Manager, Clinical Data Management

Location: On-Site 4 days per week at our Menlo Park CA or Princeton NJ office.

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.

Overview of Role:

Summit is seeking an experienced detail-oriented Manager of Clinical Data Management with a strong background in oncology clinical trials. This role will lead and oversee clinical data management activities ensuring the integrity quality and timeliness of clinical data across multiple oncology studies.

Role and Responsibilities:

• Lead and manage clinical data management activities for oncology clinical trials ensuring adherence to project timelines budgets and quality standards.
• Provide strategic oversight and direction to CRO clinical data management teams for assigned studies.
• Develop and implement data management plans case report forms (CRFs) edit checks and data validation plans in alignment with study protocols and regulatory requirements.
• Oversee the design build and validation of clinical databases using Medidata Rave EDC ensuring optimal configuration and functionality.
• Conduct thorough reviews of clinical data identifying trends inconsistencies and potential issues that may impact data quality or study outcomes.
• Collaborate with cross-functional teams including Biostatistics Clinical Operations Safety and Regulatory to ensure alignment of data management strategies with overall clinical development goals.
• Provide oversight and performance management of external data management vendors.
• Maintain SOPs guidelines and best practices for clinical data management processes.
• Represent the Clinical Data Management function in internal and external meetings providing expert guidance on data-related matters.
• Stay current with industry trends regulatory requirements and technological advancements in clinical data management particularly in the oncology field.
• All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

• Bachelors degree in Life Sciences Computer Science or a related field; advanced degree preferred.
• A minimum of 5 years of clinical data management experience in the biotechnology or pharmaceutical industry.
• Experience managing oncology clinical trials data including a deep understanding of oncology-specific data requirements and challenges.
• Expert-level proficiency with Medidata Rave EDC including system configuration form design and edit check programming.
• Strong knowledge of clinical research processes FDA & ICH guidelines GCP GCDMP and CDISC standards.
• Demonstrated experience in CRO and vendor oversight.
• Excellent project management skills with the ability to manage multiple studies simultaneously.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Outstanding communication and interpersonal skills with the ability to effectively collaborate with diverse stakeholders.
• Proficiency in Microsoft Office Suite and familiarity with statistical software (e.g. SAS R) is a plus.
• Preferred Qualifications:
• CCDM (Certified Clinical Data Manager) certification
• Experience with risk-based monitoring in oncology studies
• Knowledge of emerging technologies in clinical data collection and management (e.g. ePRO wearables AI/ML applications)

The pay range for this role is $134500 - $158000 per year. 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.