Clinical Data Manager

Averion International has an opening in its world headquarters in Southborough MA. Averion is an international CRO specializing in oncology, cardiovascular and medical device trials.

The Clinical Data Manager (CDM) works under general supervision and is involved in all Data Management aspects of a clinical trial: assists with CRF design and review; writes CRF completion guidelines; provides validation check specifications; performs database and validation check testing; develops data management plan; designs and maintains study documentation; reviews data; generates queries; performs SAE reconciliation; represents Data Management within the global study team; liaises with clients provides progress reports; provides input into Data Management process improvement and may participate in training other CDMs.
ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING:

• Represent Data Management within the clinical study team and liaise with clients
• Provide support for CRF design and review to ensure CRF efficiency and consistency with study protocol
• Create CRF completion guidelines
• Present CRF, CRF completion guidelines and study related Data Management processes at Investigator / monitor meetings
• Perform database user acceptance testing
• Write / review validation check specifications
• Perform validation checks user acceptance testing
• Create and maintain the Data Management Plan (DMP), Data Handling Manual and other study specific procedures documentation
• Review automatic discrepancies, CRFs, data listings to identify missing or discrepant data, write clear and concise queries (DCFs)
• Integrate query answers into the clinical database
• Coordinate import/ exports of data with external data providers
• Reconcile clinical AEs with SAEs according to established guidelines
• Coordinate interim and final database audits according to database QC plan
• Monitor Clinical Data Management project status through use of standardized Data Management status reports and customized metrics, using PL/SQL, Clintrial Retrieve module or Crystal reports
• Assist with project planning and work to agreed timelines and budget
• Organize internal project team meetings and facilitate efficient project communication
• Coordinate / assist with database lock process and ensure that all steps prior to locking the database are complete
• Provide study specific training to other team members
• Act as DMS-TL for assigned projects / programs by ensuring DMS services are delivered according to agreed timelines with high quality and within budget
• Represent department at industry and client meetings
• Perform coding as needed
• This job description may include additional individual
duties and responsibilities not listed in detail but still expected to be reasonably performed.

QUALIFICATIONS / EXPERIENCE REQUIRED:
• Bachelors’ degree in a Life Science discipline or an equivalent combination of education and work experience plus a minimum of 1 year of clinical data management experience, or an equivalent combination of education and experience
• Experience with Clinical Data Management Systems. Knowledge of Clintrial version 4.6 or higher and basic programming skills (PL/SQL, SAS) preferred
• Excellent interpersonal, communication skills
• Detail-orientated
• Flexible and able to work in a team environment to meet timelines and achieve project deadlines
• Excellent organizational skills with the ability to prioritize and multitask
• Logical thinker with strong problem solving skills
• Ability to work independently
• Fluent in verbal and written English
• Good understanding of the fundamentals of ICH/GCP guidelines
• Basic understanding of clinical trials conduct process
• Infrequent occasional travel may be required

Please apply on our website www.averionintl.com