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Principal Clinical Data Manager

Company: Travere Therapeutics
Location: San Diego
Posted on: February 23, 2021

Job Description:

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients.--Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients. Position Summary: We are seeking a Principal Clinical Data Manager with a keen attention to detail who will be responsible for overseeing the start-up and execution of several trials with a CRO or in-house to ensure data quality and integrity. The individual will perform a variety of complex tasks to ensure complete, accurate, high quality, and regulatory compliant data in support of publications and regulatory submissions. Essential Functions:

  • Single point of accountability for data management deliverables at an assigned level within a given clinical development program.
  • 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. Qualifications:
    • Bachelor's degree in life science, pharmacy or related field. Equivalent combination of education and applicable job experience may be considered.
    • Minimum 6 years of direct Data Management experience required.
    • Prior clinical trial vendor management and integration experience a must.
    • Experience in managing outsourced studies and working for a CRO are preferred.
    • 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.
    • 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.
    • 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.
    • 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.
    • Demonstrates ability to interact professionally with personnel at all levels within and external to the company and be dependable and a team player.
    • Demonstrates project management skills (i.e. plan, organize, and manage activities to deliver specific study goals and objectives to measurable targets).
    • Accountability - Even in ambiguous circumstances, always demonstrate ownership for decisions and actions.
    • Ability to travel as necessary (approximately 10%). Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer Posted 30+ Days Ago Full time R-100017 About Us Travere Therapeutics is a biopharmaceutical company with a global team dedicated to working with the rare disease community to identify, develop and deliver life-changing therapies. The Company's development efforts are led by sparsentan, a product candidate in late-stage development for focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN) - rare kidney disorders that often lead to end-stage kidney disease. The company is also advancing TVT-058 for the treatment of classical homocystinuria, a genetic metabolic disorder that can cause life-threatening thrombotic events. Travere Therapeutics' early research efforts include partnering with leaders in patient advocacy and government research to identify potential therapeutics for NGLY1 deficiency and Alagille syndrome, conditions with no approved treatment options. The Company also delivers four FDA-approved therapies, Chenodal--, Cholbam--, Thiola-- and Thiola EC--, and is committed to ensuring broad access, educational and financial support for patients. For more information, visit travere.com.

Keywords: Travere Therapeutics, San Diego , Principal Clinical Data Manager, Executive , San Diego, California

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