Lead Clinical Data Manager - Remote
About the Role
Our client, a leading global pharmaceutical innovator, is seeking a highly experienced and motivated Lead Clinical Data Manager to join their expanding, remote-first team. This pivotal role will oversee the management and integrity of clinical trial data, ensuring compliance with regulatory standards and supporting critical drug development decisions. Based entirely remotely, you will lead a team of data managers, driving best practices in data collection, validation, and database lock processes across multiple clinical studies. This is an exceptional opportunity to shape data management strategies for cutting-edge pharmaceutical research from the comfort of your own home. You will play a key role in ensuring the accuracy and reliability of data that underpins life-saving therapies. The position requires a strong understanding of data management principles, CDISC standards, and regulatory guidelines.
Key Responsibilities
Lead and mentor a team of clinical data managers, providing guidance and oversight. Develop and implement data management plans (DMPs) for clinical trials, ensuring adherence to protocols and regulatory requirements. Oversee the design, build, and testing of clinical databases (e.g., EDC systems). Manage data cleaning activities, including query generation and resolution, to ensure data accuracy and completeness. Ensure compliance with all relevant regulatory guidelines (e.g., FDA, EMA) and ICH GCP. Collaborate closely with biostatisticians, clinical operations, and programming teams to ensure seamless data flow and integrity. Perform User Acceptance Testing (UAT) for clinical databases and associated systems. Contribute to the development and maintenance of standard operating procedures (SOPs) for data management. Represent the data management function in cross-functional study team meetings.
Requirements
Bachelor's or Master's degree in a relevant scientific or technical field. Minimum of 8 years of experience in clinical data management within the pharmaceutical or biotech industry. Proven experience in leading data management activities and mentoring teams. In-depth knowledge of Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle InForm). Strong understanding of CDISC standards (SDTM, ADaM). Familiarity with Good Clinical Practice (GCP) guidelines and regulatory requirements. Excellent analytical, problem-solving, and organizational skills. Exceptional communication and interpersonal skills, with the ability to collaborate effectively in a remote environment. Proficiency in database query and data reconciliation processes. Experience with data visualization tools is a plus.
Benefits
As a fully remote position, our client offers unparalleled flexibility and work-life balance. We provide a highly competitive salary, comprehensive health, dental, and vision insurance, and a robust 401(k) plan with generous company match. You will receive a generous allotment of paid time off, including vacation, personal days, and paid holidays. Our client is committed to professional development, offering opportunities for training, certifications, and conference attendance. We foster a culture of innovation and collaboration, supporting employees in their career growth. This role is a remote position, open to candidates across the United States.