Jobs · Information Technology · California

Associate Director, Data Management

Travere Therapeutics · San Diego Metropolitan Area · 1 mo ago
HybridInformation Technology$150k–$195k/yrFull-time
We need to output HTML fragment with sections: About the role? The posting includes a paragraph about company mission etc. That could be "About the role" or maybe "About the company". 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. 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 extract content: Department, Location, remote note, company description, job summary, responsibilities, education/experience requirements, additional skills/experience, total rewards offerings (benefits, compensation). Also note about travel, essential job function. We need to decide sections: maybe "About the role" (company description + job summary). "Responsibilities" (list). "Requirements" (education/experience). "Skills" (additional skills/experience). "Benefits" (total rewards offerings). "Pay" (target base pay range). Possibly "Schedule" not present (no schedule details). So omit Schedule. We must not include boilerplate like EEO, accommodation, etc. Remove those lines. We must preserve all substantive info: department, location, remote note, company mission paragraph, job summary, responsibilities list, education/experience requirements, additional skills/experience, total rewards offerings (benefits description, compensation description, target base pay range). Also note about travel (~10%), essential job function (face to face work, not 100% remote). Should we include that? It's substantive. Could be part of "About the role" or separate note. Probably include in a paragraph under About the role or maybe a separate "Additional Information". But we should avoid thin sections. Could incorporate into About the role paragraph. We must not repeat job title (Associate Director, Data Management) as heading. So we won't. We need to output only HTML fragment, no /, no markdown fences. Let's craft:

    About the role

    Department: 106300 Biometrics. Location: San Diego, USA – Remote (note: role requires occasional travel (~10%) and is not expected to be 100% remote; face‑to‑face work with colleagues and/or onsite in San Diego is required). At Travere Therapeutics we are a global team dedicated to making a difference in the lives of people living with rare disease. Our work is rewarding both professionally and personally as we identify, develop and deliver life‑changing therapies. We seek talented individuals who will thrive in our collaborative, diverse, fast‑paced environment and share our mission to identify, develop and deliver life‑changing therapies to people living with rare disease.

    Job Summary: The Associate Director, Data Management will oversee the start‑up and execution of several trials with a CRO or in‑house to ensure data quality and integrity. The individual will provide data management clinical development program leadership and perform a variety of complex tasks to ensure complete, accurate, high‑quality, and regulatory‑compliant data in support of publications and regulatory submissions.

