Clinical Data Manager II

We need to output HTML fragment with sections only if content present. Use

for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We have summary (About the role). Responsibilities: many bullet points. Qualifications: required education and experience, certification requirement, etc. Preferred qualifications maybe under Skills? Actually we have Qualifications (required) and Preferred Qualifications. Also Additional Qualifications (competencies). Could combine into Qualifications and Skills sections. Pay: we have pay range. Schedule: we have part time weekly hours 10, FTE 0.25, shift first shift. So schedule info present. Benefits: not mentioned. So we should not include Benefits heading. Also we should not include empty sections. We need to preserve all substantive info, not invent. Remove boilerplate: EEO, accommodation, core values, grant funding, e-verify, etc. Also remove duplicated lines. Also remove application instructions (none). Also remove time type etc? Those are metadata; we can fold into short p or drop. The instruction: do NOT put Job ID/requisition numbers as headings — fold minor metadata into a short

or drop it. So we can include a short p for Job Type, Company, Department, Time Type, Weekly Hours, FTE, Shift maybe as a paragraph after the title? But title already shown; we can include a paragraph with those details. We must not repeat job title as heading. So start with maybe a

containing metadata: 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). Then sections. Now content: About the role: summary paragraph. Responsibilities: list bullet points from responsibilities paragraph. Need to extract each duty. Let's parse responsibilities paragraph: "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." We can break into bullet list items. Qualifications: Required Education and Experience, Certification Requirement, etc. We have: "Qualifications: Required Education and Experience Certification Requirement 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. Education and Experience 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. Note: 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." Then "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." Then "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." We can combine Qualifications (required) and maybe Skills (preferred + additional). But we have headings: Qualifications, Skills. We could put required under Qualifications, and preferred + additional under Skills. Or we could put all under Qualifications and omit Skills. But we need to decide based on content. Since we have both required and preferred, we could have Qualifications (required) and Skills (preferred + additional). That seems reasonable. Pay: we have pay range $35.36 - $43.75/hour. Also note actual offer may vary based on qualifications, skills, and experience. That's substantive, so include Pay section. Schedule: we have part time weekly hours 10, FTE 0.25, shift first shift. So include Schedule section. Benefits: none, omit. Now construct HTML. We need to output only HTML fragment, no /, no markdown fences. We'll start with a

for metadata. Then

About the role

summary

Then

Responsibilities

• ... each bullet. We need to split responsibilities into sensible bullet items. Let's list: - Collect, manage, quality control, and ensure overall integrity of clinical trial data for studies conducted by the Clinical Trial Development Division within the Department of Biostatistics and Bioinformatics. - Work closely with investigators, biostatisticians, clinical research staff, sponsors, vendors, and other stakeholders. - 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 that clinical data management systems are fit for purpose and ready for study implementation. - Perform ongoing data review, discrepancy management, and quality control activities to ensure study data are accurate, complete, consistent, and audit-ready. - Reconcile data from external sources (sponsors, central laboratories, imaging vendors, other third-party providers) with the primary clinical database. - Collaborate with internal and external partners to identify, investigate, and resolve data issues in a timely manner. - 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 that enhance data quality, efficiency, and operational excellence. - Ensure availability of reliable, high-quality clinical trial data to support scientific publications, regulatory submissions, and informed clinical development decisions. That seems comprehensive. Now Qualifications (required): We need to list certification requirement, education/experience, note about obtaining certification within 1 year, degree accreditation. We can bullet: - 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. - 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. - Must obtain certification through ACRP, SOCRA, or other comparable research-related certifications recognized by Roswell Park Comprehensive Cancer Center 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. Now Skills (preferred + additional): We can bullet: - 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 (preferred