strong computer skills. Highly skilled with MS Office, especially Excel. Understands databases; good technical skills in querying and analyzing data. Manage multiple deadlines and priorities while ensuring quality and timeliness.

Qualifications 

Appropriate experience may be substituted for education on an equivalent basis.

Minimum Required Education: Bachelor’s degree 

Minimum Required Experience:  3 years 

Preferred Education: Bachelor’s degree, preferred in a healthcare or science related field                  

Preferred Experience:  relevant experience in data analysis, data management, project management in a clinical research environment                 

Required Certification/Licensure(s):    CITI training required within 90 days of hire.

Physical Requirements 

Work requires occasionally lifting moderate weight materials, standing, or walking continuously. 

Work Environment

Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment. 

Sensory Acuity 

Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects. 

Why MCW?

• Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
• 403B Retirement Package
• Competitive Vacation and Paid Holidays offered
• Tuition Reimbursement
• Paid Parental Leave
• Employee & Family Assistance Program (EFAP)
• Pet Insurance
• On campus Fitness Facility, offering onsite classes
• Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.

For a brief overview of our benefits see: Benefits Overview

For a full list of positions see: MCW Careers

At MCW all of our endeavors, from our internal operations to our interactions with our partners, are driven by our shared organizational values: Caring – Collaborative – Curiosity – Inclusive – Integrity – Respect. We are committed to fostering an inclusive environment that values diversity in backgrounds, experiences, and perspectives through merit-based processes and in alignment with all applicable laws. We believe that embracing human differences is critical to realize our vision of a healthier world, and we recognize that a healthy and thriving community starts from within. Our values define who we are, what we stand for and how we conduct ourselves at MCW. If you believe in embracing individuality and working together according to these principles to improve health for all, then MCW is the place for you. For more information, please visit our institutional website.

MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination:

The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering an inclusive community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.