Sr. Clinical Trial Associate

About Summit:

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. Summits 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.

Summits team is inspired to touch and help change lives through Summits 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.

Colorectal Cancer (CRC)

• 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 Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland.

SENIOR CLINICAL TRIAL ASSOCIATE

Location: ONSITE - Princeton NJ

Overview of Role:

The Senior Clinical Trial Associate (Senior CTA) is an experienced clinical operations professional who is responsible for supporting the daily workflow of clinical operations activities. They will provide robust administrative support to study teams throughout the study. Key administrative activities include but are not limited to managing meeting invitations creating agendas and meeting minutes study document filing maintaining study trackers and oversight of the eTMF and vendors.

Role and Responsibilities:

• Provides comprehensive administrative support to the clinical operations study teamincluding managing meeting logistics creating agendas and drafting meeting minutes withminimal oversite
• Executes tasks as assigned by the Clinical Operations Manager including study budgetforecasting and tracking
• Ensures accurate and timely documentation including eTMF management study contractsand financial records in compliance with ICH-GCP company policies and regulatoryrequirements
• Coordinates clinical operations activities across cross-functional teams including contractmanagement vendor oversight site start-up and activation protocol deviation
• Creates and maintains study-related materials such as country and site binders and trackstrial milestones
• Ensure the eTMF is being maintained up-to-date and all essential documents areappropriately filed in the eTMF
• Collaborates with CROs to ensure accurate data collection and entry into the CTMS andEDC
• Attend and contribute to team meetings taking detailed meeting minutes
• Supports clinical study management as delegated by Clinical Operations managers including liaison with external vendors
• Actively participates in process improvement initiatives to enhance clinical operations efficiency
• All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

• Bachelors degree in biological sciences health sciences or medical field or equivalent combination of education and experience required 4 years of experience in clinical study environment within CRO or Pharmaceutical company
• Experience using Clinical Trial Management Systems (CTMS) and Clinical Trial Master File Systems (eTMF) required Strong understanding of the phases of clinical drug development and clinical operation processes from start-up to close-out
• Knowledge of applicable FDA Code of Federal Regulations Good Clinical Practices and ICH guidelines
• Ability to organize prioritize tasks identify and resolve issues efficiently. Manage multiple tasks effectively and follow through on assigned tasks.
• Ability to receive general instructions on new assignments and perform routine work independently. Collaborate and work effectively within a team and within a multi-disciplinary environment.
• Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form
• Attention to detail accuracy and confidentiality

This is the pay for this position

Pay Transparency

$117000 - $137000 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 Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics 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.

Required Experience:

Senior IC