Jobs · Analyst · New Jersey

Clinical Trials Manager

Gilead Sciences · Parsippany, NJ · 1 mo ago
On-siteAnalyst$133k–$172k/yrFull-time
We need to output only HTML fragment with sections for headings: About the role? Actually the posting includes "Job Summary", "Job Description/ Key Responsibilities", "Basic Qualifications", "People Leader Accountabilities", "The Salary Range For This Position Is", "Benefits". Also location info maybe part of About the role? The instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use
  • for any list of duties/requirements/benefits, and

    for prose. 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. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. We need to decide which sections to include. The posting includes: - Location: "This role will be based out of our Parsippany, NJ location OR Foster City, California." Could be part of About the role or maybe a short paragraph. - Job Summary: description of role. - Job Description/Key Responsibilities: list of responsibilities. - Basic Qualifications: education/experience requirements. - People Leader Accountabilities: description of leadership expectations. - Salary Range: specific numbers for US Locations and Bay Area. - Benefits: mention of medical, dental, vision, life insurance, plus link. We should not include boilerplate like EEO, accommodation, etc. We need to use headings: maybe "About the role" (location + summary?), "Responsibilities", "Qualifications", "People Leader Accountabilities", "Pay", "Benefits". Could also have "Requirements" but we have Qualifications. We must not create Schedule section because not mentioned. We must not create Skills section unless present; not explicit. We need to preserve all substantive info. So we need to include location, job summary, responsibilities list, qualifications list, people leader accountabilities list, salary range specifics, benefits list. We need to format as HTML fragment: use

    for each section heading, then content: either

    for prose or

    • for lists. We need to ensure we don't repeat job title. We need to drop duplicated lines: there may be duplicated sentences like "Job Description" repeated; we need to consolidate. Let's extract content. First, location and job summary: "This role will be based out of our Parsippany, NJ location OR Foster City, California." "Job Summary We are seeking a Clinical Trials Manager (CTM) to support the Oncology pipeline. The CTM drives end-to-end operational delivery of Phase II and III oncology trials, ensuring high-quality execution through strong cross-functional leadership and CRO/vendor oversight. This role serves as a key contributor for study execution and study management by coordinating with the internal teams and external partners (including CROs and vendors), and ensuring alignment across all stakeholders to achieve study objectives. The CTM applies strong project management, clinical, and regulatory expertise to proactively identify risks, implement solutions, and maintains study timelines to meet the study deliverables for the in-house and/or hybrid model clinical trials." We can combine location and summary into About the role paragraph. Now responsibilities: The block after "Job Description/ Key Responsibilities" includes many sentences, many start with verbs. We need to turn into list items. List them: - Prior Oncology experience and prior CRO/Pharma/Biotech experience is required. (This is actually a qualification but appears in responsibilities section; but we can treat as requirement.) - Coordinating and supervising all aspects of clinical study. - Assists Clinical Program Manager in the overall study management. - Provide input into study protocols, investigator brochures, case report forms, and informed consents, final study reports, oversee/author study plans, and presentations. - Maintains study timelines, including documentation and communications. - Contributes to development of study budget. - Contributes to development of RFPs and participate in selection of CROs/vendors. - May manage CROs/vendors or functional service providers. - May serve as the key operational contact for Gilead studies, providing oversight for the site evaluation, initiation, and close-out visits in addition to conducting oversight monitoring visits. - Provide oversight of study sites/region and review routine regulatory documents to ensure that CROs /vendors are in compliance with protocols, regulatory requirements, SOPs, and monitoring plans. - Ensures effectiveness of site budget/contract process. - May be asked to train CROs, vendors, investigators, and study coordinators on study requirements. - Coordinates review of data listings and preparation of interim/final clinical study reports and appendices, including resolving any data discrepancies. - Assists in determining the activities to support a project’s priorities within functional area. - Develop tools and processes that optimize project efficiencies and effectiveness. - Travel is required. - Excellent teamwork, communication, decision-making and organizational skills are required. - Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable. - Must be able to generally understand, interpret, and explain protocol requirements to others. - Must be able to prioritize multiple tasks. - May serve as a resource for others within the company for clinical trials management expertise. - Under general supervision, is able to examine functional issues from an organizational perspective. - Must have general, functional expertise to support SOP development and implementation. We need to decide if some of these are qualifications rather than responsibilities. But the instruction: Use
      • for any list of duties/requirements/benefits. So we can combine duties and requirements into one list under Responsibilities or maybe separate sections: Responsibilities and Requirements. However we have a "Basic Qualifications" section later. So we should separate: Responsibilities (duties) and Requirements (qualifications). The "Basic Qualifications" includes education/experience: "5+ Years with BS/BA in a relevant scientific discipline. 3+ Years with MS/MA in a relevant scientific discipline." Also there are other qualification-like statements in responsibilities: Prior Oncology experience and prior CRO/Pharma/Biotech experience is required. Excellent teamwork, communication, decision-making and organizational skills are required. Thorough knowledge... desirable. Must be able to generally understand... Must be able to prioritize multiple tasks. May serve as a resource... Under general supervision... Must have general, functional expertise to support SOP development and implementation. These could go under Requirements or Qualifications. But we already have Basic Qualifications for education/experience. We could have a "Requirements" section for skills/knowledge etc. However the instruction says prefer a few substantive sections over many thin ones. So maybe combine qualifications and responsibilities into one "Responsibilities" list? But that would mix duties and requirements, losing clarity. However we could have sections: "Responsibilities" (duties), "Qualifications" (education/experience + skills/knowledge). The People Leader Accountabilities could be its own section. Pay section: Salary range specifics. Benefits section: mention of medical, dental, vision, life insurance, plus link. We need to avoid filler like "Other US Locations: $133,195.00 - $172,370.00. Bay Area: $146,540.00 - $189,640.00." That's specific, so we include. Now we need to strip boilerplate: The long EEO, accommodation, polygraph, etc. Remove. Also remove "For Additional Benefits Information, Visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing" maybe we keep as part of benefits? It's a link; we could keep as part of benefits prose. Also remove "Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans." That's generic but still substantive? It's basically repeating benefits eligibility; we could keep but it's somewhat boilerplate. Might be okay to keep but we can drop as it's generic. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The benefits eligibility sentence is not exactly boilerplate but could be considered generic; but it's part of benefits description. I'd keep it maybe. Also remove "For Jobs In The United States Gilead Sciences Inc. is committed to providing equal employment opportunities..." that's EEO boilerplate; remove. Also remove "Our environment respects individual differences..." etc. Remove. Also remove "For Current Gilead Employees And Contractors Please apply via the Internal Career Opportunities portal in Workday." That's application instruction; remove. Now we need to ensure we don't include any headings with empty content. Let's draft sections:

