Clinical Data Manager II

roswellpark; United States; On-site; USD 49,000 - 60,000; Part time

Job summary

Health Research, Inc. (HRI) Roswell Park Division is seeking a Clinical Data Manager II to oversee the collection, management, and quality control of clinical trial data within the Biostatistics & Bioinformatics Department.

This role coordinates with investigators, sponsors, vendors, and study stakeholders to ensure data integrity from startup through database lock and study closeout. The position requires expertise in data standards, GCP, and regulatory guidelines, plus experience with eCRFs

Qualifications

• Must have 1) certifications (ACRP or SOCRA) or equivalent recognized by Roswell Park Comprehensive Cancer Center; 2) bachelor's or associate degree in science/medical field with corresponding experience; 3) familiarity with data standards and QC processes.

Responsibilities

• Oversee collection, management, quality control, and integrity of clinical trial data.
• Coordinate data management activities from study startup through database lock and closeout.
• Design and maintain databases and electronic Case Report Forms (eCRFs); develop edit checks and query logic.
• Coordinate UAT, validate data management documentation, and ensure regulatory compliance.

Job description

Title

Clinical Data Manager II

Job Type

Regular

Company

Health Research, Inc. (HRI) Roswell Park Division

Department

Biostatistics & Bioinformatics

Time Type

Part time

Weekly Hours

10

FTE

0.25

Shift

First Shift (United States of America)

Summary

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.

Qualifications

Required Education and Experience

Certification Requirement

• 1. Current certification by the Association of Clinical Research Professional (ACRP); or
• 2. Current certification by the Society of Clinical Research Associates (SOCRA); or
• 3. Other comparable research-related certifications recognized by Roswell Park Comprehensive Cancer Center as appropriate for this title.

Education and Experience

• 1. Bachelor's degree in a science or medical field and the equivalent of two (2) years of full-time clinical data management experience; or
• 2. Associate's degree in a science or medical field and the equivalent of four (4) years of full-time clinical data management experience.

NOTE:

• 1. 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.
• 2. 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.

Preferred qualifications for qualifications

• 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