Senior Clinical Data Manager

RTI International is an independent, scientific research institute dedicated to improving the human condition. Our vision is to address the world's most critical problems with technical and science-based solutions in pursuit of a better future. Clients rely on us to answer questions that demand an objective and multidisciplinary approach-one that integrates expertise across social, statistical, data, and laboratory sciences, engineering, and other technical disciplines to solve the world's most challenging problems.

We believe in the promise of science and technical solutions, and we push ourselves every day to deliver on that promise for the good of people, communities, and businesses in the US and around the world. If you are looking for the opportunity to make a real difference, RTI is the place for you.

The Senior Clinical Data Manager (Sr. CDM) is a strategic and hands-on leader responsible for overseeing end-to-end data management activities across multiple global clinical trials. This role ensures the integrity, accuracy, and completeness of clinical trial data in compliance with Good Clinical Practice (GCP), regulatory guidelines, and company standard operating procedures (SOPs). The Sr. CDM serves as the primary liaison between internal teams, contract research organizations (CROs)/external vendors, providing oversight, guidance, and innovation in all aspects of data management. With deep expertise in data systems and standards, this role plays a critical part in accelerating timelines, supporting regulatory submissions, and driving the overall success of clinical development programs.

Key Responsibilities

Study Leadership & Strategy

• 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.

Data Quality, Oversight & Delivery

• 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.

Cross-Functional & Regulatory Support

• 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.

CRO & Vendor Management

• 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.

Education & Experience

• Bachelor's degree in Life Sciences, Computer Science, or a related field and minimum 12 years of progressive experience in clinical data management within a biotech, pharmaceutical, or CRO environment for trials conducted under INDs or equivalent experience. Equivalent experience is a and 10 years of experience. Master's degree preferred.
• 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.
• Vendor/CRO oversight experience.
• Technical proficiency in SAS, SQL, or other data programming languages highly desirable.
• 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).

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For San Francisco, CA USA Job Postings Only: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Further information is available here.

RTI accepts applications to our job openings from candidates with criminal histories or conviction records in accordance with all applicable laws, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

For Applicants in Massachusetts Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

The anticipated pay range for this role is listed below. Our pay ranges represent national averages and may vary by location as a geographic differential may be applied to some locations within the United States. RTI considers multiple factors when making an offer including, for example: established salary range, internal budget, business needs, and education and years of work experience possessed by the applicant. Further, salary is merely one element to our offer.

At RTI, we demonstrate our commitment to rewarding individual and team achievement through a total rewards package. This package includes (among other things) a competitive base salary, a generous paid time off policy, merit based annual increases, bonus opportunities and a robust recognition program. Other benefits include a competitive range of insurance plans (including health, dental, life, and short-term and long-term disability), access to a retirement savings program such as a 401(k) plan, paid parental leave for all parents, financial assistance with adoption expenses or infertility treatments, financial reimbursement for education and developmental opportunities, an employee assistance program, and numerous other offerings to support a healthy work-life balance.