Department:
106300 Biometrics
Location:
San Diego, USA- Remote
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.
Job Summary
The Associate Director, Data Management 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 provide data management clinical development program leadership and will 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, 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.
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.
Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
Benefits: Our benefits include 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 and generous paid time off.
Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Target Base Pay Range:
$150,000.00 - $195,000.00
*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate’s experience, education, skills, and location.
Travere will accept applications on an ongoing basis until a candidate is selected for the position.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.
If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.
