Senior Clinical Research Data Manager

Job Summary

The Senior Clinical Research Data Manager will perform a variety of data management duties of a complex and technical nature in support of clinical research studies conducted by principal investigators (PIs) for the clinical research program to ensure adherence to protocols and quality of information received.

Responsibilities

• Maintains a close, collaborative working relationship with the PIs in your department to effectively manage research studies, with the department, administrative team, and department staff.
• Builds and maintains effective relationships with key study personnel, clinical resources and colleagues.
• Oversees the data management activities of a specific work unit as the data management expert.
• Responsible for all data management aspects of clinical studies and efficiently performs all data management activities within an assigned study or studies.
• Provides data management expertise to the team in identifying opportunities for improvement.
• Ensures validity of research results through timely, accurate, and complete data submission, query resolution, and reporting of deviations.
• May delegate tasks to team members within the study program.
• Demonstrates proficiency in the use of clinical and research-related computer programs.
• Ensures that relevant data from the source document are abstracted and recorded in the clinical trial case report forms and that every data point can be verified within the source document.
• Utilizes analytical thinking, attention to detail, and problem-solving skills.
• Facilitates communication between the site and study sponsor, CRO, and/or regulators, and exhibits teamwork skills necessary for managing the data collection and reporting process.
• Will train other data managers within the unit.
• Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
• Accountable for all data management tasks in support of moderate to high-complexity clinical research studies, which may include a mix of industry, investigator-initiated trials (IITs), and National Cancer Trial Network (NCTN) trials, under limited supervision and while maintaining a high degree of confidentiality.
• Primary study assignments are considered a higher risk in terms of impact on the reputation and integrity of cancer centers and are generally provided less oversight from external clinical trial monitoring.
• Coordinates document collection and review in collaboration with the principal investigator (PI).
• Performs other related work as needed.

Minimum Qualifications

Education: Minimum requirements include a college or university degree in related field. Work Experience: Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Preferred Qualifications

Education: Bachelor's degree. Experience: Progressively responsible relevant clinical research experience.

Technical Skills or Knowledge

• Proven excellence in data management.
• Perform data monitoring, query generation and query resolution.
• Perform research data management with minimal supervision.
• Knowledge of Microsoft Word, Excel and Adobe Acrobat.
• Knowledge of medical and/or clinical trial terminology.
• Train junior data managers.
• Experience troubleshooting clinical trials; uncovering issues and identifying the most appropriate intervention.
• Knowledge in relevant scientific field.

Preferred Competencies

• Strong analytical skills.
• Handle competing demands with diplomacy and enthusiasm.
• Strong data management skills.
• Work collaboratively and with divisional research offices.
• Maintain a high degree of confidentiality with clinical data and client's proprietary data.
• Adaptability to changing working situations and work assignments.
• Work independently and as part of a team.
• Strong attention to detail.
• Excellent multi-tasking skills.