Jobs · Analyst · New York

Senior Clinical Data Manager

BioSpace · Dunkirk, NY · 4 wk ago
Analyst$118k/yrFull-time
We need to output HTML fragment with sections: About the role? Actually we need to use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to include only sections that have real specific content. We need to parse the posting. Company Overview: description of company. Could be "About the role"? Actually "About the role" is typical heading for role summary. We have "Position Summary" and "Essential Functions". Could map to "About the role" (summary) and "Responsibilities" (essential functions). Then "Education & Experience" -> Requirements/Qualifications. "Knowledge, Skills, & Abilities" -> Skills. "Working Environment / Physical Environment" maybe schedule? It mentions regular work schedule Monday-Friday, standard business hours, flexibility. So we can have Schedule section. Also "This position is eligible for a discretionary bonus and equity award. The annual base pay range ..." So Pay section. Benefits: list of benefits. So we need Benefits section. We must not repeat job title as heading. No Job ID etc. We must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. The posting includes some EEO statement at end, also AI tools statement, etc. Those should be removed. We need to preserve all substantive information. Let's extract content. Company Overview: Could be placed under "About the role"? Actually "About the role" is about the role, not company. But we could include a short paragraph about company as part of About the role? The instruction: use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings? It says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Likely we should only use those headings if they have content. Could also include "Company Overview" as a heading? Not in list, but maybe we can incorporate into About the role? The instruction: "use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It suggests those are examples; we could also use other headings if needed? But they say "Prefer a few substantive sections over many thin ones." Probably we should stick to those headings. Thus we need to map content to those headings. Let's decide: - About the role: Could combine Position Summary and maybe company overview? The Position Summary: "The Senior Clinical Data Manager is an expert in clinical data management with demonstrated capability in building and maintaining clinical trial databases. They contribute to process improvements and initiatives within the Biometrics department as well as mentor and train junior staff members as applicable." We could also include a brief about company? Might be okay to include company overview in About the role? But the heading is About the role, not company. However we could still include company overview as a paragraph before About the role? The instruction says do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

or drop it. It doesn't forbid other headings besides those examples, but they gave examples. Safer to stick to those headings. Thus we can have:

About the role

ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. ... (company overview) ... The Senior Clinical Data Manager is an expert in clinical data management with demonstrated capability in building and maintaining clinical trial databases. They contribute to process improvements and initiatives within the Biometrics department as well as mentor and train junior staff members as applicable.

