Manager, Clinical Operations

SanegeneBio Inc.; Woburn (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

A pioneering biotechnology company in Woburn is seeking an experienced Clinical Operations Manager to oversee clinical trials in nephropathies. The ideal applicant will have over 10 years of experience, strong project management skills, and a detail-oriented approach. Responsibilities include managing trial protocols, site selection, and regulatory compliance. Join us to revolutionize therapies with RNAi technology. Interested candidates can send applications to [e-mail].

Qualifications

• 10+ years of experience in clinical operations, preferably in nephropathies.
• Proven track record in trial management and regulatory compliance.

Responsibilities

• Lead the planning, execution, and monitoring of clinical trials focused on nephropathies.
• Develop and implement clinical trial protocols and informed consent forms.
• Coordinate with cross-functional teams for efficient trial execution.
• Identify and manage clinical trial sites.
• Conduct site visits to monitor trial progress.
• Oversee data collection processes and prepare trial updates.
• Ensure compliance with FDA, EMA, and ICH guidelines.
• Assist in developing and managing clinical trial budgets.

Skills

Project management

Organizational skills

Problem-solving

Communication skills

Collaboration

Detail-oriented

Education

Bachelor’s degree in life sciences, nursing, or related field

Master's degree (preferred)

Tools

Clinical trial management software

Data analysis tools

Job description

We are seeking a highly organized and experienced Clinical Operations Manager to join our dynamic clinical research team. The ideal candidate will possess a robust background in managing clinical trials, particularly in the areas of nephropathies, including IgA Nephropathy (IgAN), C3 Glomerulopathy (C3G), and other related kidney diseases. This role will involve overseeing the planning, execution, and management of clinical trials, ensuring compliance with regulatory requirements, and maintaining high standards of quality throughout the trial lifecycle.

Key Responsibilities

Clinical Trial Management:

• Lead the planning, execution, and monitoring of clinical trials focused on nephropathies, ensuring that all activities align with the study protocol, timelines, and budgetary constraints.
• Develop and implement comprehensive clinical trial protocols, informed consent forms, and case report forms, ensuring clarity and compliance with Good Clinical Practice (GCP) and regulatory guidelines.
• Coordinate with cross-functional teams to ensure that all aspects of the trial are executed efficiently, including site selection, patient recruitment, and data collection.

Site Management and Monitoring:

• Identify, select, and manage clinical trial sites, ensuring that sites are adequately trained and equipped to conduct the trials effectively.
• Conduct regular site visits to monitor trial progress, assess site performance, and ensure compliance with study protocols and regulatory requirements.
• Address any site-related issues promptly and implement corrective actions as necessary to maintain trial integrity.

Collaboration with Cross-Functional Teams::

• Work closely with clinical research associates, data management, regulatory affairs, and medical affairs teams to facilitate seamless trial execution and data integrity.
• Foster strong relationships with investigators, site staff, and key opinion leaders in nephropathies.

Data Management and Reporting:

• Oversee data collection processes to ensure the accuracy, completeness, and integrity of clinical trial data.
• Prepare and present trial updates, interim analyses, and final reports to stakeholders.
• Collaborate with biostatisticians to ensure appropriate statistical methodologies are applied to study design and data analysis.

Regulatory Compliance:

• Ensure that all clinical operations activities comply with FDA, EMA, ICH guidelines, and company policies.
• Support regulatory submissions (INDs, NDAs) and respond to regulatory inquiries as needed.

Budget Management:

• Assist in developing and managing clinical trial budgets.
• Ensure accurate tracking of expenditures and timely payments to sites/vendors.

Qualifications

Education:

• Bachelor’s degree in life sciences, nursing, or a related field (MS preferred).

Experience:

• 10+ years of experience in clinical operations (nephropathy experience preferred).
• Proven track record in trial management, site monitoring, and regulatory compliance.

Skills & Attributes:

• Strong project management, organizational, and problem-solving skills.
• Proficient in clinical trial management software and data analysis tools.
• Excellent communication and collaboration skills.
• Detail-oriented, proactive, and able to manage multiple projects effectively.

If you are interested in joining our team that is revolutionizing therapies for metabolic and autoimmune diseases with RNAi technology, please send your information to [e-mail] .