- Steer the execution of one or more of our early development clinical trials; from protocol development to achievement of corporate and study milestones such as first patient in, interim analysis, database lock, and study report completion.
- Manage external vendors including CROs, additional key vendors, and global investigative sites.
- Ensure adherence to study protocols, SOPs, ICH GCP guidelines by overseeing monitoring activities at investigative sites.
- Coordinate the development of study materials such as CRFs, ICFs, patient diaries.
- Act as the voice of Clinical Operations on cross-functional Clinical Development Teams.
- Partner with Clinical Operations and Clinical Science Team to build fit for purpose infrastructure and processes to support our expanding clinical development portfolio.
- A degree in a scientific discipline or health related field.
- Minimum of 4 years clinical research experience, including 2 years as a Clinical Trial Manager at a biopharmaceutical company or CRO.
- Experience with planning and executing Phase I-II trials is preferred.
- Demonstrated proficiency in implementing, monitoring, and management of clinical trials, from start-up to close-out.
- General knowledge of FDA regulatory requirements and ICH GCP guidelines.
- Strong organizational skills, ability to prioritize and multi-task.
- Excellent verbal and written communication skills.
- Demonstrated problem-solving and negotiation abilities.
- Ability to work as part of a team and build strong working relationships with internal and external partners.
- Capacity to roll-up sleeves to perform a broad range of clinical trial related tasks as needed.
- Willingness to travel as necessary, consistent with project needs.
- Excellent computer proficiency (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook).
- Experience with clinical trial databases (e.g., Medidata Rave, Veeva, etc.).
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Clinical Trial Manager - South San Francisco, United States - Maze Therapeutics
Description
Job Description
Job DescriptionThe Position:
Have you ever pictured yourself at the heart of groundbreaking clinical advancements? At Maze Therapeutics, we're looking for an experienced, highly motivated, and "hands-on" Clinical Trial Manager (CTM) to join our dynamic Clinical Operations Team.
As a CTM, you will be responsible for planning and managing our early development clinical trials in kidney disease while ensuring high quality data and timely clinical trial conduct per GCP standards. You will also collaborate with internal cross-functional groups at Maze to ensure that corporate and clinical trial related goals are met. We work with a sense of urgency to develop and deliver important precision medicines for patients, but we never compromise on the quality of clinical trial conduct and data as well as patient safety. This position will report to the Director, Clinical Operations, and you will have the support and guidance needed to excel in this critical role to make a lasting impact on the lives of patients.
Your Impact:
Skills and Qualifications:
About Maze Therapeutics
Maze Therapeutics is a biopharmaceutical company that is harnessing the power of human genetics to transform the lives of patients, with a focus on genetically informed therapies for common diseases, such as chronic kidney disease, and seeks to focus expertise and resources towards underserved communities. Maze applies variant functionalization in tandem with advanced data science methods and a robust suite of research and development capabilities to advance a pipeline of novel precision medicines. Maze has developed the Maze Compass PlatformTM, a proprietary, purpose-built platform to understand and integrate the critical step of variant functionalization into each stage of drug development. Utilizing the Maze Compass PlatformTM, Maze is building a broad portfolio of wholly owned and partnered programs. Its two lead programs are focused on Chronic Kidney Disease (CKD), a condition that impacts an estimated 37m individuals. The first program in CKD addresses a genetic subset of the common disease that has a disproportionate impact on the Black Community. Maze is based in South San Francisco.
Our People
Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.
Our Core Values
Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission.
Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.
Stand True – Our integrity is foundational; it guides us no matter the obstacle.
The expected annual salary range for employees located in the San Francisco Bay Area is $139,000 - $170,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.
Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.
