We are currently seeking candidates to fill a number of exciting positions, including a Research Manager to join our rapidly growing team at Omnigen Biodata Ltd ("Omnigen") based in the centre of Cambridge, UK.
Omnigen is a research and development company building the Discover Me Platformt — consenting the wider public in the UK and South Africa to build a database and community to support precision medicine studies and trials.
The Research Manager will manage operational activities related to the planning, implementation, and data outputs of Omnigen studies. The activities will be focused on our Discover Me platform.
To learn more about our key platform please visit:
(note: please do not send job-related queries via the Discover Me study contact details; only applicants contacting us via the Indeed portal will be responded to).
Key responsibilities of the role include:
* develop and execute study-specific plans
* contribute to the development of study protocols
* work with the Head of Research to develop study timelines, including feasibility and recruitment projections
* plan and track site level activities and performance and manage issues relating to execution
* monitor the execution of studies against timelines, deliverables and budget
* conduct QC reviews of essential documents
* maintain oversight of study procurement and logistical aspects of the study (e.g. study equipment)
* maintain the TMF including set up and management of the ISF
* manage vendor selection and associated plans, timelines, budgets and deliverables
* liaise with vendors and suppliers as required
* respond to and track participant queries
* participate in the development of study systems and processes e.g. sample management processes, feedback of results to participants
* lead and participate in study team meetings where relevant
* ensure timelines and deliverables are communicated to all personnel assigned to the study
* ensure appropriate quality measures are in place
* execute inspection readiness activities (TMF review, story board generation)
* contribute to the risk management plans
* supervise direct reports and conduct performance reviews (where relevant)
* participate in process improvement
Qualifications, skills and experience:
The Research Manager will have the minimum qualifications of a bachelor's degree (BSc, BA or RN equivalent) in a biological or science-related field.
In addition to the above: broad experience of working in life sciences or a medically-related field including general clinical research experience is required.
Preferred requirements:
* demonstrated experience of conducting epidemiological field studies or clinical research studies
* an understanding of the regulatory environment for conducting research studies
* ability to work competently, manage his/her 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
* previous management experience of direct reports and the oversight of vendors
* knowledge of ICH GCP and GDPR
Starting salary is dependent on qualifications and relevant experience.
Please submit a copy of your CV with a covering letter summarising your suitability for the role.
Please note only successful candidates will be contacted.
This is a hybrid role with two days in our Cambridge office.
Benefits:
* Hybrid working and flexible hours
* Company pension
Job Types: Full-time, Permanent
Work Location: Hybrid remote in Cambridge CB1 3NA
Reference ID: OMN_StudyManager