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 an Associate Director, Director or Senior Director of 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

• Manage the day-to-day operations of assigned studies or specific study deliverables as directed by the program lead.
• Manage clinical research organizations (CROs), central labs, and/or other vendors (eg, imaging, ECG, specialty labs) to ensure timely and quality deliverables.
• Perform monitoring oversight, as needed.
• Identify risks and mitigation strategies on assigned studies.
• Implement appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors, and data.
• Oversee assigned studies through review of monitoring visit reports and Trial Master File QC reports.
• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews.
• Author, review and/or edit written summaries of data reports, presentations, training materials, study plans, study manuals (pharmacy, laboratory), and other study documents.
• Develop investigator and site monitor training materials for study start-up and maintenance.
• Review vendor work orders, change orders, and invoices and participate in accrual reviews to track the financial status of the study against budget.
• 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.
• 6 - 10 years of experience (3-6 years of vendor and CRO management) in support of clinical trials.
• Excellent organizational and time management skills.
• 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.
• Ability to identify and provide solution to logistical problems.
• Ability to efficiently perform multiple tasks and manage changing priorities.
• Able to work independently while exercising initiative, flexibility and sound judgment.
• Comfortable working with different levels of the company including senior level management.
• Ability to read and understand regulatory documents and Standard Operating Procedures.
• Demonstrated proficiency in Microsoft Word, PowerPoint and Excel.
• Takes direction well.
• Ability to operate in alignment with Pliant's values.