Clinical Systems Manager, Clinical Data Management

Regulatory Jobs; Boston (MA); Hybrid; USD 120,000 - 145,000; Full time

Benefits offered by this job

Unlimited PTO

Lifestyle spending account

Commuting reimbursement

Job summary

Rapport Therapeutics seeks a Clinical Systems Manager to oversee the deployment, security, and optimization of clinical information systems supporting SAFE, efficient, compliant trials.

You will partner with clinicians, IT, and vendors to ensure reliable interfaces, data integrity, and regulatory readiness while advancing the company’s RAP programs.

Qualifications

• Bachelor's degree in a relevant field.
• 4 to 7 years in healthcare, clinical development, or IT data management, including 2+ years in a leadership or system ownership role.
• Proficiency with EHR systems, database structures (SQL), SAS, cloud environments (AWS/GCP), and data integration standards.
• Familiarity with CDASH, SDTM, data quality standards and submission requirements.
• Strong analytical, organizational, and problem-solving skills with attention to detail.
• Excellent communication and leadership skills with the ability to influence across functions and levels.

Responsibilities

• Oversee implementation, maintenance, optimization, and security of clinical information systems.
• Serve as the primary liaison between clinical end-users and IT/software vendors.
• Manage data interfaces (HL7/FHIR, lab/radiology connections) to ensure accurate data flow.
• Maintain compliance with HIPAA, GCP, 21 CFR Part 11 and privacy laws.
• Coordinate testing, SOPs, and staff training on system usage.
• Oversee third-party vendors, track milestones, and manage system changes.
• Collaborate across Data Management, Biostatistics, Programming, Clinical Operations and Finance.

Skills

Leadership

Communication

Analytical thinking

Problem-solving

Cross-functional collaboration

Education

Bachelor's degree in Computer Science, Information Systems, Nursing, Life Sciences, or a related field

Tools

SQL

SAS

Cloud platforms (AWS/GCP)

CDASH/SDTM

Job description

When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we’re driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we’re doing this with extraordinary science and awesome people (affectionately called Rapptors).

Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials in primary generalized tonic-clonic seizures (PGTCS) and bipolar disorder.

The strength of Rapport comes from our Rapptors – who are united by our mission to improve patients lives. We bring the heart and hustle to advance our science forward, always staying true to our core values. We hope you’re as excited about this opportunity as we are!

Your impact:

As Clinical Systems Manager you will oversee the implementation, maintenance, optimization, and security of clinical information systems (such as EDC, Data Warehousing and Reporting Tools, IRT, or eCOA) to ensure they support safe, efficient, and compliant clinical research.

Your day-to-day:

• System Administration: Manage the deployment, daily operations, upgrades, and configuration of clinical platforms.
• Cross-Functional Liaison: Serve as the primary bridge between clinical end-users (doctors, nurses, researchers) and IT or software development vendors.
• Integration & Data Flow: Oversee system interfaces (such as HL7/FHIR or lab/radiology connections) to ensure data moves accurately between platforms.
• Compliance & Validation: Maintain adherence to regulatory standards like HIPAA, GCP, 21 CFR Part 11, and data privacy rules.
• User Training & Support: Coordinate testing, write Standard Operating Procedures (SOPs), and guide staff on proper system usage.
• Vendor & Project Management: Oversee third-party software providers, track project milestones, and manage system changes.
• Serve as a trusted business partner across Data Management, Biostatistics, Programming, Clinical Operations, Finance, and Clinical Development, fostering cross-functional collaboration and continuous improvement.

Must-Haves:

• Bachelor's degree in Computer Science, Information Systems, Nursing, Life Sciences, or a related field.
• 4 to 7 years of combined experience in healthcare, clinical development, or IT data management, including 2+ years in a leadership or system ownership role.
• Proficiency with Electronic Health Record (EHR) systems, database structures (SQL), SAS, cloud environments (AWS/GCP), and data integration standards. CDASH, SDTM, data quality standards and submission requirements
• Strong analytical, organizational, and problem-solving skills with attention to detail.
• Excellent communication and leadership skills with the ability to influence across functions and levels.

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this? We tell you about our hiring range now - we expect the hiring range for the role to be $120,000 to $145,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company.

Hybrid Work Environment:

We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday-Wednesday to create more opportunities for innovation, collaboration, and connection.

Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

CCPA disclosure notice can be found here.