Overview
Senior Project Clinical Data Manager Jobs in London – England – UK at Empatico Consulting
Title: Senior Project Clinical Data Manager
Company: Empatico Consulting
Location: London – England – UK
Category: IT/Tech, Management
Senior Project Clinical Data Manager We have the pleasure of working with a fantastic early phase CRO based in London. The company have a strong
leadership
team who are accelerating growth and have a great vision for the future. The offices are very
modern
and they have a fully kitted out clinical site close by. They take an encouraging attitude towards management,
autonomy
, work/life balance, inclusivity and have a great culture.
They are very team orientated, projects are
collaborative
and it really is a very positive place to work Due to their growth, they are now looking for a Senior Project Clinical Data Manager to join their Data Management team.
You will
act as the primary Data Management Lead for assigned projects, take responsibility for resourcing and planning and carry out
leadership
and management of projects and clinical trial data from design of the study through to final delivery of clinical datasets. Providing SAS programming support through all phases of the projects along with detailed knowledge of CDISC with experience of mapping and programming SDTM standard datasets is essential.
This is a hybrid role and will initially require more office presence, gradually transitioning to a flexible schedule, possibly one day per week. Role Overview:
Provide
leadership
and where required, management of Project Data Managers and other staff, in addition to
leadership
and management of projects and clinical trial data from design of the study through to final delivery of clinical datasets. Act as the primary Data Management Lead for assigned projects ensuring clinical projects are carried out by the company in accordance with the executed contract, ICH GCP and other relevant regulations and guidelines and the customer’s expectations, taking responsibility for resourcing and planning of assigned projects.
Provide hands on technical data management expertise and SAS programming support through all phases of the projects following industry standards (CDISC), from database build through to delivery of mapped datasets. Support projects from both the Clinical Site data perspective, as well as the Data Management vendor side. Key areas of responsibility Functional Lead for Site Source Data Management or Vendor Data Management on assigned projects Delivery and completion of all data management according to contractual agreement, relevant SOPs, guidelines and regulations Responsible for scope, budget, revenue
recognitions
for data management aspects of projects and provide support to junior staff on their projects
Resource management
for assigned projects Creation, review and approval of all Data Management associated documentation eCRF/eSource database and Edit checks design, build and validation Programming of off-line validations and database mapping using SAS Query management, Coding, SAE and third party data reconciliation Responsible for driving the oversight and management of the database lock process in accordance with the study plans, including data review meeting preparation and participation, data review report writing/validation, and Data Management Report writing Primary point of contact for specified external data vendors Oversee the setup/design of study specific paper source and/or e-Source database and associated documentation Provide project/system specific training for CRAs and site staff as required Manage…
