FULL TIME LEAD CLINICAL DATA MANAGER
JOB DESCRIPTION: * Participate in and support RFP process (review RFP documents, pricing, attend bid defense) * Independently bring solutions to the CDM team/CDM department * Lead and/or participate in a focus team or global or local best practice team * Communicate lessons learned and/or present in CDM workshop(s) * Participate in the development and implementation of new technology or tool * Present at professional conferences and/or publish articles in professional journals * Provide review and input on developing, revising, and maintaining core operating procedures and work instructions * Perform other duties as directed by the functional manager
Required Knowledge, Skills and Abilities: * Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology * Knowledge of operating procedures and work instructions and the ability to apply them in practice * Knowledge of GCP and relevant regulatory guidelines * Excellent communication, interpersonal, customer service, and teamwork skills * Excellent project management skills * Excellent organizational and analytical skills * Comprehensive understanding of clinical drug development process * Demonstrated extensive data management skills and thorough knowledge of the data management process (e.g., therapeutic area, deep understanding in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology)
Required Education and Experience: * Bachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related discipline, and 5 years direct Data Management experience, including 3 or more years as a CDM project lead; or equivalent combination of education, training and experience * Previous experience and shown competence in leading delivery of multiple projects through full DM life-cycle (several studies/programs) * Previous experience of handling customer negotiations * Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology * Knowledge of operating procedures and work instructions and the ability to apply them in practice * Knowledge of GCP and relevant regulatory guidelines * Excellent communication, interpersonal, customer service, and teamwork skills * Excellent project management skills * Excellent organizational and analytical skills * Comprehensive understanding of clinical drug development process * Occasional travel is required
