Senior Clinical Data Manager

Member of clinical research team responsible for data management activities across multiple trials. Activities include assisting in data entry, query processing, site management, data reporting and other data management activities in support of clinical trial projects.

ESSENTIAL FUNCTIONS:

Perform data management activities on both paper based and Electronic data capture (EDC) studies. Major activities include:

•CRF data review, preparation for entry, query processing, discrepancy management, adhoc reporting and listing generation.

•Develop study specific database requirements and edit check requirements with the help of Clinical Research Associates (CRA) and field monitors.

•Create and maintain data management trackers and checklists for multiple projects.

•Set-up and keep track of new sites, users across studies for EDC studies.

OTHER RESPONSIBILITIES INCLUDE:

•Assist in CRF design/development.

•Assist with database design and validation activities (for paper based trials).

•Support with EDC study validation, user acceptance testing and implementation.

•Assist in development of data verification audit listings and other audit activities.

•Design case report forms.

•Build database using ORACLE Clinical and Remote Data Capture.

•Assist in overall project tasks such as generating CRF completion guidelines, process flowcharts, Standard Operating Procedures (SOPs), work instructions and training guidelines.

•Support the team in any study startup and closeout activities including final report data QC.

DEPARTMENT SPECIFIC FUNCTIONS:

•Participate in project meetings to give a status update to project managers and upper management.

•Assist in preparation of study material for investigator, study coordinator and monitor meetings.

Requirements MINIMUM REQUIREMENTS:

Education required/ preferred: Bachelors degree in sciences or health profession.

Experience: Five to eight years industry experience; minimum 2 years experience in medical device and/or pharmaceutical data management environment.

Preferred Skills/Qualifications:

•Computer literacy in MS Word, Excel, PowerPoint, Access, ORACLE Clinical, RDC and CRF design tools.

•Ability to speak, write and understand English to comply with written procedures, instructions, SOPs and other documents.

Skills/Competencies:

•Excellent organizational skills and attention to detail.

•Ability to prioritize and multitask is a plus.

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

Will work primarily within Clinical Affairs but may have to interact with the Quality and Regulatory Affairs staff. Scope will include multiple clinical studies at a time.