Department: Clinical Operations
Description: Pliant Therapeutics is a 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 for progress to meet unmet medical needs for patients and physicians. The company’s focus is on mechanism-based intervention in the fibrotic process using small molecules.
Position Overview: 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.
- 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.
- Bachelor’s degree required.
- 10 years of experience working with CROs to manage 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