Jobs · Management · Massachusetts

Manager, Clinical Supply Systems

BioSpace · Cambridge, MA · 4 wk ago
Management$122k–$195k/yrFull-time
We need to output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. No Job ID etc. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. We need to parse the posting. Content: "The Role Moderna is seeking a Manager, Clinical Supplies Systems to oversee and manage IRT systems for Moderna’s growing portfolio of studies. This person will be required to work with external IRT vendors (day-to-day operations) to ensure Moderna’s clinical portfolio aligns with internal stakeholders and timelines from business. This position will work collaboratively and cross-functionally to gather relevant requirements and utilize the available resources to create the IRT system design, provide subject matter expertise, and ensure expert and on-time IRT system delivery and implementation. The successful candidate is a subject matter expert at IRT-related integrations, imaginative, skilled at understanding the needs of a clinical development operations organization with high attention to detail, a collaborative outlook, a positive leader, above no task, and the ability to pursue multiple options in parallel to meet project timelines 100% of the time. Forecasting applications and IRT product management background are a plus. Managers are expected to independently manage studies or oversee a small portfolio of programs and associated studies, contributing their expertise in IRT system management. They are anticipated to operate autonomously, with the Senior Manager/Associate Director serving as the primary contact for risk mitigation and issue escalation." Then "Here’s What You’ll Do" list. Then "Here’s What You’ll Bring To The Table" list. Then "Pay & Benefits" includes description and salary range. Then "About Moderna" description. Then "Equal Opportunities" etc (boilerplate to remove). Then "Accommodations" (boilerplate? Might be considered legal but maybe keep? It's about accommodations for disabilities; could be considered EEO/legal boilerplate; likely remove.) Then "Export Control Notice" (legal, remove). Thus we need sections: About the role (maybe from first paragraph?), Responsibilities (Here’s What You’ll Do), Requirements (maybe from Here’s What You’ll Bring To The Table?), Qualifications (maybe overlapping), Skills (maybe from requirements), Benefits, Pay, Schedule. But we must only include sections with real specific content. Let's extract. About the role: The first paragraph describing role. Could be used. Responsibilities: bullet list from Here’s What You’ll Do. Requirements: maybe from Here’s What You’ll Bring To The Table (experience, education, etc). Could be split into Requirements and Qualifications and Skills. But we need to avoid thin sections. Perhaps combine into Requirements (experience, education) and Skills (technical/soft skills). However we need to decide. Let's extract specifics. Here’s What You’ll Do (list): - Under the guidance of a Senior Manager or Associate Director, manage IRT Systems for assigned program(s) and studies at Moderna with autonomy - Responsible for IRT implementation project management, IRT requirements and design, user acceptance testing, and maintenance - May contribute to mentoring Clinical Supply Systems Specialists - Responsible for facilitation of IRT support, data changes, and working with Clinical Operations and Monitoring to achieve their goals - Responsible for UAT test case creation, oversee and facilitate signatures on documentation, and risk and impact assessment creation, etc. - Adheres to processes and ensure compliance to relevant SOPs - Responsible for administration and uploading documentation to appropriate eTMF - Collaborates cross-functionally to schedule projects, end-user training, meetings, and discussions - Deliver exceptional customer service and technical support to Clinical Operations, Biostatistics, Clinical Supplies, and Data Management under the directive of the Senior Manager - Serve as IRT Subject Matter Expert to other Moderna departments - Task assignments may expand in scope based on the individual's level of experience Here’s What You’ll Bring To The Table: - At least three to six years of clinical supply systems experience - Bachelor’s degree in a science-based subject (advanced degree preferred) - Prior Product Ownership Experience (strongly preferred) - Prior demonstration of innovation as it relates to integrations between clinical systems (IRT, EDC, etc.) in a clinical research environment - Understanding of Cold Chain distribution and the effect on IRT - IRT Subject Matter Expertise - Creative, capable problem-solver - Experience in establishing and maintaining relationships with vendors - Working knowledge of ICH, GAMP, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements - Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) - Successful candidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas. - Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes Pay & Benefits: - Paragraph about benefits: Competitive healthcare, plus voluntary benefit programs to support your unique needs; holistic approach to well-being, with access to fitness, mindfulness, and mental health support; Family planning benefits, including fertility, adoption, and surrogacy support; Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown; Savings and investments to help you plan for the future; Location-specific perks and extras - Salary range: $121,600.00 - $194,500.00. Also mention annual discretionary bonus, other incentive compensation, or equity award. Schedule: Not mentioned explicitly. No schedule info. So we should NOT create Schedule section. Benefits: we have content. Pay: we have salary range and bonus info. Thus sections: About the role, Responsibilities, Requirements (maybe combine experience/education), Qualifications (maybe skills?), Skills, Benefits, Pay. But we need to avoid duplication and thin sections. Let's think: Requirements could be the experience and education. Qualifications could be the specific expertise (IRT SME, innovation, etc). Skills could be technical proficiencies (MS Office, regulations knowledge, etc). However many items overlap. Better to have: About the role, Responsibilities, Requirements (experience + education), Qualifications (core competencies like IRT SME, innovation, vendor relationships, regulatory knowledge, problem solving, collaboration), Skills (MS Office proficiency), Benefits, Pay. But we need to ensure each section has substantive content, not just filler. Let's extract each. About the role: Use the first paragraph(s) up to before "Here’s What You’ll Do". Could combine two paragraphs: The Role paragraph and the following about managers expected to independently manage studies... Actually that is also part of role description. Let's include that. Responsibilities: list as
  • . Requirements: "At least three to six years of clinical supply systems experience" and "Bachelor’s degree in a science-based subject (advanced degree preferred)". Also maybe "Prior Product Ownership Experience (strongly preferred)" could be requirement but it's more qualification. We'll treat as requirement. Qualifications: list of: Prior demonstration of innovation as it relates to integrations between clinical systems (IRT, EDC, etc.) in a clinical research environment; Understanding of Cold Chain distribution and the effect on IRT; IRT Subject Matter Expertise; Creative, capable problem-solver; Experience in establishing and maintaining relationships with vendors; Working knowledge of ICH, GAMP, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements; Successful candidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas.; Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes. Skills: Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint). Benefits: list of benefits as described. Pay: salary range and bonus info. We must not include Schedule. Now ensure we don't include boilerplate like Equal Opportunities, Accommodations, Export Control Notice. Now produce HTML fragment. We need headings

