Clinical Data Manager II

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 (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.          

                                                                                                       

Additional qualifications                                                                                              

Additional key competencies include strong critical thinking and analytical skills, sound judgment, and the ability to identify and effectively resolve complex problems. The successful candidate will demonstrate adaptability in a dynamic research environment, the ability to work collaboratively as part of a multidisciplinary team, and strong interpersonal skills. Excellent written and verbal communication skills are essential, with the ability to interact effectively and professionally with colleagues, study teams, investigators, sponsors, and supervisors. The ability to manage competing priorities, maintain attention to detail, and contribute to a culture of teamwork and continuous improvement is highly desirable.

Equal Employment Opportunity Statement

Roswell Park Cancer Institute Corporation (RPCIC) and Health Research Inc. (HRI) Roswell Park Division believe that all persons are entitled to equal employment opportunities, and we do not discriminate against our employees, applicants or job seekers because of their race, color, religion, sex, sexual orientation, gender identity or expression, national origin, creed, age, disability, pregnancy-related condition, military or veteran status, marital or familial status, domestic violence victim status, citizenship status, genetic information, individual’s relationship or association with a member of a protected category or any other protected group status as defined by law.

Affirmative Action/Equal Opportunity Employer/Qualified Individuals with Disabilities/Qualified Protected Veterans

Reasonable Accommodation Request

RPCIC and HRI are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email [email protected]  and let us know the nature of your request and your contact information.

Our Core Values

RPCIC and HRI are committed to providing an environment where patients, families, employees and community are treated with courtesy and respect. We support an inclusive environment that nurtures the talents, skills and abilities of each individual to embody and reflect our core values: Innovation, Integrity, Teamwork, Commitment, Compassion and Respect.

Grant Funding

This is a grant-funded position.  Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables is required.

E-Verify Employer

Health Research Inc. (HRI) Roswell Park Division participates in the E-Verify program.