Study Manager

We are looking for a Research Manager for our Discover Me platform--recruiting participants to a major research study that integrates health and genetic data--providing 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 requirements
• Develop 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 approvals
• Develop and maintain study timelines, including feasibility and recruitment projections
• Oversee the development and ongoing identification and review of study level risk assessments including contingency planning
• Develop and maintain the study budget including site and vendor/supplier budgets
• Develop the study management and monitoring plan and monitor the execution of studies against the study management and monitoring plan, risks, timelines, deliverables and budget
• Develop 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 reports
• Oversee 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 study
• Identify and resolve trends in participant queries
• Contribute 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 studies
• Proficiencies in MS Office Suite experience – Word, Excel, PowerPoint, Excel
• Excellent communication skills and ability to deal with difficult or pressured situations and to work on a number of projects simultaneously
• Ability to work competently, manage own workload and time efficiently to tight deadlines, and to troubleshoot problems without continuous supervision
• Detail-oriented and highly organised with the ability to ensure accuracy and rigour in all areas of work
• Knowledge of ICH GCP and GDPR
• Previous use of SmartSheet software
• Previous management experience of direct reports and the oversight of vendors

Please note only successful candidates will be contacted.