Employment Opportunities:

Clinical Data Manager - Bannockburn, Illinois

The Clinical Data Manager will successfully coordinate all data management activities including all aspects of study setup, conduct and closeout of assigned studies.  Participate in development of the paper CRF or the eCRF and validation in coordination with the Clinical Operations team and programmers. Carefully plans and coordinates with Clinical Operations Team responsible for monitoring clinical studies to support and facilitate effective and timely query resolution.  Works closely with Safety team for coding medical terms and reconciling the serious adverse events. Provide data listing reports and transfers to facilitate the data cleaning process to ensure a clean database lock per the study timelines.  Proactively lead closeout/lock activity of the database by working with internal and external teams to ensure a smooth and successful operation. The Data Manager is also expected to have a strong risk management skill set and discuss issues in team meetings and to her/his manager in a timely fashion

KNOWLEDGE SKILLS AND ABILITIES:

• Exceptional communicator, time management, planning and organization skills
• General programming/logic knowledge to design effective edit checks
• Basic knowledge of reading and interpreting the protocol and converting it to a suitable and comprehensive CRF
• Ability to participate in database development and validation
• Ability to work productively and independently
• Excellent logical and analytical abilities
• Ability to provide regular project status update at team meetings
• Proven ability to perform multiple tasks effectively in a stressful deadline-driven environment
• Proficiency in MS Office suite including
• Demonstrated ability to work with and motivate others
• Understanding 21-CFR Part 11 guidelines and CDISC guidelines
• Ability to be compliant with SOPs at all times
• Ability to assess work load and alert management of additional resources needed to deliver quality and timely database
• Ability to train and mentor data management staff as needed
• Perform other Data Management related duties as directed by management

EDUCATION AND EXPERIENCE

• Bachelor's degree in Biology, Pharmacology, Computer Science, Mathematics, Statistics or related field or an equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities to perform the above described responsibilities.
• Three to five years data management experience
• Experience with oracle-based systems, EDC studies and developing Data Management Plan

To apply for this opportunity, please submit your resume in confidence to hr@cytochroma.com. Please ensure that you quote the job title in the subject line of your email.

We thank all applicants for their interest; however, only candidates under consideration will be contacted. No phone calls please.