Support execution of pharmaceutical-sponsored studies in accordance with approved protocols, SOPs, GCP, and applicable regulatory requirements
Maintain accurate study enrollment records, participant identifiers, and operational logs suitable for sponsor review
Support reconciliation between participant lists and safety, efficacy, and operational data sources
Prepare documentation and data outputs for sponsor monitoring, audits, and inspections
Support maintenance and updates of study-specific SOPs, monitoring plans, and training materials
Ensure study personnel training documentation is complete and audit-ready
Perform source data verification (SDV) and data quality checks consistent with sponsor and CRO expectations
Independently write and review SQL queries to extract, reconcile, and validate study datasets against source systems
Identify data discrepancies, trends, and protocol deviations; document findings and support resolution per established procedures
Partner with Data Analytics to define sponsor-approved monitoring metrics and KPIs (e.g., enrollment, retention, safety signals, deviations)
Contribute to the design, build, validation, and maintenance of study monitoring dashboards used for internal oversight and sponsor reporting
Support ad hoc sponsor data requests and feasibility or exploratory analyses
Prepare study monitoring outputs, reconciliation logs, and SDV summaries for internal and sponsor use
Support interim and final study reports by validating underlying datasets and analyses
Document data review methodologies, assumptions, and validation steps to support traceability and audit readiness
Serve as a liaison between Scientific Affairs, Enterprise Data, and pharmaceutical or CRO partners
Translate sponsor and protocol requirements into data specifications and monitoring logic
Escalate data quality, compliance, or operational risks to study leadership promptly
Contribute to continuous improvement of sponsor-facing monitoring and data oversight processes

Requirements

Bachelor’s degree in health sciences, life sciences, statistics, data science, or a related field, or equivalent experience
5-7 years of experience in clinical research, research operations, or data operations within a pharmaceutical company, contract research organization (CRO), or pharma-sponsored research environment
Hands-on experience supporting sponsor monitoring, SDV, or data reconciliation activities
Strong working knowledge of SQL and experience querying relational databases for study monitoring and validation
Familiarity with GCP, ICH guidelines, and sponsor expectations for data quality and documentation
Strong analytical, documentation, and communication skills
Experience supporting RWE, observational studies, or post-marketing research for pharmaceutical sponsors (preferred)
Experience building or validating dashboards in BI tools (e.g., Hex) (preferred)
Experience working with safety data, lab data, EHR-derived data, or patient-reported outcomes (preferred)
Prior experience interacting directly with sponsors, CROs, or monitors during audits or data reviews (preferred)
Completion of required GCP and human subjects protection training prior to study involvement, with re-certification as required

Benefits

Full medical, dental, and vision insurance + OneMedical membership
Healthcare and Dependent Care FSA
401(k) with company match
Flexible PTO
Wellbeing + Learning & Growth reimbursements
Paid parental leave + Fertility benefits
Pet insurance
Student loan refinancing
Virtual resources for mindfulness, counseling, and fitness

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

SQLdata reconciliationsource data verificationdata quality checksdata validationdata extractiondata analysismonitoring metricsKPI definitiondashboard design

Soft Skills

analytical skillsdocumentation skillscommunication skillsproblem-solvingattention to detailorganizational skillscollaborationindependenceadaptabilitycontinuous improvement

Certifications

GCP certificationhuman subjects protection training