Remote Clinical Data Manager - Global Pharmaceutical Trials
Our client, a global leader in pharmaceutical innovation, is actively seeking a meticulous and experienced Remote Clinical Data Manager to join their expanding team. This fully remote position will play a critical role in ensuring the integrity, accuracy, and quality of clinical trial data across various therapeutic areas. You will be responsible for the end-to-end management of clinical databases, from database design and setup to data validation, cleaning, and database lock. This includes developing and implementing data management plans, creating data validation checks, resolving data queries, and ensuring compliance with regulatory standards such as ICH GCP and FDA guidelines.
Key responsibilities include collaborating with clinical research associates, biostatisticians, and clinical scientists to define data collection requirements and database specifications. You will also be involved in the generation of data management reports, the reconciliation of clinical data with other databases, and the validation of electronic data capture (EDC) systems. This role demands a strong understanding of clinical trial processes, a keen eye for detail, and proficiency in various data management software and EDC platforms. Excellent communication skills are essential, as you will be interacting with diverse teams across different time zones.
The ideal candidate will possess a Bachelor's or Master's degree in a relevant field such as life sciences, computer science, or statistics, coupled with at least 4-6 years of direct experience in clinical data management within the pharmaceutical or biotech industry. Proven experience with EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva) is mandatory. A solid understanding of CDISC standards (SDTM, ADaM) is highly desirable. You should be adept at managing multiple projects simultaneously, prioritizing tasks effectively, and working independently with minimal supervision in a remote setting. A commitment to data quality and patient safety is paramount. This is an exceptional opportunity to contribute to life-changing therapies from the comfort of your home office, with the full support of a leading pharmaceutical organization.
Key responsibilities include collaborating with clinical research associates, biostatisticians, and clinical scientists to define data collection requirements and database specifications. You will also be involved in the generation of data management reports, the reconciliation of clinical data with other databases, and the validation of electronic data capture (EDC) systems. This role demands a strong understanding of clinical trial processes, a keen eye for detail, and proficiency in various data management software and EDC platforms. Excellent communication skills are essential, as you will be interacting with diverse teams across different time zones.
The ideal candidate will possess a Bachelor's or Master's degree in a relevant field such as life sciences, computer science, or statistics, coupled with at least 4-6 years of direct experience in clinical data management within the pharmaceutical or biotech industry. Proven experience with EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva) is mandatory. A solid understanding of CDISC standards (SDTM, ADaM) is highly desirable. You should be adept at managing multiple projects simultaneously, prioritizing tasks effectively, and working independently with minimal supervision in a remote setting. A commitment to data quality and patient safety is paramount. This is an exceptional opportunity to contribute to life-changing therapies from the comfort of your home office, with the full support of a leading pharmaceutical organization.