    Then Responsibilities as ul. Then Requirements (Education/Experience) as ul? The instruction: Use
    • for any list of duties/requirements/benefits. So we can list responsibilities as ul, requirements as ul, skills as ul, benefits as ul. But we need to preserve all substantive info; we can combine education/experience requirements into a ul. Then Additional Skills/Experience as ul. Then Benefits: The total rewards offerings paragraph includes benefits description and compensation description. We could split into Benefits and Pay sections. Benefits: list of benefits: premium health, financial, work-life and well-being offerings, wellness and employee support programs, life insurance, disability, retirement plans with employer match, generous paid time off. Pay: mention competitive compensation package includes cash compensation (base pay and short-term incentive) and long-term incentive (company stock). Target Base Pay Range: $150,000.00 - $195,000.00. We should not include filler like "This information is current as of the date of this posting..." maybe we can keep but it's not filler; it's substantive but maybe we can include as a note. However it's not a list; we can put in a p. We must not include EEO etc. Let's construct. Check for duplication: The responsibilities list includes many items; we need to ensure we capture all. Responsibilities list from text: - Leadership and accountability for data management deliverables within a given development program. - Develop, maintain and execute data management timelines for a given development program. - Data Management Leadership in program related audits and regulatory inspections. - Lead and participate as data management subject matter expert at Study Management Team meetings. - Identify gaps in existing data management processes within a program and champion process change efficiencies. - Serve as Lead CDM to manage and provide daily oversight of CROs and third-party vendors in relation to DM to ensure successful clinical trial implementation and execution to completion. - Perform ongoing data review of clinical data to identify data discrepancies, general data trends, and corresponding resolutions as part of oversight over the CROs. - Review data for protocol deviation identification, as well as coding, and user acceptance testing of database. - Review documents produced by vendors and other departments. - Work cross-functionally with other departments within the company assessing and understanding their needs and attend clinical trial project team meetings as Lead CDM. - Strategize and plan for database locks and multiple deliverables across numerous programs. - Provide input on the development of standard operating procedures (SOPs) and study protocols from a data management perspective. - Provide guidance to clinical data management personnel on assigned projects. - Set-up, maintain and archive data management related project documentation (i.e., Data Management Plan, CRF Completion Guidelines, etc.). - Independently monitor own activities and project status for successful project deliverables according to timelines. - Adhere to budgets and timelines. - Ensure project is in reasonable state of inspection readiness and compliance. - Work with minimal supervision. - Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology. - Strong technical skills and experience with managing system integrations across data platforms. - Additional duties assigned as needed. That's a lot; we can keep as ul. Education/Experience Requirements: - Bachelor’s degree in life science, pharmacy or related field required. - Equivalent combination of education and applicable job experience may be considered. - 8+ years of direct Data Management experience required. Additional Skills/Experience: - Prior clinical trial vendor management and integration experience required. - Experience in managing outsourced studies and working for a CRO are preferred. - Excellent communication skills and interpersonal skills. - Experience in solving complex and increasingly difficult problems, taking appropriate corrective action, and identify and implement improvements. - Demonstrate knowledge of Clinical Data Management processes and capable of providing guidance to peers. - Demonstrate initiative, sound judgement, and flexibility; possess effective time management and organizational skills; and capable of working on multiple projects simultaneously under tight timelines or heavy stress. - Demonstrates project management skills (i.e. plan, organize, and manage activities to deliver specific study goals and objectives to measurable targets). - Demonstrates ability to interact professionally with personnel at all levels within and external to the company and be dependable and a team player. - Clear understanding of drug development process. - Understanding of ICH Guidelines and GCP Requirements. - Experience/Understanding of dictionary coding (i.e. MedDRA and WHODrug) and vendor reconciliation. - Ability to develop and maintain timelines. - Well-versed in different EDC Systems; preferred proficiency in Medidata RAVE. - Experience in leading data integrations using EDC, IRT, ePRO and external laboratory processing. - Self-motivated and can independently manage responsibilities. - Preferred experience in the use of Artificial Intelligence (AI) models to create efficient data collection methodologies or enhance data quality. - Accountability – Even in ambiguous circumstances, always demonstrate ownership for decisions and actions. - Ability to travel as necessary (approximately 10%). - All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote. We could incorporate travel and essential job function into About the role paragraph. Benefits: - Premium health, financial, work-life and well-being offerings for eligible employees and dependents. - Wellness and employee support programs. - Life insurance. - Disability. - Retirement plans with employer match. - Generous paid time off. Pay: - Competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock). - Target Base Pay Range: $150,000.00 - $195,000.00. We could also note that actual pay depends on factors. We should not include the line "This information is current as of the date of this posting and may be modified in the future." Might be considered filler? It's substantive but maybe we can keep as a p note. However it's not a list; we could include as a p under Pay section. But the instruction: Prefer a few substantive sections over many thin ones. So maybe combine Benefits and Pay into one "Total Rewards" section? But they gave examples of Benefits, Pay sections. We can keep both if they have real content. We must not include boilerplate like EEO etc. Now produce HTML. Let's craft:

      About the role

      Department: 106300 Biometrics. Location: San Diego, USA – Remote (role requires occasional travel (~10%) and is not expected to be 100% remote; face‑to‑face work with colleagues and/or onsite in San Diego is required). At Travere Therapeutics we are a global team dedicated to making a difference in the lives of people living with rare disease. Our work is rewarding both professionally and personally as we identify, develop and deliver life‑changing therapies. We seek talented individuals who will thrive in our collaborative, diverse, fast‑paced environment and share our mission to identify, develop and deliver life‑changing therapies to people living with rare disease.

      Job Summary: The Associate Director, Data Management will oversee the start‑up and execution of several trials with a CRO or in‑house to ensure data quality and integrity. The individual will provide data management clinical development program leadership and perform a variety of complex tasks to ensure complete, accurate, high‑quality, and regulatory‑compliant data in support of publications and regulatory submissions.

      Responsibilities

      • Leadership and accountability for data management deliverables within a given development program.
      • Develop, maintain and execute data management timelines for a given development program.
      • Data Management Leadership in program related audits and regulatory inspections.
      • Lead and participate as data management subject matter expert at Study Management Team meetings.
      • Identify gaps in existing data management processes within a program and champion process change efficiencies.
      • Serve as Lead CDM to manage and provide daily oversight of CROs and third‑party vendors in relation to DM to ensure successful clinical trial implementation and execution to completion.
      • Perform ongoing data review of clinical data to identify data discrepancies

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