        About the role

        This role will be based out of our Parsippany, NJ location OR Foster City, California. We are seeking a Clinical Trials Manager (CTM) to support the Oncology pipeline. The CTM drives end-to-end operational delivery of Phase II and III oncology trials, ensuring high-quality execution through strong cross-functional leadership and CRO/vendor oversight. This role serves as a key contributor for study execution and study management by coordinating with the internal teams and external partners (including CROs and vendors), and ensuring alignment across all stakeholders to achieve study objectives. The CTM applies strong project management, clinical, and regulatory expertise to proactively identify risks, implement solutions, and maintains study timelines to meet the study deliverables for the in-house and/or hybrid model clinical trials.

        Responsibilities

        • Coordinating and supervising all aspects of clinical study.
        • Assists Clinical Program Manager in the overall study management.
        • Provide input into study protocols, investigator brochures, case report forms, and informed consents, final study reports, oversee/author study plans, and presentations.
        • Maintains study timelines, including documentation and communications.
        • Contributes to development of study budget.
        • Contributes to development of RFPs and participate in selection of CROs/vendors.
        • May manage CROs/vendors or functional service providers.
        • May serve as the key operational contact for Gilead studies, providing oversight for the site evaluation, initiation, and close-out visits in addition to conducting oversight monitoring visits.
        • Provide oversight of study sites/region and review routine regulatory documents to ensure that CROs/vendors are in compliance with protocols, regulatory requirements, SOPs, and monitoring plans.
        • Ensures effectiveness of site budget/contract process.
        • May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
        • Coordinates review of data listings and preparation of interim/final clinical study reports and appendices, including resolving any data discrepancies.
        • Assists in determining the activities to support a project’s priorities within functional area.
        • Develop tools and processes that optimize project efficiencies and effectiveness.
        • Travel is required.
        Note: we omitted some items that are more skill/knowledge like "Excellent teamwork..." etc. Those could go under Requirements.

        Qualifications

        • Prior Oncology experience and prior CRO/Pharma/Biotech experience is required.
        • 5+ Years with BS/BA in a relevant scientific discipline.
        • 3+ Years with MS/MA in a relevant scientific discipline

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