Clinical Data Manager

Beacon Hill; United States; Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

A leading recruitment firm in the United States is seeking an experienced clinical data management leader with over 8 years of expertise. The role involves overseeing end-to-end data management for clinical trials, ensuring compliance with regulatory standards, and collaborating closely with cross-functional teams. Candidates should possess a Bachelor's in life sciences and demonstrate strong leadership and problem-solving skills while managing competing priorities in a dynamic environment. This position promotes diversity and encourages individuals with disabilities and protected veterans to apply.

Qualifikationen

• 8+ years of experience in clinical data management.
• Extensive knowledge of clinical trials process and regulatory requirements.
• Strong working knowledge of CDISC standards and FDA regulations.

Aufgaben

• Lead clinical data management function, ensuring deliverables meet quality standards.
• Oversee end-to-end data management for late phase clinical trials.
• Identify risks, propose solutions, and report on data management metrics.

Kenntnisse

Leadership

Clinical data management

Regulatory compliance

Problem-solving

Team collaboration

Attention to detail

Ausbildung

Bachelor's in life sciences or related discipline

Jobbeschreibung

Responsibilities

• Provide leadership for clinical data management function; ensure data management deliverables are completed on time, within budget and in accordance with quality standards and study requirements
• Responsible for leading end-to-end data management activities for late phase clinical trial(s); responsible for the oversight of CRO and/or DM vendors to ensure that project goals are achieved and overseeing adherence to scope of work and service agreements
• Represent data management in Study Management Team (SMT) meetings; proactively identify and communicate risks, suggest solutions and provide updates
• Establish and maintain strong relationships with cross-functional teams, vendors and key stakeholders for successful execution of clinical trial
• Collaborate with study statistician and statistical programmer to support production of clinical trial reports and other study deliverables
• Develop and maintain study-specific DM documents (e.g., electronic Case Report Form (eCRF) completion guidelines, annotated CRFs, CRF and data validation specifications, data transfer agreements, data management plan and data review plan)
• Lead and oversee Electronic Data Capture (EDC) build, modifications and deployment including creation and execution of User Acceptance Testing (UAT) plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., Interactive Response Technology (IRT)); develop and maintain EDC build/modification timelines
• Maintain study DM related documents for inspection readiness
• Develop data transfer agreements with external vendors
• Review and provide feedback on clinical documents (e.g., clinical protocols, statistical analysis plans, protocol deviation plans, vendor specifications)
• Report data management metrics and trends; proactively identify barriers to timely and successful trial execution and propose solutions
• Lead clinical data review of data listings, external data reconciliation reports, SAE reconciliation and implement data review strategy
• Serve as a subject matter expert on data management systems and processes
• Contributes to the development and improvement of data management standard operating procedures (SOPs) and document templates

Qualifications

• Bachelors in life sciences or related discipline with 8 or more years of experience in clinical data management
• Requires extensive knowledge of clinical data management principles, clinical trials process and regulatory requirements
• Excellent ability to manage competing priorities in a changing environment
• Strong working knowledge of CDISC standards, FDA and ICH/GCP regulations and guidelines
• Proficient on EDC configuration and design, testing and validation, data collection and data review process, and data standardization
• Self-motivated and takes pride in your work
• Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships
• Attention to detail, ability to proactively identify issues and address with solutions-oriented approach

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.