Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines, including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research, development, and commercial capability and infrastructure, we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria, breast cancer and other solid tumors.

Job Title: Clinical Systems Manager, Clinical Business Operations
Location: Blueprint Medicines, Cambridge, MA

About Us
Blueprint Medicines is a precision therapy company focused on genomically defined cancers, rare diseases, and cancer immunotherapy. We are committed to transforming the lives of patients with complex diseases through our innovative medicines. Our team, known as the Blue Crew, embodies our core values of Patients First, Trust, Optimism, Thoughtfulness, and Urgency in everything we do.

Job Summary

As a Manager in Clinical Systems, you will be part of a team to help support the day-to-day management of clinical systems to support clinical trial operations and regulatory compliance. You’ll be within a dynamic cross functional team and help to support our planning, implementation and user adoption efforts for technologies that enable us to work more efficiently within Blueprint. This position is ideal for a professional who has experience within Clinical Operations, Data Management, Clinical Science, or Quality. We believe that it is a person who has mastered their role and wants to take their career in a new direction. The candidate must have an affinity for technology as this role requires you to know the assigned systems well so you can best support end users (the clinical trial teams). The role requires a customer service-minded individual who can train to all levels. No day will be alike! On one day you may be head down reviewing specifications and the next day you may be big picture planning with us.

Key Responsibilities

• Oversee daily operations of clinical systems to support trial management teams, focusing on the clinical data warehouse and IRT/RTSM systems.
• Act as a business administrator for various clinical systems, including IRT, TMF, and the Clinical Data Warehouse.
• Collaborate with Quality and IT teams to manage Change Control processes and execute User Acceptance Testing.
• Ensure data accuracy and integrity as a data steward for clinical systems.
• Serve as a liaison between Clinical Users/Study Teams and IT, facilitating communication and managing expectations during technology changes.
• Work with clinical stakeholders to understand their needs and provide user training and support, including creating training materials.
• Facilitate integration of clinical systems with other IT solutions to meet organizational needs.
• Coordinate with IT, QA, and Clinical Development teams to implement new systems and upgrades, ensuring smooth transitions.
• Act as the point of contact for stakeholders regarding clinical system functionalities and improvements.
• Assist in documentation and compliance activities to meet regulatory standards.

Qualifications

• Bachelor’s degree in life sciences, computer science, business administration, or a related field.
• At least 3-5 years of experience in clinical systems, clinical operations (or similar role) within the pharmaceutical industry, with a track record of successful project management.
• Strong understanding of clinical operations and IT infrastructure.
• Effective leadership and communication skills, with the ability to manage cross-functional teams and projects.
• Familiarity with clinical trial management systems and regulatory compliance requirements.
• Proactive and analytical mindset with excellent problem-solving capabilities.

Core Competencies

• Operational Excellence: Demonstrates the ability to efficiently manage daily operations of clinical systems, ensuring smooth and effective functioning that supports clinical trial activities and compliance requirements.
• Team Leadership and Development: Possesses leadership qualities that inspire and motivate team members. Capable of managing a diverse team, providing guidance, and promoting professional growth and development within the team.
• Technical Knowledge and Application: Has a solid understanding of clinical systems technologies and how they integrate with other IT resources to support clinical operations. Skilled in troubleshooting, system enhancements, and ensuring operational stability.
• Problem Solving and Critical Thinking: Utilizes a systematic approach to solving problems and making decisions. Capable of identifying issues, analyzing potential solutions, and implementing effective resolutions.
• Communication Skills: Communicates effectively across all levels of the organization. Able to clearly convey technical information to non-technical stakeholders and facilitate collaboration between various departments.
• Project Management: Exhibits strong organizational and project management skills. Can oversee projects from inception to completion, ensuring they meet deadlines, stay within budget, and achieve desired outcomes.
• Regulatory and Compliance Awareness: Understands the regulatory environment relevant to clinical systems in the pharmaceutical industry. Ensures systems and processes comply with all applicable regulations and standards.

Pay Transparency:

The pay range that Magnit reasonably expects to pay for this position: $50.00 - 60.00 /hour.

Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met).

Why Blueprint?

At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators – the Blue Crew. Through authentic relationships and our collective entrepreneurial spirit and action, we are each empowered to take ownership and execute with strategic prioritization. We put trust in our people to break through norms and conventions using their individual strengths and insights, which drives our success.

This is the place where the extraordinary becomes reality, and you could be part of it.

Patients are waiting. Are you ready to make the leap?

Equity, Diversity, Inclusion and Affirmative Action

At Blueprint Medicines, we foster a culture of equity, diversity, and inclusion.  A proud Equal Employment Opportunity and Affirmative Action employer, we consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law.  We are also an E-Verify Employer.  We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability in need of accommodation with the application or recruiting process, please reach out to TotalRewards@blueprintmedicines.com. 

For more information, please see our EEO-AA Policy Statement, the EEO Know Your Rights Poster, as well as our Pay Transparency Statement. 

Job Location: Cambridge, Massachusetts (Hybrid)

Contract Duration: 6 months

• Work Authorization : Green Card, US Citizen
• Preferred years of experience : 3-5 Years
• Travel Required : No travel required
• Shift timings: Not specified