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Senior Project Clinical Data Manager

4 months ago

London, 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 projectsnDelivery and completion of all data management according to contractual agreement, relevant SOPs, guidelines and regulationsnResponsible for scope, budget, revenue recognitions for data management aspects of projects and provide support to junior staff on their projectsnResource management for assigned projectsnCreation, review and approval of all Data Management associated documentationneCRF/eSource database and Edit checks design, build and validationnProgramming of off-line validations and database mapping using SASnQuery management, Coding, SAE and third party data reconciliationnResponsible 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 writingnPrimary point of contact for specified external data vendorsnOversee the setup/design of study specific paper source and/or e-Source database and associated documentationnProvide project/system specific training for CRAs and site staff as requirednManage and oversee Quality Control (QC) process checks for eCRF database versus paper source / e-sourcenManage and oversee scheduled data transfers/imports/exports to/from eSource/eCRF database and associated systemsnParticipate in and present at internal, customer, third-party, and investigator meetings or seminarsnDevelopment of departmental strategies, technologies, SOPs and processnDevelop and delivery of applicable data management trainingnSupport departmental management by training, developing and mentoring of data management staffnMaintain proficiency in Data Management systems and processesnNetwork with colleagues for new and/or repeat businessnSupport departmental management by driving the development of Data Management tracking systems, databases and reporting systems to support business requirementsnDevelop and report on Data Management key performance indicatorsnContribute to the maintenance of data capture standards library

Duties include:

Liaise with Project Management and other functional groupsnOversee and manage all Data Management processesnProvide regular monitoring and communication of project progressnParticipate in project reviews and lessons learned by providing and presenting input from the data management areanMonitor data workflow using enrolment, data collection/cleaning metricsnEnsure documents and databases (data sets) are archived and/or returned to the customer appropriately at the end of each studynCoordinate, 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)nProvide support with the definition, identification and minimisation/prevention of Protocol Deviations and the associated processnSchedule and request data transfers/imports/exports to/from eCRF/eSource database and associated databasesnCreation, Peer review and approval of:nproject 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;nspecifications for listings and summaries from eSource/eCRF databases, and external data sourcesnoutput from listings and summaries from e-Source/eCRF databases, and external data sourcesnParticipate and present at internal, customer, third-party, and investigator meetingsn· Oversee preparation and attend sponsor/regulatory audits as requirednActively identifies and participates in the development of departmental technologies, SOPs, processes, and proceduresnContribute to the Request for Proposal (RFP) and Request for Information (RFI) process. Prepare input and participate in bid defence meetings

Essential

Degree or equivalentnKnowledge of current regulatory regulations, GCP, ICH guidelines and Data-management industry standardsnSAS programmingnDetailed experience of end to end Clinical trial and Project Data Management processes, as well as extensive experience in the Data Management industrynDetailed knowledge of CDISC with experience mapping and programming SDTM standard datasetsnFlexible 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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