Clinical Trial Manager

MBX Biosciences, Inc.; Indiana (PA); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a proactive Clinical Trial Manager to join their Clinical Operations team. This role emphasizes early-phase clinical development, where you will be the key liaison between the company and clinical trial sites. Your expertise will foster strong relationships and ensure high-quality trial execution, directly impacting the success of innovative therapies. With opportunities for career growth, you will manage early-phase programs and contribute to the expansion of a promising clinical pipeline. If you are passionate about advancing healthcare through clinical research, this position offers a dynamic and rewarding environment.

Qualifications

• 8+ years of clinical experience with a focus on early-phase clinical development.
• Strong understanding of drug development from Phase I to Phase III.
• Prior team management experience preferred.

Responsibilities

• Serve as primary contact for study sites, ensuring compliance and data integrity.
• Lead development of regulatory documents and support study startup activities.
• Oversee site monitoring and maintain essential regulatory documents.

Skills

Clinical Trial Management

Regulatory Compliance

Site Management

CRO/Vendor Management

Team Leadership

Project Communication

Data Integrity

Organizational Skills

Education

Bachelor's Degree

Tools

Smartsheet

TMF Systems

Job description

We are seeking a proactive and experienced Clinical Trial Manager to join our Clinical Operations team, with a focus on early-phase clinical development. In this critical role, you will serve as the primary liaison between MBX and clinical trial sites, fostering strong, collaborative relationships that ensure high-quality trial execution and accelerate early-phase program success. As a site-facing representative, you will play a key role in supporting clinical sites through startup, enrollment, data integrity, and compliance processes. Your ability to identify and remove operational barriers will directly contribute to the timely and effective execution of our early-phase studies. You will be responsible for managing our early-phase programs, with the opportunity to take on additional projects as our clinical pipeline expands. This position offers strong career growth potential as MBX scales its infrastructure to support a growing portfolio of early-stage assets.

Key Responsibilities

• Serves as the primary point of contact for assigned study sites, CROs, and vendors, effectively communicating project updates, addressing inquiries, and resolving issues in alignment with the CTM escalation pathway.
• Leads or contributes to the development and review of regulatory documentation to support study start-up activities, ensuring site readiness and availability of necessary supplies for site initiation visits (SIVs).
• Prepares and presents materials for Investigator Meetings and site-specific training, participating as needed to ensure consistent messaging and study understanding across stakeholders.
• Executes all clinical trial activities in full compliance with internal SOPs, FDA regulations, and ICH-GCP guidelines.
• Independently supports operational execution across multiple clinical studies, prioritizing subject safety and the integrity and accuracy of clinical data.
• Collaborate with the Clinical Research Associates to maintain essential regulatory documents and study supplies throughout the lifecycle of assigned trials.
• Conducts and/or oversees all phases of site monitoring—including pre-study visits (PSVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and close-out visits (COVs)—either independently or in coordination with CRO partners.
• Maintains and monitors study tracking tools to ensure up-to-date status reporting of clinical trial documents (e.g., protocols, Investigator Brochures) and proactively follows up to retrieve outstanding materials.
• Provides leadership and oversight to direct and indirect reports, where applicable, including responsibilities such as recruitment, training, performance management, coaching, and professional development following company policies.
• Performs additional responsibilities and cross-functional support as required to ensure the success of clinical programs.

Education& Qualifications

• Bachelor's degree with 8+ years of clinical experience.
• 7+ years of direct experience with clinical site management, CRO/Vendor management, and logistical execution of clinical trials.
• Experience working in a small company in the biotech or pharmaceutical industry is preferred.
• Prior team management experience (direct or indirect).
• Experience with Smartsheet and TMF systems.
• Strong understanding of clinical trials, drug development, Phase I through Phase III
• Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.

Company Overview:

MBX Biosciences, Inc. (NASDAQ: MBX) is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. The Company was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide (PEP) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow us on LinkedIn.

EEO Statement:

MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.

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