- Experiência
- 2–5 anos
- Salário
- USD 70,000 – USD 110,000 / year
- Vagas
- 1
- Publicado
- há 4 horas
- Modo de trabalho
- No escritório
- Educação
- BA/BS degree
- Retomar
- Obrigatório candidatar-se
Descrição da vaga
About Rho
Join a distinctive Contract Research Organization (CRO) where innovation thrives and collaboration is foundational. At Rho, we embrace curiosity and original thinking, fostering a welcoming environment filled with passionate science enthusiasts who value teamwork and creativity.
Be part of a dynamic and stable company offering a secure setting for professional growth and long-term career development.
Role Overview
As a Clinical Data Manager at Rho, you will collaborate extensively with interdisciplinary project teams throughout the study lifecycle to ensure data management activities are executed consistently, timely, and with high precision. Your role is critical in contributing to project success by developing and applying innovative automation tools, analyzing data trends, liaising effectively with biostatisticians, programmers, and clinical operations, and independently overseeing database creation and comprehensive data cleaning. You will also communicate data-related decisions clearly to sponsors while adhering strictly to regulatory standards and project procedures.
Key Responsibilities
- Design case report forms (CRFs) and key study documentation independently.
- Review clinical study protocols to identify potential issues and contribute to planning.
- Assist in data import preparation and development of standard reporting tools.
- Support electronic data capture (EDC) system design and testing, crafting edit checks and during user acceptance tests.
- Develop and refine templates and guidelines with minimal oversight.
- Lead data review strategies, manage query management and serious adverse event (SAE) reconciliation.
- Detect data patterns and prepare materials for review meetings.
- Support integration and testing of clinical data, including lab values and vendor data, ensuring discrepancies are flagged.
- Manage data lock processes, validation, and support trial master file (TMF) readiness.
- Enhance process quality, update documentation, and assist with audits applying risk-based quality management and quality by design principles.
- Coordinate tasks across multiple projects, track key performance indicators, and facilitate cross-functional team collaboration.
- Manage vendor interactions and support change management efforts.
- Mentor new team members and provide leadership within the project group.
- Attend in-person meetings as required, maintain professional communication, uphold confidentiality, and demonstrate Rho’s core values.
Required Qualifications
- Bachelor's degree with 2 to 5 years of clinical data management experience, including working extensively within clinical trial databases using commercial EDC platforms such as Medidata Rave, Medrio, RedCap, or Veeva.
- Knowledge of electronic data capture systems and principles of case report form design.
- Sound understanding of data review, cleaning, and reconciliation methodologies.
- Proven analytical and problem-solving abilities.
- Capability to autonomously utilize resources like SOPs and templates for project execution.
- Strong communication skills, both written and oral, with effective interpersonal abilities to collaborate within teams.
- Self-motivated with the capacity to manage multiple concurrent activities.
- Meticulous attention to detail and a commitment to delivering quality outcomes.
- Proficiency in Microsoft Office applications including Word, Excel, and PowerPoint.
Additional Information
Benefits at Rho include a comprehensive package for eligible employees featuring medical, vision, dental insurance, health savings account (HSA), flexible spending account (FSA), employee assistance program (EAP), life and disability insurance, and 401(k) retirement plans. Paid time off, holidays, parental leave, and bereavement leave are offered to all employees. The company promotes a balanced work-life approach encouraging flexibility.
Annual salary range: $70,000 to $110,000, depending on location, skills, and experience.
Rho is an Equal Opportunity Employer supporting veterans and individuals with disabilities.