Lead Clinical Data Manager - Charlotte
22 hours ago

Job description
Responsibilities
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards.
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 7+ 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.
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)
Similar jobs
Data Manager role involves designing developing maintaining data pipelines infrastructure for data storage processing analysis extracting transforming loading ETL data from various sources into appropriate data storage systems. ...
1 month ago
This job is responsible for driving accurate complete timely delivery of data Key responsibilities include working with business stakeholders technology teams to direct data management activities ensure availability use by appropriate consumers Job expectations include managing e ...
2 weeks ago
We are looking for a highly experienced Senior Data Engineer to design, build, · and optimize enterprise-scale data pipelines and analytics platforms. · Design, develop, and maintain end-to-end data pipelines (ETL/ELT) · Integrate data from multiple sources (databases, APIs, clou ...
1 month ago
We are reimagining how people live, work, play and connect by providing fast, reliable internet connections and an awesome customer experience in twenty states throughout the Midwest and South. · The Manager, Data Quality & Reliability leads the technical execution and operationa ...
1 week ago
We want to help you grow develop and learn new things. You're constantly evolving so shouldn't your opportunities be too? · We are looking for a dynamic leader with excellent communication skills and experience leading a high potential team with a background in technology busines ...
1 month ago
The role is responsible for driving accurate, complete, and timely delivery of data. Key responsibilities include working with business stakeholders and technology teams to direct data management activities and ensure availability for use by appropriate consumers. · ...
4 days ago
We are reimagining how people live, work, play and connect by providing fast, reliable internet connections and an awesome customer experience in twenty states throughout the Midwest and South. · ...
1 week ago
Job Description: · At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. We do this by driving Responsible Growth and delivering for our clients, teammates, communities and shareholders every day. · Being ...
1 day ago
We are guided by a common purpose to help make financial lives better through the power of every connection. We do this by driving Responsible Growth and delivering for our clients, teammates, communities and shareholders every day. · ...
1 week ago
As the Data and Compliance Manager, this pivotal leadership role marks the transition from managing individual compliance projects to overseeing a broader portfolio of work in the independence compliance department of the Forvis Mazars network. · ...
1 month ago
In this contingent assignment, you will provide expert consultation on large-scale, complex Data Management initiatives. You will analyze multidimensional data challenges, evaluate cross-functional impacts and help drive high-quality solutions that meet compliance regulatory and ...
4 days ago
We are seeking a highly skilled data professional to support complex large-scale Data Management initiatives.In this contingent role you will partner with cross-functional teams to assess multifaceted data challenges drive analytical insights and contribute to strategic planning ...
1 month ago
We are seeking a highly motivated Data Product Manager to join our Data & Analytics team.This role is critical in leading the development, evolution and success of our data solutions... · ...
2 weeks ago
We invite passionate individuals to join our team, dedicated to exceeding customer expectations through innovative and sustainable solutions. · The Manager, Data Support and Operations leads a team responsible for maintaining, supporting, and optimizing Xylem's enterprise data sy ...
1 month ago
We are seeking an experienced Manager of Data Operations to join our talented Information Technology team. The position offers growth, flexibility and a collaborative work environment. · In this position you should have the following; excellent interpersonal skills with the abili ...
4 weeks ago
We are seeking a Data Product Manager to connect business product owners with technology delivery teams using data to power experiences for our advisors and investors. · The ideal candidate will have proven ability to construct and direct technology projects in line with organiza ...
1 month ago
The Product Manager will bridge product strategy with data-informed decision-making, · identifying problems our platform needs to solve and partnering with technology teams to build effective solutions. · This role leverages data to drive product decisions and measure outcomes—an ...
1 month ago
The Data Management Specialist is responsible for high-volume data entry and quality control of land rights and related documentation. · ...
3 weeks ago
We are looking for an experienced Data Engineering Manager to lead and grow a high-performing team responsible for designing building and maintaining scalable data platforms pipelines. This role blends technical leadership people management strategic thinking to ensure data is re ...
1 week ago
The Data Strategy Lead/Data Product Manager is accountable for defining and driving the strategic direction of a specific data domain or capability within banking domain. · ...
5 days ago
We need people like you who are ready to merge your talents with your passion to make a difference. Apply today and discover the power of mentorship and the impact of your work behind the scenes. · Serve as primary administrator of the organization's CRM, ensuring data accuracy, ...
1 month ago