Senior Project Clinical Data Manager

1 month ago

London, United Kingdom Empatico Consulting Full time

Senior Project Clinical Data Manager
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.

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.

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 and oversee Quality Control (QC) process checks for eCRF database versus paper source / e-source
Manage and oversee scheduled data transfers/imports/exports to/from eSource/eCRF database and associated systems
Develop and delivery of applicable data management training
Support departmental management by training, developing and mentoring of data management staff
Maintain proficiency in Data Management systems and processes
Network with colleagues for new and/or repeat business
Support departmental management by driving the development of Data Management tracking systems, databases and reporting systems to support business requirements
Develop and report on Data Management key performance indicators
Contribute to the maintenance of data capture standards library

Liaise with Project Management and other functional groups
Oversee and manage all Data Management processes
Provide regular monitoring and communication of project progress
Participate in project reviews and lessons learned by providing and presenting input from the data management area
Monitor data workflow using enrolment, data collection/cleaning metrics
Ensure documents and databases (data sets) are archived and/or returned to the customer appropriately at the end of each study
Coordinate, define and implement user testing to a high standard for data entry screens, electronic edit checks, data listings, import/export programs and medical coding (e-source and eCRF systems)
Schedule and request data transfers/imports/exports to/from eCRF/eSource database and associated databases
project plans and guidelines for data validation, electronic data interchange, coding, paper source/e-Source, eCRF screen creation, database design, user testing, source and eCRF tracking and completion, and other applicable project plans as delegated/required;
specifications for listings and summaries from eSource/eCRF databases, and external data sources
output from listings and summaries from e-Source/eCRF databases, and external data sources
Oversee preparation and attend sponsor/regulatory audits as required
Knowledge of current regulatory regulations, GCP, ICH guidelines and Data-management industry standards
SAS programming
Detailed experience of end to end Clinical trial and Project Data Management processes, as well as extensive experience in the Data Management industry
Flexible and adaptive approach, being able to rapidly re-prioritise whilst maintaining a clear vision, as well as work effectively with various situations or individuals

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