Research Manager - Cambridge, Cambridgeshire, United Kingdom - Omnigen Biodata

Description

Study ManagerWe are looking for a Research Manager for our Discover Me platformrecruiting participants to a major research study that integrates health and genetic dataproviding all participants with access to their health and ancestry data.

Omnigen builds global biodata for discovery, real-world analytics, and precision medicine observational studies and clinical trials. As a Research Manager you will coordinate and oversee the operational activities related to the planning, execution and reporting of Omnigen studies including budgets, timelines, oversight of vendor performance, scope of works and budgets, ensuring compliance with study protocols, applicable laws and regulations (eg. ICH-GCP, the GDPR, where relevant), and with Omnigen standard operating procedures and associated documents. We have opportunities to work across various regions including the UK and South Africa.
This is a hybrid role with a minimum of two days in the Cambridge office.


Salary:
£40,000 – 50,000 per annum, dependent on qualifications and relevant experience

Responsibilities:

Oversee the execution and delivery of the study(s) in line with agreed company goals, processes and ethical and regulatory requirementsDevelop and execute the study protocol (and any amendments) and participant information sheet and consent form and ensure the study is conducted as per ethical and/or regulatory approvalsDevelop and maintain study timelines, including feasibility and recruitment projectionsOversee the development and ongoing identification and review of study level risk assessments including contingency planningDevelop and maintain the study budget including site and vendor/supplier budgetsDevelop the study management and monitoring plan and monitor the execution of studies against the study management and monitoring plan, risks, timelines, deliverables and budgetDevelop the Trial Master File (TMF) Plan and set up and maintain the TMF (including the investigator site file) as per the TMF plan including the oversight of quality and completeness reviews Communicate study status to senior management via status reportsOversee site management activities including site feasibility and selection, contracts and agreements, site set up and initiation, site monitoring, and close out activities.

Oversee vendor and supplier activities including relationship management and tracking of logistical aspects of the studyIdentify and resolve trends in participant queriesContribute to the continuous improvement of study planning and execution and implement innovative process ideas Qualifications, skills and experience:

The Study Manager will have the minimum qualifications of either: Minimum qualification of a bachelor's degree (BSc, BA or RN equivalent) in a biological or science-related field; or Equivalent experience or qualifications in a relevant field Other essential requirements:Demonstrated experience of managing epidemiological field studies or clinical research studiesProficiencies in MS Office Suite experience – Word, Excel, PowerPoint, ExcelExcellent communication skills and ability to deal with difficult or pressured situations and to work on a number of projects simultaneouslyAbility to work competently, manage own workload and time efficiently to tight deadlines, and to troubleshoot problems without continuous supervisionDetail-oriented and highly organised with the ability to ensure accuracy and rigour in all areas of workKnowledge of ICH GCP and GDPRPrevious use of SmartSheet softwarePrevious management experience of direct reports and the oversight of vendorsPlease note only successful candidates will be contacted.