Covance Clin Data Mgr II in Maidenhead, United Kingdom

Job Overview

Covance is seeking a Lead Project data Manager to work sponsor dedicated. Home based role in the UK, permanent contract.

JOB RESPONSIBILITIES

  • Define and direct the data management workflow for assigned projects in collaboration with client manager ensuring all necessary data quality control and integrity measures are in place

  • Work with client manager on the prioritization of projects and establish plans for meeting timelines agreed with Study management Teams

  • Serve as the data management SME on multidisciplinary project teams providing specific expertise on timeline development, identification of data management deliverables and resource requirements

  • Participate in the creation, review, and maintenance of project timelines and monitor progress of data management activities

  • Assist in the preparation and review of specifications for designing, monitoring and transferring of databases

  • Assist in the development and implementation of the design and programming of clinical databases

  • Perform user acceptance testing on database applications and data transfers

  • Create, review, approve and maintain edit specifications, CRF design, CRF Completion Guidelines, data cleaning procedures, data management plans and other data management supportive tools with study team members according to protocol specific requirements and available guidance documents

  • Review, analyze and validate clinical trial data throughout the study lifecycle to ensure data consistency, completeness, integrity and accuracy based on project specific guidelines

  • Query data inconsistencies and revise CRFs when necessary to comply with company and/or regulatory guidance and standard operating procedures

  • Generate and review reports and listings as required to maintain data integrity and reporting

  • Communicate study status, timeline updates, scope changes with internal Study Team members and departmental leadership

  • Lead the data cleaning process, track and resolve queries for the study lifecycle, close out and database lock procedures in collaboration with the Lead Team Members

  • Manage and/or liaise with third party vendors specifically related to data collection, analysis and project timelines

  • Develop strong working relationships and maintain effective communication with study team members

  • Assist in developing data management process and procedure improvements and standard operating procedures

  • Generate data retrievals and summaries

REQUIREMENTS

  • Bachelor’s degree

  • Expertise in EDC and Medidata Rave, preferred

  • Extensive clinical data management experience

  • 4+ years experience in data management

  • Comprehension of medical terminology desirable

  • Proficient experience using commercial clinical data management systems and/or EDC products

  • Experience using relational databases

  • Strong interpersonal skills, demonstrated capability of working on multiple projects simultaneously

  • Ability to complete deliverables on time and adjust priorities in a fast paced environment

  • Ability to work independently as well as a collaboratively in a team environment accepting accountability

  • Excellent verbal and written communication skills

Education / Qualifications

  • Bachelor’s degree

  • Expertise in EDC and Medidata Rave, preferred

  • Extensive clinical data management experience

  • 4+ years experience in data management

  • Comprehension of medical terminology desirable

  • Proficient experience using commercial clinical data management systems and/or EDC products

  • Experience using relational databases

  • Strong interpersonal skills, demonstrated capability of working on multiple projects simultaneously

  • Ability to complete deliverables on time and adjust priorities in a fast paced environment

  • Ability to work independently as well as a collaboratively in a team environment accepting accountability

  • Excellent verbal and written communication skills

Experience

  • Bachelor’s degree

  • Expertise in EDC and Medidata Rave, preferred

  • Extensive clinical data management experience

  • 4+ years experience in data management

  • Comprehension of medical terminology desirable

  • Proficient experience using commercial clinical data management systems and/or EDC products

  • Experience using relational databases

  • Strong interpersonal skills, demonstrated capability of working on multiple projects simultaneously

  • Ability to complete deliverables on time and adjust priorities in a fast paced environment

  • Ability to work independently as well as a collaboratively in a team environment accepting accountability

  • Excellent verbal and written communication skills

Job Number 2018-26621

Job Category Clinical Data Management

Position Type Full-Time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.