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.
Position Summary:
We are seeking a Principal Data Manager with a keen attention to detail who will be responsible for overseeing the start-up and execution of clinical trials when partnering 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.
Responsibilities:
Act as the 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.
Manage system integrations across data platforms.
Ensure CRO and third-party data review outputs are reviewed according to agreed plans and filed in the Trial Master Plan as appropriate.
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, dictionary coding, and perform user acceptance testing of database.
Review documents produced by vendors and other departments.
Create data management process documents such as data management plans, data review specifications, data transfer agreements, diagram workflows, timelines and communication plans.
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 studies within a program ensuring consistency in process.
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.
Education/Experience Requirements:
Bachelor's degree in life science, pharmacy or related field. Equivalent combination of education and applicable job experience may be considered.
6 years of direct Data Management experience required.
Prior clinical trial vendor management and integration experience a must.
Additional Skills/Experience:
Demonstrated knowledge of drug development and Clinical Data Management processes and capable of providing guidance to peers.
Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology.
Understanding of ICH Guidelines and GCP Requirements.
Excellent communication skills and interpersonal skills.
Well-versed in different EDC Systems; preferred proficiency in Medidata RAVE.
Experience in managing outsourced studies and/or leading CRO data management teams.
Experience in leading data integrations using EDC, IRT, ePRO and external laboratory processing and vendor reconciliation.
Experience in solving complex and increasingly difficult problems, taking appropriate corrective action, and identify and implement improvements.
Ability to leverage Artificial Intelligence Models to support evolving data efficiencies is preferred.
Ability to develop and maintain timelines.
Understanding of dictionary coding (i.e. MedDRA and WHODrug).
Self-motivated and can independently manage responsibilities with minimal supervision.
Demonstrates project management skills (i.e. plan, organize, and manage activities to deliver specific study goals and objectives to measurable targets).
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 ability to interact professionally with personnel at all levels within and external to the company, be dependable and provide support as a team player.
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... For full info follow application link.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer
