Clinical Data Manager ( multiple positions)

NEURO/GENERAL MEDICINE 

The Clinical Data Manager of Data Management at is a DM Generalist; will need to have a grasp on all aspects of DM from study start up, interpretation of study protocols, CRF design, UAT study conduct tasks, managing of off shore DMs and all processes related to DM lock. This individual will need to be able to work on multiple projects, and ensure aggressive timelines are met.

The Data Management group requires an operational Clinical Data Manager DM due to an increased number of new studies (15 or more) We are requesting a new hire (Contractor) in order to minimize the impact to the programs, study start-up and DM lock timelines. 

The CDM will be responsible for oversight and training DMs in managing data queries and in performing vendor data reconciliation. 

The PDM will review output as related to Vendor reconciliation and make decisions as to what discrepancies need follow up by Vendors and clinical trial sites. 

Additionally, he/she will ensure that all safety data between the project DB and Safety DB is reconciled and corrected as appropriate. 

They will need to utilize review to program, and review output as related to data cleaning.

The successful candidate must have the following skills:

• 3-5 years’ of experience in overseeing DB setup, leading UAT, meeting aggressive timelines and ensuring the accuracy of essential DM documents.

• Proven experience in meeting challenging timelines and KPIs.

• Experience in managing vendors and problem solving issues regarding data capture and data errors found in data transferred from Vendors.

• Experience in mentoring and managing the work of less experienced DMs.

• Building successful relationships with cross-functional team members.

• Accountability for quality of data performed and DB build activities by off shore team.

• Bachelor’s/Master’s Degree in Computer Science, or Life Sciences is required.

Manisha Jathar

732 429 1850