Position Summary: With our continued growth, we have an opportunity to join our world-class Data Management Team in a long-term contract role. The Contract Clinical Data Manager will be responsible for coordination and oversight of data management activities in support of the clinical trials/programs
Duties and Responsibilities:
- Clinical sub-team team leader: works closely with the Clinical Trial Manager and is responsible for oversight and execution of data management activities for assigned clinical studies including data timelines and key deliverables
- Preparing, validating and maintaining clinical trial databases according to ICH/GCP guidelines and current regulatory requirements.
- Leads in database development and eCRF design, UAT, data import specifications, Case Report Form completion guidelines, data entry guidelines and related operations manuals.
- Leads in database build and UAT
- Develops and executes data validation specifications and programs for assuring the accuracy of clinical trial data, e.g., data review guidelines, computerized edit check programs, Data Management Plans (DMP).
- Responsible for executing or overseeing data cleaning activities: includes generating and managing clinical trial data queries, coding specified clinical trial data, e.g. adverse events and concomitant medications, reconciling serious adverse events.
- Tracking and reporting data management project status.
- Assisting in data system development initiatives and database integration projects.
- Works directly with and oversees CROs and vendors for Data Management services.
- Participation in outsourcing/vendor selection for Data Management services and software.
- Tracks data status and timelines and feeds data into performance metrics reporting for assigned clinical projects.
- Provides input and participates in development of clinical study documents including protocol and monitoring plans.
- Supports CTM in coordination of receipt of all ancillary data e.g. safety lab data, analytic lab data, IVRS randomization data to ensure data is received at the time of database lock.
- Participate in SOP development, training, process mapping, and other departmental activities.
Education/Skills and Experience Requirements:
- Science background BS or healthcare degree
- Experience minimum 5+ years in a pharmaceutical/biotech, CRO setting, global/international experience a plus
- Expertise EDC and industry standards including ICH-GCP guidelines, and CDASH/CDISC
- Strong understanding of Basic, SAS, SQL and/or other clinical programming.
- Strong understanding of application of clinical data coding classification systems, e.g., MedDRA, WHO Drug.
- Strong interpersonal, organizational, and communication skills
- Excellent attention to detail and problem solving skills
- Ability to work effectively work in a team setting
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.