Central Monitoring Associate (CMA)

About Summit:

Ivonescimab known as SMT112 is a novel potential first-in-class investigational

bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC) with three active Phase III trials:

• HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g. osimertinib).

• HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

• HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

Overview of Role:

The Central Monitoring Associate (CMA) supports the execution of centralized and risk-based monitoring (CRBM) strategies at Summit Therapeutics. This role involves evaluating site performance data integrity and proactively identifying and mitigating risks to enhance trial execution. The associate will define acceptable ranges and data review processes with input from cross-functional team detect and escalate risk signals participate in data cleaning and contribute to CRBM strategy across Summits clinical programs. Ideal candidates have 2 years of clinical research experience with a strong background in late-phase oncology trials.

Role and Responsibilities:

• Conduct monthly reviews of Key Risk Indicators (KRIs) Quality Tolerance Limits (QTLs) and other operational health measures across active studies.
• Supports the Senior Manager CRBM in conducting protocol risk assessments and developing mitigation plans.
• Review statistical analysis and data visualizations per central monitoring plan to identify unusual patterns trends outliers or emerging risks.
• Evaluate impact of data integrity issues including delays in data entry missing/outlier data and protocol revisions.
• Translate data trends into actionable insights and recommend mitigations for study stakeholders.
• Apply critical thinking to interpret complex data and design meaningful visualizations to translate observations beyond data points and understand overall study impact.
• Coordinate cross-functional review meetings with Clinical Operations Biostatistics Safety and Data Management teams.
• Collaborate with internal teams and external vendors to ensure seamless data integration and traceability of risk signals.
• Provide input on CRBM process improvement including standardization of templates documentation practices alignment with regulatory requirements operational excellence and inspection readiness.
• Ensure all central monitoring review documentation is complete filed in the Trial Master File (TMF) and ready for regulatory or internal audits.
• Additional duties as assigned.

Experience Education and Specialized Knowledge and Skills:

• Bachelors degree in Life Sciences Clinical Research Nursing Computer/Data Sciences or a related field is preferred.
• Minimum 2 years of experience in clinical trial monitoring or equivalent.
• Demonstrated knowledge in central monitoring clinical data review quality assurance or clinical operations.
• Hands-on experience with clinical trial processes Good Clinical Practice (GCP) Risk-Based Monitoring and regulatory requirements.
• Proficiency in computer applications and data analysis tools (e.g. Excel Smartsheet MS365) is essential.
• Experienced in clinical data review data cleaning and trend analysis with preferred experience in late-phase oncology trials and strong analytical problem-solving abilities.
• Agile learner with proven ability to rapidly work in dynamic systems with evolving processes with resilience and adaptability.
• Detail-oriented with the ability to time manage multiple priorities and projects.
• Effective communicator with a collaborative and problem-solving mindset for cross-functional teamwork.

Good to have-

• Certification in Clinical Research (e.g. CCRP CCRA) or related field.
• Familiarity with clinical data management systems (e.g. EDC CTMS) and end-to-end data capture and review for submission packages.

The pay range for this role is $77000-$91000 annually. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.