Clinical Trial Manager/Senior Clinical Trial Manager
Clinical Trial Manager/Senior Clinical Trial Manager
Boston, MA
$160,000 - $180,000
Job Description
We are partnered with a growing, privately backed biotechnology organization focused on advancing innovative therapeutic programs. The company is expanding its clinical development capabilities and is seeking a Senior Clinical Trial Manager to play a key role in the execution of multiple ongoing and planned clinical studies.
This is an opportunity to join a well-resourced, science-driven team at an exciting stage of development, offering meaningful ownership, cross-functional visibility, and long-term growth potential within clinical operations.
Key Qualifications
* Demonstrated experience managing clinical trials within the biopharmaceutical or biotechnology industry, with a strong focus on complex therapeutic areas such as oncology or related specialties.
* Deep understanding of clinical trial operations, including protocol execution, site oversight, patient enrollment strategies, and ongoing trial monitoring.
* Strong working knowledge of ICH-GCP, FDA regulations, and global clinical trial guidelines, with a proven ability to ensure compliance throughout the trial lifecycle.
* Extensive experience collaborating with investigational sites, CRO partners, and vendors, with a track record of improving site performance and study execution.
* Proven ability to oversee clinical data review activities, including source data verification and issue resolution, ensuring data quality and integrity.
* Excellent communication and organizational skills, with the ability to manage multiple priorities in a fast-paced environment.
Roles & Responsibilities
* Lead the planning, start-up, execution, and close-out of assigned clinical trials, ensuring adherence to protocols, timelines, budgets, and regulatory requirements.
* Serve as the primary point of contact for investigational sites, providing guidance, problem-solving support, and ongoing oversight to drive successful trial outcomes.
* Partner closely with CROs and internal stakeholders to ensure high-quality trial conduct, effective monitoring strategies, and proactive issue resolution.
* Oversee data review processes, including ongoing data cleaning activities and source data verification, to maintain the accuracy and reliability of clinical trial data.
* Ensure all clinical trial activities are conducted in compliance with applicable regulatory standards and ethical guidelines, escalating risks and issues as needed.
* Identify potential operational risks and develop mitigation strategies to keep studies on track and aligned with program timelines.
* Contribute to continuous improvement initiatives within clinical operations, supporting process optimization and best practices.
Benefits
* Comprehensive medical, dental, and vision coverage
* 401(k) with company contribution
* Generous PTO and paid holidays