Clinical Trial Manager

Clinical Dynamix; United States; On-site; USD 130,000 - 145,000; Full time

Job summary

Join a forward-thinking company focused on oncology drug discovery as a Clinical Trial Manager. You will play a pivotal role in overseeing complex clinical trials, ensuring compliance with regulatory standards, and managing vendor relationships. This position offers the opportunity to work with a talented team dedicated to bringing innovative therapies to patients in need. If you have a passion for clinical research and a strong background in trial management, this role is perfect for you. Embrace the chance to make a significant impact in the fight against cancer while advancing your career in a dynamic environment.

Qualifications

• 5+ years of experience in clinical trial management.
• Knowledge of ICH-GCP, FDA, and EMA regulatory requirements.

Responsibilities

• Oversee day-to-day operations of Phase I-III oncology trials.
• Ensure compliance with regulatory guidelines and manage CRO activities.

Skills

Clinical Trial Management

Regulatory Compliance (FDA, EMA, ICH-GCP)

Data Management

Communication Skills

Organizational Skills

Risk Management

Education

Bachelor's in Life Sciences

Tools

Electronic Data Capture (EDC) Systems

Job description

This range is provided by Clinical Dynamix. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$130,000.00/yr - $145,000.00/yr

Clinical Trial Manager Job Description:

Company Overview:

Company is an oncology-focused small molecule drug discovery and development company adopting a capital-efficient approach to bring novel therapies to patients in need. Our experienced management team and world-class scientists work to advance promising drugs and therapeutic technologies that we believe can help conquer cancer.

Position Summary:

Reporting to the Director of Clinical Operations, this manager’s role is responsible for hands-on oversight of the day-to-day operations of complex Phase I-III clinical oncology trials. Including CRO and vendor management (trial management, central lab, supply chain/depot), data review and management, and sponsor trial oversight activities (monitoring report review, protocol deviation review, routine TMF monitoring, and sponsor quality site visits).

Primary Responsibilities

• Ensure clinical trial compliance with protocol, FDA, EMA, ICH-GCP, and other relevant regulatory guidelines
• Management of day-to-day CRO activities, including oversight of patient and site management, site monitoring, clinical Trial Master File (TMF) maintenance, and adherence to CRO plans, SOPs and trial manuals (lab and pharmacy)
• Work closely with CRO data and site management to ensure accurate and timely data collection, source data verification, query resolution and data review; including oversight of clean patient tracker
• Support Company clinical scientist to review case report forms, evaluate clinical data, and ensure its integrity and accuracy
• Oversight of CRO and vendor budgets to ensure work is completed within the scope of the approved work order and invoices are accurate
• Ensure that all adverse events are reported promptly and accurately to the relevant authorities
• Identify and mitigate potential risks that could impact trial participate safety, trial timelines, data quality, or compliance, and escalate as appropriate
• Support cross-functional teams by organizing meetings, preparing agendas, and documenting action items and decisions made

Position Qualifications and Experience

• Bachelors in life sciences preferred
• Oncology experience preferred
• Experience in managing Phase I-III clinical trials preferred
• Minimum of 5+ years of experience in clinical trial management within the pharmaceutical, biotechnology, or CRO industries. May consider Associate Clinical Trial Manager with fewer than 5 years’ experience.
• Knowledge of ICH-GCP, FDA, and EMA regulatory requirements
• Experience working with and navigating electronic data capture (EDC) systems
• Strong communication and organizational skills
• Experience in site monitoring is a plus
• Ability to work in a small remote team-oriented environment

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research and Science

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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