    for each section. We must not repeat job title as heading. We must not include Job ID etc. We must not include markdown fences. We must output only HTML. Let's craft. Structure:

    About the role

    ...

    Responsibilities

    • ...
    • ...

    Requirements

    • ...
    • ...

    Qualifications

    • ...
    • ...

    Skills

    • ...
    • ...

    Benefits

    • ...
    • ...

    Pay

    ...

    Check that we don't have empty sections. Now write content. About the role paragraph: Combine: "The Role Moderna is seeking a Manager, Clinical Supplies Systems to oversee and manage IRT systems for Moderna’s growing portfolio of studies. This person will be required to work with external IRT vendors (day-to-day operations) to ensure Moderna’s clinical portfolio aligns with internal stakeholders and timelines from business. This position will work collaboratively and cross-functionally to gather relevant requirements and utilize the available resources to create the IRT system design, provide subject matter expertise, and ensure expert and on-time IRT system delivery and implementation. The successful candidate is a subject matter expert at IRT-related integrations, imaginative, skilled at understanding the needs of a clinical development operations organization with high attention to detail, a collaborative outlook, a positive leader, above no task, and the ability to pursue multiple options in parallel to meet project timelines 100% of the time. Forecasting applications and IRT product management background are a plus. Managers are expected to independently manage studies or oversee a small portfolio of programs and associated studies, contributing their expertise in IRT system management. They are anticipated to operate autonomously, with the Senior Manager/Associate Director serving as the primary contact for risk mitigation and issue escalation." That's a bit long but okay. Responsibilities list items as extracted. Requirements list: - At least three to six years of clinical supply systems experience - Bachelor’s degree in a science-based subject (advanced degree preferred) - Prior Product Ownership Experience (strongly preferred) Qualifications list: - Prior demonstration of innovation as it relates to integrations between clinical systems (IRT, EDC, etc.) in a clinical research environment - Understanding of Cold Chain distribution and the effect on IRT - IRT Subject Matter Expertise - Creative, capable problem-solver - Experience in establishing and maintaining relationships with vendors - Working knowledge of ICH, GAMP, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements - Successful candidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas. - Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes Skills list: - Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) Benefits list: - Competitive healthcare, plus voluntary benefit programs to support your unique needs - Holistic approach to well-being, with access to fitness, mindfulness, and mental health support - Family planning benefits, including fertility, adoption, and surrogacy support - Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown - Savings and investments to help you plan for the future - Location-specific perks and extras Pay paragraph: - The salary range for this role is $121,600.00 - $194,500.00. This is the lowest to

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