Manager Clinical Research - Pediatrics - MCW CSG Shared Services

The Medical College of Wisconsin, Inc.; Wauwatosa (WI); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Health coverage and benefits

Flexible Spending options (403B)

Tuition reimbursement

Job summary

The Medical College of Wisconsin (MCW) seeks a Clinical Research Manager to lead a diverse pediatric clinical research portfolio within DASH. You will oversee budgeting, contracts, IRB processes, and regulatory compliance while guiding a multidisciplinary team of research staff and coordinators.

This role partners with faculty to translate priorities into operational plans and scalable processes. Responsibilities include data system management, quality control, and cross-department collaboration

Qualifications

• Bachelor's degree required; minimum 6 years of clinical research experience.
• CCRC or CCRP certification preferred; CITI training within 90 days of hire.

Responsibilities

• Lead pre-trial functions including budget development and contract negotiations.
• Advise investigators on regulatory aspects of human subjects research.
• Develop and implement department policies and tools to ensure compliance with MCW and regulatory standards.
• Manage data systems supporting research activities and data use agreements.
• Recruit, train, and mentor clinical research staff and coordinators; monitor workload and performance.
• Collaborate with biostatistical and analytics teams to prioritize projects and allocate resources.
• Coordinate with other departments and external agencies to advance research goals.

Skills

Budget development

IRB applications

Contract negotiations

Regulatory compliance

Staff mentorship

Data management and analytics

Education

Bachelor's degree

Tools

Data management software

Job description

Summary Provide strategic and operational leadership for DASH's diverse pediatric clinical research portfolio, spanning Diagnostics, Anesthesiology, Surgical Specialties, and other related clinical specialties. This position leads a multidisciplinary team of clinical research staff and serves as a key operational partner to faculty across the portfolio. The Clinical Research Manager translates faculty research priorities into effective operational plans, aligns people and resources to study needs, and builds the processes and infrastructure necessary to launch, execute, and grow high-quality clinical research across a complex and varied portfolio.

Primary Responsibilities

Act as a resource for investigators and support staff on pre-trial functions including budget development, contract negotiations and IRB applications. Advise department study investigators and support staff on administrative and regulatory aspects of human subject research. Develop and implement department policies, procedures, and organizational tools to ensure compliance with MCW, state, and federal standards. Manage data systems supporting research activities including aspects of data access, data storage, and data use agreements. Correspond with IRBs and biostatistical support as needed. Assist in the development and management of the budget. Recruit and train clinical research staff and clinical research coordinators; develop and implement standardized expectations for all subordinates; assess, monitor, and evaluate workload and performance. Mentor and direct staff to achieve research goals. Work with biostatistical and data analytics team members to assess project prioritization, workload, and resource allocation Act as a liaison between Department Administrator and research staff. Work closely with other departments and external agencies to advance the department’s research goals. Develop, implement, and monitor department research QI activities. Implement and conduct quality control processes to ensure the highest data and research standards. Develop a clinical review data review plan and check specifications. Utilize quality improvement tools & statistical process control to facilitate improvement of systems & processes. Perform as a study coordinator for select projects. Collaborate with research leadership in formulating workflows between DASH and broader CSG research infrastructure Report out progress on various initiatives within DASH and report research productivity to divisional and departmental leadership Other duties as assigned.

Knowledge – Skills – Abilities

Knowledge of biology, chemistry, mathematics, documentation, and records management. Data utilization, complex problem solving, critical thinking, resource management, and writing skills.

Qualifications

Appropriate experience may be substituted for education on an equivalent basis. Minimum Required Education: Bachelor's degree Minimum Required Experience: 6 years Required Certification/Licensure(s): CCRC or CCRP required. 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

Values

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.

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.

About Us

Together, we can build a healthier world. A student, an educator, a scientist and a community leader — alone, they can do many things. Together, the question isn’t what they can do, but what can’t they. The Medical College of Wisconsin (MCW) brings together the most inquisitive, passionate minds in science, medicine, education and community engagement to tackle today’s toughest challenges in health and society. Academic medicine is at the center of where scientists, physicians and students work hand-in-hand with the community to ask the most important questions and fuel the cycle of innovation that shapes the future of medicine. Medical College of Wisconsin The tireless pursuit of knowledge and the power of academic medicine is at the core of everything we do at MCW. Bringing together the world’s top scientists and clinicians, inspired students and invested communities, we are driven to solve the most complex challenges in health and society. With around 1,600 full-time and part-time faculty and approximately 3,500 full-time employees, MCW is home to a diverse group of thought leaders working in collaboration to pioneer pathways to a healthier …