Senior Clinical Data Manager

Veramed, UK - Remote +1

The role

An exciting opportunity to join Veramed's Data Management Business Unit! As we continue to grow and build on our success, we're looking to recruit a passionate and driven Senior Clinical Data Manager. You'll be required to have strong and in-depth experience of Data Management Study Start Up, Management of EDC Build, Medidata Rave (including eCOA) and experience of vendor management. Also This role can be based in our UK offices or a hybrid working model.

What you will do

The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.

Technical

Review of clinical protocols
Create or review Case Report Forms for data collection and compare with the protocol to ensure consistency
Create or review Edit Check Specification document
Preparation of UAT documentation and perform UAT of EDC and communication of findings
Creation of study specific documents such as Data Management Plan, Data Review Plan, eCRF Completion Guidelines, etc.
Create or review specifications for data review listings and / or customized reports to facilitate data cleaning
Ongoing review of data entered in EDC to ensure the data is clean for analysis
Issue queries to clinical monitors or investigational sites as appropriate
Resolve standard queries
Perform medical coding
Work with external vendors on data transfer agreements / specifications
Ensure external data is reconciled as required
Track queries and data cleaning activities to ensure ongoing review of data entered is completed and data is fit for analysis.
Maintain study master file documents and any other documents that are required to be audit ready
Work in accordance with internal (or sponsor, where applicable) SOPs and procedures

Project Management

May serve as the main contact for the sponsor
Awareness of study budget and proactive identification of scope changes
Ensure key project milestones are delivered on time with the highest quality
Maintain timelines and communicate risks / updates to the Data Management Project Manager
Collaborate with cross-functional team members to ensure that the study deliverables are provided on time and with quality

General

Lead internal and client study team meetings effectively
Present study updates internally and at sponsor meetings
Share scientific, technical and practical knowledge within the team and with colleagues
Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
Build effective collaborative working relationships with internal and sponsor team members
Seek opportunities to develop innovative ideas and sharing when appropriate
Mentorship of more junior team members
Contribution to development of internal training materials
Contribution to internal process improvement initiatives

Senior Clinical Data Manager

The role

Senior Clinical Data Manager

The role

What you will do

Technical

Project Management

General

What you need

Purpose

Similar jobs at other companies

Senior Clinical Data Manager

Senior Clinical Data Manager

Clinical Data Manager II

Clinical Database Programmer

Clinical Data Manager II

Lead Clinical Data Manager

Interview questions

Veramed