Manager, Clinical Research Operations

This is a regular, full-time, on-site position based at our New Haven, Connecticut facility.

The Manager, Clinical Research Operations plays a critical role in supporting the successful execution of clinical trials at the New Haven, CT research site. This position oversees the coordination of cross-functional project activities, ensuring operational efficiency, protocol compliance, and high-quality study delivery. Serving as a key liaison between internal and external teams such as, sponsors, CROs, and vendors, the Manager drives start-up readiness, operational planning, training development, and ongoing study oversight. This role requires strong clinical project management capabilities, deep knowledge of clinical research regulations, and the ability to anticipate challenges in a fast-paced, clinical environment. The ideal candidate brings strategic insight, exceptional communication skills, and a collaborative, solutions-focused approach to advancing the site's clinical research portfolio.

About Mitro

MITRO Biotech Co., Ltd. is a molecular imaging contract research organization (MI-CRO) company in China. MITRO provides outstanding contract research for new drug development using radiolabeling and molecular imaging techniques. MITRO provides integrated solutions, including evaluation of potential therapeutics, biodistribution, pharmacokinetics and pharmacodynamics. MITRO provides translational research using a wide range of non-clinical through Phase 0 clinical trial services. MITRO's focus includes but is not limited to: cancer, coronary heart disease, Alzheimer disease, epilepsy, Parkinson disease, rheumatoid arthritis, diabetes, gene expression, and stem cell research.

MITRO Biotech Co., Ltd.'s acquisition of XingImaging, LLC in September 2023 brought with it an active expansion to offer early through late phase PET clinical imaging and clinical services to industry sponsors and researchers for advancement of new imaging tracers for evaluation of diagnostic indicators, disease progression, and therapeutic medicines.

Key Responsibilities:

· Partner with the clinical research management team to oversee and integrate all project activities at the New Haven, CT clinical site, effectively leveraging internal expertise and external collaborators to enhance operational efficiency and study outcomes.

· Contribute to the development and refinement of trial-level operational strategies to ensure high-quality clinical execution.

· Provide strategic insight and support for participant recruitment planning and implementation.

· Serve as the primary operational point of contact for the clinical site, fostering strong, solution-oriented relationships with sponsors, CROs, and external vendors.

· Supports the clinical operations team with vendor management activities, including the initiation and onboarding of new vendors in partnership with the Quality Assurance team.

· Review and advise on study budgets, timelines, resource allocation, and forecasting for assigned clinical trials.

· Support the creation and maintenance of comprehensive study start-up and amendment training materials, including SIV and KOM presentations, in addition to compound- and protocol-specific training resources.

· Supports clinic study leads in scheduling and coordinating study start-up activities, including protocol reviews, required trainings, SIV and KOM planning, mock visit/dry run scheduling, and post-visit debriefs as needed.

· Track and monitor study progress to ensure adherence to timelines, protocols, regulatory requirements, and quality standards.

· Draft, revise, and maintain Standard Operating Procedures (SOPs) and related operational documentation to support compliant, efficient, and scalable clinical research processes.

· Collaborate closely with internal stakeholders - including Clinical Research, Imaging Services, Business Operations, Legal, Finance, Project Management, Vendor Management, Quality Assurance, Regulatory Affairs, Data Management, Chemistry, and senior leadership; often serving as a liaison to streamline communication and optimize cross-functional workflows.

· Coordinate sponsor-led initiation visits and support the site's readiness for audits, inspections, risk identification, and mitigation activities.

· Perform additional duties as assigned by the direct supervisor and/or Clinic Management.

Qualifications and Requirements:

• Bachelor's degree with 7–10 years of experience, or Master's degree with 5+ years of experience managing projects for complex initiatives in a clinical research environment and within a matrixed organization.

• Background in clinical operations or clinical project management.

• Strong understanding of GCP, ICH, and applicable regulatory requirements.

• Proactive, solutions-oriented mindset with the ability to prioritize and anticipate challenges.

• Strong analytical, decision-making, and financial management capabilities.

• Demonstrated ability to drive team productivity and work independently.

• Exceptional organizational, critical reasoning, and problem-solving skills with the ability to manage competing priorities.

• Excellent project management, written and verbal communication, and presentation skills.

• Experience developing or reviewing protocols, ICFs, CRFs, and SOPs.

Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook, Teams).

Preferred but not required:

• Experience supporting clinical trials in neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, Multiple Sclerosis, or related tauopathies.

• Familiarity with nuclear medicine imaging modalities, including PET-CT, SPECT-CT, and MRI.

• Experience in clinical operations for early-phase clinical trials.

• Certification in Project Management and/or related discipline preferred; certification in a clinical research profession or related field is a plus.

Unique Department Requirements:

• Exposure to ionizing radiation

• Biohazard exposure to human blood and bodily fluids

• Ability to lift and move up to 50 lbs (for heavy equipment and patient positioning)

• Intermittent evening and weekend work may be required

• Travel to meetings may be required

PLEASE NOTE:

Please note that since this is position is fully onsite, in the case of epidemic or other health crisis, employee must be willing to take reasonable steps to ensure that bacterial and viral infections are not spread to others including but not limited to temperature checks, vaccinations, exclusion from the office building, and other precautions as required by the building's landlord.

What We Offer:

· Competitive Salary

· Comprehensive Health Insurance Plan

· Long-Term Disability

· Life Insurance

· Retirement Plan

XingImaging, a Mitro Company provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic information, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Equal employment opportunity applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation, and training