Clinical Trial Manager

Pliant Therapeutics

South San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 06/02/2021
  • Website: pliantrx.com
  • Company Address: 260 Littlefield Avenue, South San Francisco, CA, 94080

About Pliant Therapeutics

Pliant Therapeutics is focused on discovering, developing and commercializing breakthrough treatments for fibrotic diseases.

By harnessing the therapeutic potential of integrin biology and TGF-β modulation, Pliant aims to prevent or even reverse fibrosis to address the needs of many patients. The company also aims to build a patient registry for certain areas of fibrotic disease to both increase understanding of natural disease progression, and fuel biomarker discovery.

Job Description

Pliant Therapeutics is a public, clinical 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 disease. The Company’s focus is on mechanism-based intervention in the fibrotic process using small molecules. The Company’s lead product candidate, PLN-74809, is an oral, small molecule selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration in both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC), and are currently in Phase 2a clinical trials for these indications. Pliant’s second product candidate, PLN-1474, is an oral, small molecule selective inhibitor of the αvβ1 integrin, in development as a potential treatment forlate-stage liver fibrosis under a partnership with Novartis. The Company also has discovery and development programs in oncology and muscular dystrophies. The Company is seeking passionate, creative, and dedicated individuals to join our team and contribute to our mission.

Description  

The Clinical Trial Manager is responsible for managing the day-to-day operations of assigned clinical studies to ensure completion per established project team goals and objectives.  The CTM will report to the VP, Clinical Operations and will work closely with a cross-functional team in a fast-paced high growth environment team to ensure that clinical trials are conducted on time and budget, and in accordance with applicable GCP/ICH guidelines and other regulatory requirements.  

Responsibilities

  • Lead internal cross-functional study team for assigned studies to identify risks and mitigation strategies.
  • Manage the day-to-day operations of assigned studies.
  • Manage clinical research organizations (CROs) to ensure timely and quality deliverables. 
  • Lead preparation of vendor requirements and project scope and selection of study vendors.
  • Lead feasibility assessment and selection of countries and sites for study conduct.  
  • Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data.
  • Oversee maintenance of clinical trial master files.
  • Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews.
  • Author, audit and/or edit written summaries of data reports, presentations, training material, and study documents (including pharmacy, laboratory, and operations manuals). 
  • Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members. 
  • Create and conduct study-specific training at investigator meetings. 
  • Review study invoices and participate in accrual reviews to track the financial status of the study against budget. 
  • All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs. 

Qualifications

  • Bachelor’s degree required. 
  • 7-10 years of experience (3-6 years of vendor and CRO management) in support of clinical trials in US and ex-US. 
  • Excellent organizational skills and attention to detail.
  • Effective communication and interpersonal skills.
  • Able to set priorities and juggle multiple demands.
  • Able to think critically and be a proactive problem-solver.
  • Able to 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, PowerPoint and Excel.
  • Ability to operate in alignment with Pliant’s values.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.