Clinical Data Manager II

Roswell Park Comprehensive Cancer Center

11d•$35 - $44

About The Position

The Clinical Data Manager II is responsible for the collection, management, quality control, and overall integrity of clinical trial data for studies conducted by the Clinical Trial Development Division within the Department of Biostatistics and Bioinformatics. Working closely with investigators, biostatisticians, clinical research staff, sponsors, vendors, and other stakeholders, the Clinical Data Manager II supports all phases of the data management process, from study startup through database lock and study closeout. Responsibilities include contributing to protocol and study plan development; designing and maintaining clinical trial databases and electronic Case Report Forms (eCRFs); developing user requirements, edit checks, data validation rules, and query logic; and ensuring adherence to data standards, Good Clinical Practice (GCP), protocol requirements, and applicable regulatory guidelines. The Clinical Data Manager II coordinates User Acceptance Testing (UAT) activities, reviews database validation documentation, and ensures that clinical data management systems are fit for purpose and ready for study implementation. The incumbent performs ongoing data review, discrepancy management, and quality control activities to ensure that study data are accurate, complete, consistent, and audit-ready. This role is responsible for reconciling data from external sources, including sponsors, central laboratories, imaging vendors, and other third-party providers, with the primary clinical database and for collaborating with internal and external partners to identify, investigate, and resolve data issues in a timely manner. Additional responsibilities include developing and maintaining study-specific data management documentation, monitoring data quality metrics and study timelines, supporting interim analyses and statistical reviews, and managing database freeze and lock activities. The Clinical Data Manager II serves as a subject matter expert for data management processes, provides guidance on data collection and quality standards, and contributes to process improvement initiatives that enhance data quality, efficiency, and operational excellence. This position plays a critical role in ensuring the availability of reliable, high-quality clinical trial data to support scientific publications, regulatory submissions, and informed clinical development decisions. The pay range for this position is $35.36 - $43.75/hour. The actual offer may vary based on qualifications, skills, and experience.

Requirements

Bachelor’s degree in a science or medical field and the equivalent of two (2) years of full-time clinical data management experience; or
Associate’s degree in a science or medical field and the equivalent of four (4) years of full-time clinical data management experience.
Current certification by the Association of Clinical Research Professional (ACRP); or
Current certification by the Society of Clinical Research Associates (SOCRA); or
Other comparable research-related certifications recognized by Roswell Park Comprehensive Cancer Center as appropriate for this title.
Incumbents must obtain certification through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) or from other comparable research-related certifications recognized by Roswell Park Comprehensive Cancer Center as appropriate for this title within one (1) year of appointment as a condition of continued employment.
Degrees must be conferred by an accredited school, college, or university, or by an institution recognized by Roswell Park Comprehensive Cancer Center and/or Health Research Incorporated as adhering to acceptable educational standards.
Strong critical thinking and analytical skills.
Sound judgment.
Ability to identify and effectively resolve complex problems.
Adaptability in a dynamic research environment.
Ability to work collaboratively as part of a multidisciplinary team.
Strong interpersonal skills.
Excellent written and verbal communication skills.
Ability to interact effectively and professionally with colleagues, study teams, investigators, sponsors, and supervisors.
Ability to manage competing priorities.
Attention to detail.
Ability to contribute to a culture of teamwork and continuous improvement.

Nice To Haves

Minimum of five (5) years of experience performing clinical data management activities in support of clinical trials including experience supporting database lock activities, data cleaning, query management, and reconciliation of external datasets.
Experience designing and developing Case Report Forms (CRFs) using industry data standards, including CDASH, common data elements (CDEs), or other clinical data standards.
Hands-on experience with Medidata Rave Electronic Data Capture (EDC) systems, including database and CRF design in Rave Architect, user acceptance testing (UAT), data review, and query management.
Experience managing trials within the National Clinical Trials Network (NCTN) and familiarity with NIH-supported tools such as the Oncology Patient Enrollment System (OPEN), Regulatory Support System (RSS), Data Quality Portal (DQP), and Cancer Therapy Evaluation Program Adverse Event Reporting System (CTEP-AERS).
Proficiency in Microsoft Office applications, including Outlook, Word, Excel, PowerPoint, and Teams.
Demonstrated ability to manage multiple studies and priorities simultaneously while meeting project timelines and deliverables.
Excellent written and verbal communication skills, with the ability to collaborate effectively with investigators, sponsors, vendors, biostatisticians, and clinical research staff.
Experience supporting database lock activities, data cleaning, query management, and reconciliation of external datasets is preferred.

Responsibilities

Collection, management, quality control, and overall integrity of clinical trial data.
Support all phases of the data management process, from study startup through database lock and study closeout.
Contribute to protocol and study plan development.
Design and maintain clinical trial databases and electronic Case Report Forms (eCRFs).
Develop user requirements, edit checks, data validation rules, and query logic.
Ensure adherence to data standards, Good Clinical Practice (GCP), protocol requirements, and applicable regulatory guidelines.
Coordinate User Acceptance Testing (UAT) activities.
Review database validation documentation.
Ensure clinical data management systems are fit for purpose and ready for study implementation.
Perform ongoing data review, discrepancy management, and quality control activities.
Reconcile data from external sources with the primary clinical database.
Collaborate with internal and external partners to identify, investigate, and resolve data issues.
Develop and maintain study-specific data management documentation.
Monitor data quality metrics and study timelines.
Support interim analyses and statistical reviews.
Manage database freeze and lock activities.
Serve as a subject matter expert for data management processes.
Provide guidance on data collection and quality standards.
Contribute to process improvement initiatives.