That includes company overview and position summary. Then Responsibilities: essential functions list. We need to convert essential functions bullet points into
  • . The essential functions are a long paragraph with many sentences separated by periods. We need to split into list items. Each sentence seems a duty. We'll create list items for each distinct duty. Let's extract sentences: 1. Create and/or review study-specific electronic or paper Case Report Forms (CRFs) using prior knowledge, protocol specific information and departmental standards. 2. Work efficiently to incorporate core clinical team input and produce CRFs in a timely manner. 3. Configure, migrate, and test electronic data capture (EDC) databases based on internal procedures, study requirements and system best practices. 4. Serve as database manager for the study specific clinical team, including compilation of edit checks. 5. Develop database requirements for use by EDC vendors. 6. Serve as study database manager and work with vendors to obtain deliverables in a timely manner. 7. Create and/or review study-specific data management and database documentation, which may include: - Data Management Plan - CRF Completion Guidelines - Coding Guidelines - Annotated CRFs - Edit Check Specifications 8. Attend study-specific team meetings and produce status reports and requested metrics, which may include query information or data trends. 9. Perform data review and query generation/closure. 10. Perform coding of verbatim terms such as adverse events and concomitant medications. 11. Collaborate with medical scientists for coding, consistency, review and approval. 12. Incorporating coding file into clinical database. 13. Participate in the development of new processes or revision of existing processes. 14. Train internal colleagues in clinical data management in either informal or formal settings as needed. 15. Train Investigators and/or Study Coordinators at Investigator Meeting on the CRFs, the EDC system, and the CRF completion guidelines as needed. 16. Provide data management expertise and support to the clinical teams using data management best practices. 17. Provide analytical insight into data management strategies and advise internal team with tactical strategies accordingly. 18. As necessary, provide work direction, guidance, mentoring, influence and support to junior staff. 19. Train junior staff in more complex clinical data management processes. 20. Perform other special projects and duties as requested. We need to ensure we don't lose any. Now Requirements/Qualifications: Education & Experience section. Text: "Bachelor’s Degree in a science-related field with 5+ years of experience required; orHigh school diploma with 9+ years of relevant experience required5+ years of clinical data management experience required.Experience working with EDC clinical databases requiredVeeva Vault CDMS and TrialMaster experience preferredMedDRA and WHO Drug coding experience preferred" We need to format nicely. Could be a list. We'll create
    • for each requirement. - Bachelor’s Degree in a science-related field with 5+ years of experience required; or - High school diploma with 9+ years of relevant experience required - 5+ years of clinical data management experience required - Experience working with EDC clinical databases required - Veeva Vault CDMS and TrialMaster experience preferred - MedDRA and WHO Drug coding experience preferred Note there is a missing space after "orHigh". We'll just keep as is. Skills: Knowledge, Skills, & Abilities section. Text: "Working knowledge of clinical research, good clinical practices, and regulatory requirements/guidelines.Knowledge of CDISC/STDM standards.Excellent verbal and written communication skills; good organizational and interpersonal Skills" We can list: - Working knowledge of clinical research, good clinical practices, and regulatory requirements/guidelines - Knowledge of CDISC/STDM standards - Excellent verbal and written communication skills; good organizational and interpersonal Skills Now Benefits: list from "Our competitive total rewards benefits package, for eligible employees, include:" then bullet list. We need to extract list: - Medical, Dental and Vision Plan Options - Health and Financial Wellness Programs - Employer Assistance Program (EAP) - Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability - Healthcare and Dependent Care Flexible Spending Accounts - 401(k) Retirement Plan with Company Match - 529 Education Savings Program - Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks - Paid Time Off (PTO) includes: 11 Holidays - Exempt Employees are eligible for Unlimited PTO - Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day We need to preserve all. We could flatten: maybe separate items. We'll create
      • for each bullet. Now Pay: The paragraph about base pay range. Text: "This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location. $117,900 (entry-level qualifications) to $131,000 (highly experienced) annually" We'll put that in

        . Schedule: from Working Environment / Physical Environment: "This position works onsite in Dunkirk, NYRegular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.Must possess mobility to work in a standard office setting and to use standard office equipment, including a computerLift and carry materials weighing up to 20 pounds" We need to separate sentences. We'll create

        maybe with schedule details. We could have a Schedule section with

        containing: "This position works onsite in Dunkirk, NY. Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval. Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer. Lift and carry materials weighing up to 20 pounds." Now we must remove boilerplate: The AI tools statement, EEO statement, etc. Also remove "The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed." That's application instructions? It's about timing; maybe we should remove as it's application instruction? The instruction says remove application instructions. So remove that line. Also remove "ImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions...." etc. Also remove EEO statement at end. Also remove duplicated lines? Not seeing duplicates. Now produce HTML fragment with only sections that have content. We'll order: About the role, Responsibilities, Requirements, Qualifications? Actually we have Requirements and Qualifications maybe combined? The instruction lists both Requirements and Qualifications as separate headings. We have Education & Experience which could be Requirements. Could also have Qualifications separate? Not present. We could put Education & Experience under Requirements. Qualifications maybe not present; we could omit. Skills we have. Benefits, Pay, Schedule. We should not create empty sections. Thus final HTML:

        About the role

        ...

        Responsibilities

        • ...
        • ...

        Requirements

        • ...
        • ...

        Skills

        • ...
        • ...

        Benefits

        • ...
        • ...

        Pay

        ...

        Schedule

        ...

        Check that we didn't include any filler like "commensurate with experience". Not present. Now craft the content precisely. Let's write About the role paragraph: "ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Design

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