Senior Clinical Data Manager
Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases. As the leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, Pliant is developing small molecule drug candidates specifically designed to impact the fibrotic process.
The Company’s lead product candidate, bexotegrast (PLN-74809), is an oral small molecule, selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting BEACON-IPF, a Phase 2b trial of bexotegrast for the treatment of IPF and INTEGRIS-PSC, a Phase 2a trial of bexotegrast for the treatment of PSC.
Pliant has also developed PLN-1474, a small molecule, selective inhibitor of αvß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis. Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology and muscular dystrophies.
Description
The Senior Clinical Data Manager (CDM) is responsible for data management activities across one or more studies from study start-up through study closure to ensure completion per established project team goals and objectives. The Senior CDM will report to the Head of Clinical Data Management and will work closely with a cross-functional team in a fast-paced high growth environment team to ensure that clinical data are complete, high quality and delivered on time and budget.
This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).
Responsibilities
- Independently leads EDC development, including CRF development, EDC specification process, edit check development and User Acceptance Testing including test scripts and execution logs, issue logs, and UAT summary reports.
- Reviews and assists in the development of study documents drafted by CROs such as data transfer agreements, eCRF Completion Guidelines, and Data Management Plans.
- Ensures the quality of clinical data within the EDC and other databases through data review and data reconciliation processes and communicates any outstanding issues.
- Develops, in collaboration with the CRO, a clean patient tracker.
- Coordinates transfers of SAS datasets or electronic data transfers from CROs.
- Leads database lock process.
- Monitors and tracks the quality of all data management deliverables ensuring audit practices have been enacted to validate the quality and assurance of database content and supporting documents.
- Responsible for compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practice.
- Effectively oversees contracted vendors, or vendor groups within CRO, to ensure data are complete, accurate and delivered within agreed on timelines.
- Independently serve as the lead point of contact for all data management study-related communications.
- Actively participates in team meetings and presents Data Management concerns risks and issues.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.
- Bachelor’s degree or equivalent in life science, computer science, or related discipline.
- 8+ years of experience working within a pharmaceutical or CRO environment, with experience in managing Phase I, II or III studies, from start-up through closure.
- Demonstrated proficiency in various EDC Systems within the last 3 years.
- Demonstrated proficiency in the data management processes.
- Experience in managing external EDC vendors for Data Management.
- Understanding of Clinical Data Interchange Standards Consortium (CDISC), CDASH, and SAS® terminology.
- Understanding of the coding process and terms in MedDRA, WHODRUG and CTCAE.
- Thorough knowledge of applicable regulatory rules and guidelines.
- Excellent organizational skills and attention to detail.
- Effective communication and interpersonal skills.
- Able to set priorities and juggle multiple projects and demands.
- Able to think critically and independently and be a proactive problem-solver.
- Able to lead and work independently while exercising initiative, flexibility and sound judgment.
- Comfortable working with different levels of the company including senior level management.
- Demonstrated proficiency in Microsoft Word, Project, PowerPoint, Office, and Excel.
- Ability to operate in alignment with Pliant’s values.
Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).
The annual base salary for this role is $160,000 – $170,000. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.
To understand how Pliant complies with and manages your personal information with respect to the California Consumer Privacy Act, please visit https://pliantrx.com/ccpa-applicant-and-staff-privacy-notice/.
