Manage and evolve WeTravel's Help Center with clear product documentation. Collaborate cross - functionally to enhance user experience and support.
About the role
- Manager of Clinical Data Management overseeing clinical data integrity and quality in oncology trials at Summit Therapeutics. Leading data management activities and collaborating with cross-functional teams for successful project execution.
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.
Requirements
- Bachelor's 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.
Benefits
- bonus
- stock
- benefits and/or other applicable variable compensation
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Leiter/ Verantwortlicher Getränke - markt in HIT Handelsgruppe mit über 100 Märkten in Deutschland. Präsentation von Waren und Verantwortung für Getränke - Inspiration und Einkaufserlebnis.
Team Leader for fresh food counters at HIT grocery stores in Munich. Responsible for managing availability and display of fresh food products, leading a motivated team.
Store Manager responsible for managing the Hamburg store and developing the team through training and guidance. Engaging in merchandising and active selling while planning shop activities.
Leiter/Verantwortlicher für Frische - und Bedientheke bei HIT Handelsgruppe in Deutschland. Verantwortlich für Frischethekenmanagement und Kundenservice in einem innovativen Lebensmittelunternehmen.
Project manager specializing in contract and claim management for construction projects in Berlin. Involves negotiations, risk analyses, and teamwork with technical project leads.
Store Manager Assistant responsible for shop operations and creating a great customer experience. Coordinating daily business and assisting the Shop Manager in a dynamic retail environment.
Supporting the Store Manager as a Store Manager Assistant in a fashion retail store. Responsible for store operations and enhancing customer experience while coordinating with the team.
Store Manager Assistant managing all shop operations and creating a great shopping experience in Radolfzell. Coordinating daily business and assisting the Shop Manager while inspiring the team.
Store Manager leading retail operations at ONLY in Friedrichshafen. Overseeing team development, merchandising, and shop activities with a focus on fashion trends and performance.