Principal Clinical Data Manager
Company: Travere Therapeutics
Location: San Diego
Posted on: February 23, 2021
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
- 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
- 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
- Provide guidance to clinical data management personnel on
- Set-up, maintain and archive data management related project
documentation (i.e., Data Management Plan, CRF Completion
- 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
- 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
- Prior clinical trial vendor management and integration
experience a must.
- Experience in managing outsourced studies and working for a CRO
- 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
- Experience in leading data integrations using EDC, IRT, ePRO
and external laboratory processing
- Self-motivated and can independently manage
- Excellent communication skills and interpersonal skills.
- Experience in solving complex and increasingly difficult
problems, taking appropriate corrective action, and identify and
- 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
Keywords: Travere Therapeutics, San Diego , Principal Clinical Data Manager, Executive , San Diego, California
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