Senior Clinical Trial Manager

Arbor-Biotechnologies-Inc; Cambridge (MA); On-site; USD 145,000 - 170,000; Full time

Job summary

Arbor Biotechnologies Inc in Cambridge, MA seeks a Senior Clinical Trial Manager to lead early-phase study execution from start-up to close-out. You will report to the Senior Director of Clinical Operations in a high-visibility role for novel gene editing therapeutics and ensure trials run on time, within budget, and to high quality standards.

You will manage study sites, external vendors, and cross-functional teams, drafting and reviewing clinical documents and plans while coordinating with

Qualifications

• Bachelor's degree required; 6+ years in clinical operations preferred.
• Experience leading early-phase studies in rare diseases beneficial.
• Strong knowledge of GCP, ICH guidelines, and regulatory submissions.

Responsibilities

• Oversee management of study sites and external vendors within budget and schedule per GCP/ICH.
• Develop budgets and timelines for assigned studies.
• Contribute to study plans, templates, and SOPs/WIs; review study protocols and essential documents.
• Manage cross-functional study teams and stakeholder relationships to meet milestones.
• Monitor lab sample transfers to sites and vendors; escalate issues as needed.
• Support safety reviews, DMC, and data cut timelines; maintain trial documentation.

Skills

Clinical operations

Early-phase trials

GCP ICH knowledge

Vendor management

Project management

Communication skills

Education

Bachelor's degree

Tools

Smartsheet

MS Office

Job description

Arbor Biotechnologies™ a next-generation gene editing company based in Cambridge, MA is advancing a pipeline of novel gene editing therapeutics to address a wide range of genetic conditions – from the ultra-rare to the most common genetic diseases. The company’s unique suite of optimized gene editors goes beyond the limitations of early editing technologies to unlock access to new gene targets and has fueled a robust pipeline of first-in-class assets focused on diseases of high unmet need. With Arbor’s lead program ABO-101 for the treatment of primary hyperoxaluria type 1 progressing into clinical trials the company continues to focus their research and development efforts on genomic diseases of the liver and CNS for which there are no existing functional cures. For more information please visit arbor.bio.

Who Are You?

You’re driven by purpose and fueled by curiosity. You take ownership think boldly and stay resilient through challenge. You lead with humility value diverse perspectives and put the success of the team above personal recognition.

About the Role:

The Senior Clinical Trial Manager will be at the forefront of our early phase studies. The role will report into the Senior Director of Clinical Operations and will be in a highly visible role for a novel class of gene editing therapeutics in rare genetic diseases. The role will be a key contributor to implementing and executing clinical trials from start-up to close-out. The role will be accountable for clinical trial management trial master file site monitoring study start-up activities and CRO management.

What You Can Expect:

• Overall responsibilityfor the management of clinical study sites and external vendors while adhering to budget scope and schedule requirements in accordance with GCP and ICH guidelines
• Develop and effectively manage budgets and timelines for assigned clinical studies
• Participate in the development clinical operations study plans study templates and SOP/WI
• Participate in creation and review of study protocols Informed Consent Forms (ICFs),Case Report Forms (CRFs), Statistical Analysis Plans (SAPs), Clinical Study Reports (CSRs) and other clinical documents to ensure seamless integration between clinical objectives and study performance
• Assist in management of cross functional study teams and establishing/maintaining key internal and external stakeholder relationships to ensure study milestones are met
• Track and oversee lab sample transfers from patients to sites to clinical lab vendors
• Proactively identify and resolve issues and manage escalation as appropriate
• Manage timelines for Safety Review Boards Data Monitoring Committee and Data Cuts
• Overseemaintenance of trial documentation and master file data validation andcompletion guidelines
• Participate in vendor review selection and negotiations
• Assist in planning and execution of Investigator Meetings as required Establish working relationships with clinical and internal and external medical experts to optimize and implement clinical studies
• Represent the company externally and travel to investigative sites as needed

What You Bring:

• Bachelor’s degree and 6+ years or relevant and progressive clinical operations experience working in the pharmaceutical and/or biotech industry preferably a mix of both
• Experience managing early-phase clinical studies in rare diseases
• Solid well-grounded experience in setup execution and operational management of US and global clinical trials delivered on time within budget and with high quality
• Experience in ethics and regulatory dossier submissions (e.g. pre-IND IND Scientific Advice CTA)
• Strong knowledge of GCP ICH drug development process and other relevant guidelines for clinical research activities
• Proven track record of experience working with CROs functional service providers and third-party vendors strong contract negotiation abilities and thorough understanding of all financial aspects of contracts
• Proficient project management skills (e.g. Smartsheet MS office or equivalent)
• Scientifically adept and great communication and interpersonal skills
• Knowledge of mRNA RNAi gene therapy or gene editing therapeutics and familiarity with LNP or AAV-based drug development
• Ability to work independently and collaboratively in a fast-paced matrixed team environment consisting of internal and external team members
• Excellent planning organization and time management skills
• Motivated individuals who want to roll up their sleeves and apply drug development knowledge and experience to develop gene-editing therapies in a startup environment
• Flexibility to travel domestically and internationally as required

Our Values:

• Purposeful Action: Driven by outcomes guided by purpose
• Bold Resilience: Speak boldly embrace change grow forward
• Humble Authenticity: Be real value the uniqueness of others elevate all

The anticipated salary range for candidates for this role will be $145,000 - $170,000. The final salary offered will depend on several factors which may include but not limited to relevant years of experience educational background industry knowledge technical skills and other factors that may prove relevant during the interview process.

We promote diversity and inclusion not just in our recruitment processes but in everything we do. We’re an equal opportunity employer and we will continue to ensure our recruitment process is free of bias and our workplace is inclusive positive and free of discrimination and respecting of all backgrounds and beliefs.