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Senior Project Clinical Data Manager

4 months ago

London UK, UK, United Kingdom Empatico Consulting Full time

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 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
  • Participate in and present at internal, customer, third-party, and investigator meetings or seminars
  • Development of departmental strategies, technologies, SOPs and process
  • 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

Duties include:

  • 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)
  • Provide support with the definition, identification and minimisation/prevention of Protocol Deviations and the associated process
  • Schedule and request data transfers/imports/exports to/from eCRF/eSource database and associated databases
  • Creation, Peer review and approval of:
  • 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
  • Participate and present at internal, customer, third-party, and investigator meetings

· Oversee preparation and attend sponsor/regulatory audits as required

  • Actively identifies and participates in the development of departmental technologies, SOPs, processes, and procedures
  • Contribute to the Request for Proposal (RFP) and Request for Information (RFI) process. Prepare input and participate in bid defence meetings

Essential

  • Degree or equivalent
  • 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
  • Detailed knowledge of CDISC with experience mapping and programming SDTM standard datasets
  • 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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