Manager, Clinical Data Management
Manager, Clinical Data Management
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$ 135000 - 155000
1 Vacancy
Job Description
Location: On-Site 4 days per week at our Menlo Park CA Princeton NJ or Miami FL office.
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:
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 $135000-$155000 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.
Required Experience:
Manager
Employment Type
Full-Time
