The Senior 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 Sr. CTM 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.
• Review and edit of relevant documents including protocols, informed consent forms, case report forms
• Coordinate clinical study timelines with Project Management and escalate issues that may impact timelines/deliverables.
• Manage clinical research organizations (CROs) and oversee management of other vendors 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 study plans/procedures/guidelines and ensure their timely implementation.
• 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.
• Assists with Inspection Readiness activities which may require development, modification and/or implementation of policies as needed to ensure high quality and integrity.
• 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

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 required.
• 8+ years of experience, including CRO management in support of global clinical programs.
• 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.
• Experience managing or mentoring junior-level Clinical Operations or administrative staff
• Comfortable working with different levels of the company including senior level management.
• Demonstrated proficiency in Microsoft Word, PowerPoint and Excel.

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 $165,000 – $175,000. 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.