Clinical Data Team Lead - FSP

Job Description

Summarized Purpose: Acts as the lead data manager for one or more projects or to provide support to the lead data manager. May lead all data management activities for individual, limited volume/complexity studies with support from senior team members. Acts as an interdepartmental and client liaison for all DM study activities

The key skill sets would be SDTM proficiency (SDTM requirements listed below) along with good project management and communication skills. The person needs to be independent and demonstrate good leadership skills. This would be a good opportunity for anyone who wants to explore FSP and also work in collaboration with the client and other CROs and stakeholders.

• SDTM proficiency and how much they have used it on a day to day basis.

• Awareness of CDISC Standards and SDTM Structure

• Review of SDTM Test package, SDTM Specifications

• Review define.xml files and identify error messages

• Run and review Pinnacle 21 reports.

• Creation of the Data Transfer Agreement with respect to SDTM standards.

Knowledge, Skills and Abilities:  Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations Ability to use interactive computer programs  Good written/ verbal communication skills with a strong command of English language and grammar; good organizational, analytical/problem solving skills and attention to detail  Ability to work productively with minimal supervision  Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data  Strong customer focus and excellent interpersonal skills  Proven flexibility and adaptability  Ability to work in a team environment and independently as needed  Ability to train and direct study team  Ability to set and meet timelines or be able to recognize and schedule changes in response to project