Covance

Lead Project Data Manager sponsor dedicated - Home based UK

5 days left

Company
Covance
Salary
On Application
Posted
09 Jan 2019
Closes
31 Mar 2019
Ref
LPDM - UK

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

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