Job Title: Senior Manager, Clinical Data Management
Department: Clinical Data Management
Overview of Role:
Summit is seeking an experienced, detail-oriented Sr. 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 multiple 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.
- Lead the selection, oversight, and performance management of external data management vendors.
- Develop and 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.
Experience, Education and Specialized Knowledge and Skills:
- Bachelor’s degree in Life Sciences, Computer Science, or a related field; advanced degree preferred.
- 8+ years of clinical data management experience in the biotechnology or pharmaceutical industry, with at least 3 years in a leadership role.
- Extensive 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:
- 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 $145,000 to $160,000 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.
#J-18808-Ljbffr
