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RTI International · 3 days ago

Senior Clinical Data Manager

United States

Full-time

Remote

Senior Level, Lead/Staff

$108K/yr - $131K/yr

8+ years exp

RTI International is an independent, scientific research institute dedicated to improving the human condition. The Senior Clinical Data Manager is responsible for overseeing end-to-end data management activities across multiple global clinical trials, ensuring the integrity and accuracy of clinical trial data in compliance with regulatory guidelines.

ConsultingEducationGovernmentNon Profit

Culture & Values

No H1B

U.S. Citizen Only

Responsibilities

Act as the lead data manager and provide the associated expertise for assigned Phase II/III trials, ensuring timely delivery of high-quality, submission-ready data

In collaboration with trial statisticians, provide strategic input into study designs, protocol development, and data collection strategies to optimize trial efficiency and data flow

Ability to oversee and perform work to author, maintain, and implement study-level data management plans (DMPs), CRF/eCRF specifications, edit checks, validation rules, and other key documentation

Drive continuous alignment of data management strategy with overall program milestones and regulatory objectives

Ensure accuracy, consistency, and completeness of trial data through ongoing review, cleaning, and reconciliation (SAE, labs, imaging, biomarkers, PK, PRO/ePRO, etc.)

Lead data review meetings, ensuring timely identification and resolution of discrepancies

Coordinate interim analyses, database snapshots, and final database lock, ensuring data integrity for regulatory filings and publications

Champion and help design and implement risk-based monitoring (RBQM), centralized data review, and technology-enabled approaches to enhance efficiency and reliability of data cleaning

Ability to oversee and perform work involved in adoption of CDISC standards (SDTM/ADaM) in case report form development and dataset creation

Routinely collaborate and liaise with Clinical Operations, Programming, Biostatistics, Medical Monitoring, and Safety throughout trial development, implementation and to ensure alignment of data deliverables with trial and submission objectives

In collaboration with Clinical Operations and Biostatistics, design and develop data driven clinical trial surveillance reports to ensure quality of data at the trial and site level

In collaboration with Clinical Operations and Biostatistics, ensure data collection, completion and cleaning occurs per expected timelines and support escalation and resolution of identified issues

Collaborate with Clinical Operations and Medical Monitors in pharmacovigilance data management and regulatory reporting

Deliver high-quality datasets, listings, and reports to support regulatory submissions (NDA, BLA, MAA) and health authority inspections

Collaborate on clinical study reports (CSRs), publications, and scientific presentations, ensuring data accuracy and consistency

Provide oversight, governance, and quality management of CRO data management deliverables, holding vendors accountable to timelines, budget, and quality

Review and approve vendor data transfer specifications, reconciliation reports, quality metrics, and compliance documentation

Proactively identify and escalate risks, implementing corrective actions to ensure successful partnership and delivery

Qualification

Clinical Data ManagementGCP ComplianceCDISC StandardsEDC PlatformsData IntegrityRegulatory SubmissionsProject ManagementVendor ManagementSASSQLLeadershipProblem-SolvingCommunication

Required

Bachelor's degree in Life Sciences, Computer Science, or a related field and a minimum of 8 years of progressive experience in clinical data management within a biotech, pharmaceutical, or CRO environment for trials conducted under INDs or equivalent experience

Proven track record of leading global Phase II/III clinical trials through development, database lock, and submission

Deep understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements, including expertise in medical coding, CDISC standards (SDTM, ADaM), and associated electronic data submission to regulatory agencies

Proficiency with EDC platforms (e.g., Medidata Rave, DFexplore) and other systems for clinical trials implemented in compliance with appropriate regulations (e.g., 21 CFR Part 11 compliance)

Strong leadership and project management skills, with the ability to manage multiple priorities in fast-paced environments

Exceptional problem-solving and analytical ability, with a focus on data integrity and risk management

Skilled communicator, able to influence and collaborate across cross-functional teams and with external partners

Able to lead meetings with both internal and external collaborators and communicate complex data management concepts to both researchers and lay audiences

Vendor/CRO oversight experience

Demonstrated ability to work independently, exercise judgment, and drive outcomes with minimal supervision

To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status (e.g., H-1B visa status, etc)