We are seeking a Sr/Manager, Clinical Data Management to oversee clinical data management activities across multiple studies from study start-up through study closure in support of clinical trial objectives and corporate goals. This role will not be boring! Success will lead to numerous publications, successful FDA interactions, and career growth opportunities. The experienced applicant may work remotely with availability for onsite team meetings as necessary. On-the-job learning and a desire to say ‘yes’ to new things are expected. The candidate will be part of the Clinical Affairs team and report into the Chief Medical Officer.
• Work closely with clinical operations, biostatisticians, and other cross-functional team members to develop study documents (protocols, SAP, Tables, Listings and Figure shells).
• Complete all data management deliverables on time and in accordance with quality standards and requirements throughout study lifecycle.
• Manage and oversee Data Management vendors or CRO partners
• Develop eCRF specifications, completion guidelines, annotated Case Report Form (CRF), data validation specifications, data transfer agreements, and data management plans.
• Perform User Acceptance Testing, including the creation of UAT plans & test scripts
• Perform quality control checks, data reviews on study data and address data queries.
• Assist the clinical study team with tracking & reporting data trends and metrics.
• Act as subject matter expert for data management issues between external domestic and international research sites for assigned studies
• Assist in the development of departmental standards, operational procedures, and best practices.
• Bachelor of Science degree in a scientific discipline or equivalent college program
• At least 8 years of clinical data management experience
• Experience with EDC systems, with a strong preference using Medrio
• Experience running clinical trials outsourced to a CRO as well as managed in-house
KNOWLEDGE, SKILLS, AND ABILITIES:
• Excellent verbal and written communication
• Knowledgeable in GCP, CDISC standards, clinical trial guidelines & Data Management Best Practices
• Excited to ‘wear many hats’, and self-motivated to take on new challenges
• Track record of success in a deadline-driven and multi-task environment
• Well organized and detailed oriented
SALARY AND CLASSIFICATION:
• Compensation: Competitive and commensurate with experience; includes equity package.
HOW TO APPLY: Please forward a cover letter and resume to jobs [at] inflammatix.com