About the Role
Our client, a rapidly expanding global Contract Research Organization (CRO) specializing in clinical trial management, is looking for a highly motivated and experienced Senior Clinical Data Manager to join their fully remote team. This is an exceptional opportunity to contribute to groundbreaking clinical research projects from the comfort of your own home office. You will be responsible for overseeing the quality, integrity, and timeliness of clinical trial data, ensuring compliance with regulatory standards and protocol requirements. This remote-first position offers the flexibility and autonomy to manage your workload effectively while collaborating with international project teams and clients. This role is ideal for a seasoned professional seeking a challenging and rewarding career in a remote setting.
Key Responsibilities
- Oversee the end-to-end clinical data management process for assigned clinical trials, ensuring data quality and integrity.
- Develop and manage Data Management Plans (DMPs), including data collection, cleaning, validation, and database lock procedures.
- Design, develop, and validate Electronic Data Capture (EDC) systems and associated edit checks.
- Collaborate closely with Clinical Operations, Biostatistics, and Medical Writing teams to ensure accurate and timely data processing.
- Perform data review and quality checks, identifying and resolving data discrepancies in a timely manner.
- Manage external data integrations and reconciliation processes.
- Contribute to the development and maintenance of data management standards, SOPs, and best practices.
- Provide guidance and mentorship to junior data managers and data management staff.
- Ensure all data management activities are compliant with ICH-GCP, regulatory requirements, and client specific needs.
- Participate in client meetings and regulatory audits as the data management subject matter expert.
Requirements
- Bachelor's degree in a relevant scientific or technical field (e.g., Computer Science, Statistics, Life Sciences).
- Master's degree preferred.
- A minimum of 6 years of experience in clinical data management within the pharmaceutical or CRO industry.
- Proven experience managing clinical trial data using EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva EDC).
- Strong understanding of clinical trial processes, ICH-GCP guidelines, and data management best practices.
- Proficiency in database design, data validation techniques, and data querying.
- Excellent analytical, problem-solving, and organizational skills.
- Exceptional written and verbal communication skills, with the ability to communicate effectively with diverse stakeholders.
- Demonstrated ability to work independently and manage multiple projects simultaneously in a remote environment.
- Experience with programming languages (e.g., SQL, SAS) for data analysis and reporting is a plus.
- Must be legally authorized to work remotely in the designated region.
Benefits
- This remote position offers a competitive salary and a comprehensive benefits package designed for remote professionals.
- Benefits include excellent health, dental, and vision insurance, a retirement savings plan with company matching, and generous paid time off.
- Our client also provides a home office stipend, professional development allowances, and opportunities for advancement within a growing global organization.
- You'll have the autonomy to manage your work and contribute to life-changing clinical research from anywhere.
- Join our client's innovative remote team and shape the future of clinical data management.