Principal, Data Manager - Consultant

Accountable for driving achievement of project milestones from study start up through to delivery of database

Provide Data Management input into the protocol

Design the Case Record Form and guide process for CRF approval

Define and develop the Data Management Plan, Data Validation Plan and their annexes (e.g. Reconciliation Plan), with input from the study team

Validation of the database and computerized checks, including SAS listings or SAS checks

For EDC studies, define the User Acceptance Test Plan (UAT) and execute the test activities in the test environment to ensure quality eCRF

For EDC studies, timely response to issues identified by the eCRF Helpdesk

Prepare CRF completion guidelines

Prepare study specific data-entry guidelines and train data-entry staff

Perform term coding for clinical studies, raise manual queries for uncoded terms as required

Query management: review discrepancies, review answered queries, resolve and close where appropriate, manage the data cleaning process including manual checks and Medical Review listings

Create and test import programs for electronic data received from external vendors

Perform timely data integration of CRF and non CRF data (data import from external sources)

Perform reconciliation of external data (e.g. SAE, Central Labs, ECGs etc)

Run and monitor study data progress reports including query management and take appropriate actions (e.g. escalation, re-training, etc), escalate any study issues within study team

Define and executive QC plan, lead and execute database release and database freeze activities

Lead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling and proritising

Input into and monitor progress against study project plan and escalate issues to resolution at the appropriate level

Proven ability to analyse data capture problems/opportunities and a track record of developing and delivering high quality solutions

Demonstrate broad and integrated knowledge of all aspects of Data Management providing consultancy to other groups outside CDM

Educate/train on use of study specific data collection tool(s) and query management process

Effectively contribute in formal training for new starters

Make recommendations for process improvements and development of new standards

Maintain continuous and appropriate communication with sponsors and share with them critical and general issues

Effective relationship management with vendors and customers in order to meet expectations and achieve results

Effectively represents Data Management in internal or external meetings (e.g. Investigator’s Meetings)

Conducts other activities as required

English, Good

MS Office Suite, Good

Professional

Trustworthy

Ability to effectively prioritize

Quality focused

Personable Attitude

Willingness to learn

Team Player

Effective Stress Management Techniques

Learning Agility

Ability to Manage Conflict

Problem Solving Skills

Effective Verbal Communication Skills

Commercial and Technical Writing Skills

Networking Skills

Analytical thinking

Resilient

Ability to Influence and motivate

Ability to manage difficult conversations

Innovative

Ability to Provide Constructive Feedback

Excellent Presentation Skills

Commercial awareness

Ability to recognize and develop talent