Responsible for managing the day to day collection and review activities for assigned projects, as well as providing programming support for the company’s clinical development programs, including developing and supporting EDC system.
Responsible for assisting clinical data management staff in the performance of their duties and assisting with administrative tasks related to the conduct and implementation of clinical trial data collection and data review activities for assigned projects. May also provide support of set up, validation, and reporting of clinical systems (i.e. Electronic Data Capture / EDC systems).
A DAY IN THE LIFE
· Develop project specific Data Management Plans (DMP)
· Design data reports as necessary to facilitate data review activities
· Perform data review/cleaning activities as outlined in the DMP
· Document progress of data collection, review and all other required activities to ensure completeness of data at project completion
· Formatting clinical case report forms to be consistent with the company’s licensed EDC system
· Development and validation of data structures, screen design and edit check specifications for EDC systems
· Resolve user and/or design issues in the EDC system
· Training and support of all users of the EDC system
· Assist in the development of data management Standard Operating Procedures (SOPs), Work Instructions and Forms.
· Supports other Clinical Data Manager(s) and other team members with ongoing conduct of clinical studies
· Assists the data management team in the preparation, handling, distribution, filing, and archiving of study documentation and reports according to the scope of work and standard operating procedures
· Assists with periodic review of study, department, and systems files for accuracy and completeness
· Assists with preparation of clinical systems validation materials
· Assists with preparation of clinical data capture training materials
· Develop and ensure timely delivery of clinical data reports to project team
· May contact clinical sites or coordinate with clinical team contact sites to facilitate query resolution, missing data, case report form (CRF) signatures, or other needs
· Assists with maintenance of study and department tracking tools
· Attends Proxima company meetings, completes timesheets and documents training
· Professionally represents Proxima in business interactions
KNOWLEDGE AND SKILLS
· Well organized with good time management skills.
· Proficient in the use of Microsoft Office.
· Strong attention to detail and accuracy in work.
· Strong problem solving and interpersonal skills.
· Good oral and written communication skills.
· Ability to articulate issues.
· Self-management skills, including the ability to multi-task.
· Ability to maintain confidentiality
EDUCATION & EXPERIENCE
· Minimum 4-year degree, preferably in a scientific, healthcare, or data management field. At least some familiarity with case report form design and development, DMP development, clinical study data review, and Java programming.
· Minimum of 4 years experience in clinical data management.
· Basic knowledge of clinical trial processes and ICH/GCP guidelines.
· Familiarity with common medical terminology.