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About the Role
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. This role supports all phases of the data management process, from study startup through database lock and study closeout, ensuring adherence to data standards, GCP, and regulatory guidelines. 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.
Responsibilities
- 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.
- Coordinate User Acceptance Testing (UAT) activities.
- Review database validation documentation.
- Perform ongoing data review, discrepancy management, and quality control activities.
- Reconcile data from external sources with the primary clinical database.
- Collaborate 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.
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.
- 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.
- 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.
- Ability to manage competing priorities.
- Maintain attention to detail.
- Contribute to a culture of teamwork and continuous improvement.
Skills
- Clinical Data Management
- Database Management
- Electronic Case Report Forms (eCRFs)
- User Requirements Development
- Edit Checks
- Data Validation Rules
- Query Logic
- Data Standards
- Good Clinical Practice (GCP)
- Regulatory Guidelines
- User Acceptance Testing (UAT)
- Database Validation
- Data Review
- Discrepancy Management
- Quality Control
- Data Reconciliation
- Medidata Rave EDC
- Rave Architect
- National Clinical Trials Network (NCTN)
- Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Teams)
- Critical Thinking
- Analytical Skills
- Problem Solving
- Collaboration
- Communication (Written and Verbal)
- Interpersonal Skills
- Time Management
- Attention to Detail
Location
- Roswell Park Division
Work Type
- Part time
- Grant Funded
Experience Level
- 2 years of full-time clinical data management experience (with Bachelor's degree)
- 4 years of full-time clinical data management experience (with Associate's degree)
- Minimum of 5 years of experience performing clinical data management activities
Education Level
- Bachelor’s degree in a science or medical field
- Associate’s degree in a science or medical field
- Certification by ACRP or SOCRA or comparable research-related certifications
Salary/Compensations
- $35.36 - $43.75/hour
Benefits
- Reasonable accommodation for individuals with disabilities
About the Company
- Health Research, Inc. (HRI) Roswell Park Division is committed to providing an environment where patients, families, employees and community are treated with courtesy and respect.
- They support an inclusive environment that nurtures the talents, skills and abilities of each individual to embody and reflect their core values: Innovation, Integrity, Teamwork, Commitment, Compassion and Respect.
- HRI participates in the E-Verify program.
Equal Opportunity
- 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 they do not discriminate against 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.