Clinical Trial Manager

About the role

As a Clinical Trial Manager at Bamboohr, you will play a pivotal role in overseeing the planning, execution, and management of clinical trials. Your expertise will ensure that trials are conducted efficiently, adhering to regulatory standards and timelines. You will collaborate with cross-functional teams, including clinical operations, data management, and regulatory affairs, to drive the successful delivery of clinical projects. This position offers an exciting opportunity to contribute to innovative therapies in the biotech sector while working in a dynamic and supportive environment.

Key facts

What you'll do

• Lead the planning and execution of clinical trials, ensuring compliance with regulatory requirements and adherence to Good Clinical Practice (GCP) guidelines.
• Develop and manage study timelines, budgets, and resources to ensure successful trial delivery.
• Coordinate with clinical sites, investigators, and vendors to facilitate smooth trial operations and address any issues that arise.
• Monitor trial progress and performance metrics, implementing corrective actions as necessary to maintain project timelines.
• Prepare and review study-related documents, including protocols, informed consent forms, and case report forms, ensuring accuracy and completeness.
• Conduct regular meetings with internal teams and external partners to communicate updates, share insights, and align on project goals.
• Oversee data collection and management processes, ensuring high-quality data is captured and reported in a timely manner.
• Collaborate with regulatory affairs to prepare submissions and maintain compliance with local and international regulations.
• Provide training and support to clinical trial staff and site personnel, fostering a culture of excellence and continuous improvement.
• Participate in the selection and management of clinical research vendors, ensuring they meet the required standards and deliverables.
• Analyze trial data and prepare reports for stakeholders, summarizing findings and recommending next steps based on results.
• Stay updated on industry trends, advancements, and best practices to enhance trial management processes and outcomes.

Requirements

• Bachelor's degree in life sciences, nursing, or a related field; advanced degree preferred.
• Minimum of 5 years of experience in clinical trial management within the biotechnology or pharmaceutical industry.
• Proven track record of managing multiple clinical trials simultaneously, with a strong understanding of the clinical development process.
• In-depth knowledge of GCP, FDA regulations, and ICH guidelines.
• Exceptional organizational skills with the ability to prioritize tasks and meet deadlines in a fast-paced environment.
• Strong interpersonal and communication skills, capable of working collaboratively with diverse teams and stakeholders.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
• Ability to analyze complex data sets and generate actionable insights.
• Detail-oriented mindset with a commitment to maintaining high-quality standards in all aspects of trial management.

Nice to have

• Experience in rare disease or oncology clinical trials is a plus.
• Familiarity with project management software and tools.
• Certification in clinical research (e.g., ACRP, SOCRA) is advantageous.
• Previous experience working with international clinical trials and regulatory submissions.

Skills & tools

• Strong project management skills, including the ability to develop and manage project plans, timelines, and budgets.
• Excellent analytical skills, with the ability to interpret complex data and make informed decisions.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and other relevant software applications.
• Familiarity with statistical analysis software is a plus.
• Strong problem-solving abilities and a proactive approach to identifying and addressing challenges.

Practical notes

• This position is based in South San Francisco, California, and may require occasional travel to clinical sites.
• Bamboohr is committed to fostering a diverse and inclusive work environment, encouraging applicants from all backgrounds to apply.
• The salary for this role will be competitive and commensurate with experience, reflecting the value you bring to the team.
• Interested candidates are encouraged to apply through the Bamboohr career portal at [Apply URL](https://structuretx.bamboohr.com/careers/391).

Join Bamboohr as a Clinical Trial Manager and be part of a team that is dedicated to advancing groundbreaking therapies that can change lives. Your expertise will be instrumental in shaping the future of clinical research and improving patient outcomes.