Clinical Trial Manager II

Summit Therapeutics Inc.; Miami (FL, NJ); Presencial; USD 122.000 - 145.000; Jornada completa

Descripción de la vacante

Summit Therapeutics Inc. seeks an experienced Clinical Trial Manager 2 to lead global trial management for Phase II/III oncology programs. You will coordinate site activation, monitoring, data handling and safety oversight while partnering with CROs to optimize patient enrollment and regulatory compliance.

The role requires 6+ years in CTM roles, oncology experience, and willingness to travel up to 20%. Excellent planning, leadership and communication are essential in a fast-paced,

Formación

• 6+ years of clinical trial management experience in conducting international trials.
• 5+ years of direct CTM experience including oversight Phase II/III trials; global oncology preferred.
• Ability to travel internationally to visit clinical sites and study meetings (up to 20%).
• Demonstrated ability to comprehend complex scientific concepts and review/assess clinical data.
• Excellent planning, time management, and project coordination skills.
• Works independently and collaboratively in fast-paced environments with sound judgment.

Responsabilidades

• Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities.
• Partners with the CRO to ensure robust trial execution, data monitoring strategies, and patient enrollment strategies.
• Drafts, reviews and manages study plans, ICFs, CTAs, CRFs, monitoring plans, data management, and safety monitoring.
• Reviews and approves essential document packages.
• Tracks and resolves Risk Based Quality Management actions and signals.
• Oversight of CRO monitoring activities; reviews monitoring reports and site performance.
• Performs quality oversight visits and TMF maintenance reviews.
• Ensures compliance with Good Clinical Practices and regulatory requirements; inspection readiness.
• Mentors CTMs, CRAs, and other Clinical Operations team members.
• All other duties as assigned.

Conocimientos

Clinical trial management

GCP/ICH knowledge

Project coordination

Global oncology experience

Regulatory compliance

Mentoring

Travel readiness

Educación

Bachelor's degree or equivalent in life science/health field

Descripción del empleo

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:

Non-small Cell Lung Cancer (NSCLC)

HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role:

The Clinical Trial Manager 2(CTM2) is an experienced clinical operations professional accountable for all aspects of Clinical Trial Management for global studies. The CTM2 is accountable for study start up and maintenance through study close out, coordinates, leads and drives deliverables for assigned sites, countries, or regions for one or more studies or programs simultaneously. The CTM2s are also accountable for site, country, or region performance metrics and quality of deliverables in the clinical trial.

Role and Responsibilities:

• Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities.
• Partners with the CRO to ensure robust clinical trial execution, data monitoring strategies, and patient enrollment strategies.
• Drafts, reviews and manages study related plans, processes including Informed Consent Forms, Investigator agreements (CTA), CRFs, CRF guidelines, statistical/pharmacokinetic analysis plans, monitoring plan, data management, and safety monitoring as delegated.
• Reviews and approves essential document packages.
• Tracks and ensures resolution of Risk Based Quality Management actions and signals.
• Conducts sponsor oversight of CRO monitoring activities by reviewing all types of monitoring reports; monitors site performance, identifies quality trends, and ensures timely resolution of monitoring findings and action items.
• Performs quality oversight visits.
• Reviews clinical data listings, reports and dashboards ensuring data currency and completeness inclusive of laboratory, imaging and other protocol required assessments.
• Identifies trends and follows up on outstanding data issues with CRO and Study team.
• Responsible for oversight on the maintenance and completeness of the TMF, performing periodic quality reviews.
• Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements.
• Ensures inspection readiness.
• Mentors and provides guidance to CTMs, CRAs, and other Clinical Operations team members.
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
• 6+ years of clinical trial management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
• 5+ years of direct clinical trial management experience including oversight phase II/III clinical trials. Global oncology experience preferred.
• Ability to travel internationally to visit clinical sites and study meetings. Amount will vary upon project needs (up to 20%)
• Demonstrated ability to comprehend complex scientific concepts and proficient in reviewing and assessing clinical data.
• Possesses excellent planning, time management, and project coordination skills.
• Demonstrated ability to identify and manage operational risks and develop effective mitigation strategies.
• Ability to work independently and collaboratively to manage and prioritize work in a fast-paced environment
• Consistently demonstrates the ability to solve problems and use sound judgement in relation to regulatory requirements, interactions with external parties, timelines, and moderately to high clinical programs.
• Strong planning, communication, and organizational skills.
• A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process

This is the pay for this position

Pay Transparency

$122,000 - $145,000 USD

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 Summit’s Talent Acquisition team [e-mail] to obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics Inc.is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.