We are a dynamic and rapidly growing biotechnology company specializing in cutting-edge oncology research and development. Our mission is to revolutionize cancer treatment and improve patient outcomes by leveraging innovative therapies and breakthrough discoveries. With a passionate team of scientists, clinicians, and industry experts, we are committed to making a meaningful impact in the fight against cancer.
We are seeking a highly skilled and motivated Senior Clinical Trial Manager to join our dedicated team. In this critical role, you will be responsible for managing the planning, execution, and oversight of our oncology clinical trials. As a key member of the clinical operations team, you will collaborate closely with cross-functional stakeholders, investigators, and contract research organizations (CROs) to ensure successful trial delivery and adherence to quality standards and timelines.
- Lead and oversee the end-to-end execution of clinical trials, including trial planning, site selection, budget management, and trial closeout activities.
- Collaborate with internal teams to develop and implement comprehensive clinical trial strategies, protocols, and operational plans.
- Manage and oversee CROs, vendors, and other external partners to ensure high-quality deliverables, adherence to study timelines, and compliance with regulatory requirements.
- Monitor trial progress, identify potential issues, and implement corrective actions to mitigate risks and ensure trial milestones are achieved.
- Maintain effective communication and collaboration with investigators, study coordinators, and site staff to ensure successful site activation, patient recruitment, and enrollment.
- Ensure compliance with applicable regulatory guidelines, ICH-GCP, and company SOPs throughout all aspects of clinical trial conduct.
- Drive continuous process improvement initiatives to enhance operational efficiency and optimize trial execution.
- Contribute to the development and review of study-related documents, including protocols, informed consent forms, study manuals, and clinical study reports.
- Provide mentorship and guidance to junior members of the clinical operations team.
- Bachelor's degree in life sciences or a related field. Advanced degree is a plus.
- Minimum of 5 years of experience in clinical trial management within the biotechnology, pharmaceutical, or CRO industry, with a focus on oncology trials.
- Strong knowledge of clinical trial regulations, ICH-GCP guidelines, and FDA/EMA requirements.
- Proven experience in managing multiple Phase II/III clinical trials simultaneously.
- Demonstrated ability to lead cross-functional teams and manage external vendors and CROs effectively.
- Excellent organizational and project management skills, with a keen attention to detail and ability to prioritize tasks.
- Strong problem-solving and decision-making abilities, with a proactive and solution-oriented mindset.
- Excellent communication and interpersonal skills, with the ability to build effective relationships with internal and external stakeholders.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) platforms.