Research Regulatory Operations Manager (Newborns) - 12 Month FTC (we have office locations in Cambridge, Leeds & London)

Company Description

Genomics England partners with the NHS to provide whole genome sequencing diagnostics. We also equip researchers to find the causes of disease and develop new treatments – with patients and participants at the heart of it all.

Our mission is to continue refining, scaling, and evolving our ability to enable others to deliver genomic healthcare and conduct genomic research.

We are accelerating our impact and working with patients, doctors, scientists, government and industry to improve genomic testing, and help researchers access the health data and technology they need to make new medical discoveries and create more effective, targeted medicines for everybody.

Job Description

We are seeking a Research Regulatory Operations Manager for a 12-month fixed-term contract. In this role, you will be part of our Ethics team, managing all research regulatory processes and activities necessary to support the Generation Study and other research projects related to it.

Your work will be crucial in supporting the strategic efforts of the Ethics Lead for Newborns.

Everyday responsibilities include:

Work with the Ethics Lead (Newborns) on defining and implementing research regulatory strategy across the Generation Study.
Integrate regulatory amendments and submissions for the Generation Study, including those for sub-studies and evaluation work.
Prepare and collate study and amendment submissions to the Health Research Authority (HRA) in line with national (IRAS) and local (NHS R&D) requirements.
Take full responsibility for making amendment notifications to study sites, track responses, and escalate where necessary.
Oversee the preparation, submission, and tracking of regulatory documents and relevant updates to recruiting sites for local study approval.
Collaborate with the Mobilisation and Performance Teams to manage protocol deviations and other notifiable events with participating study sites.
Support efficient and compliant set-up, maintenance, and close-down of the study, with Quality Assurance as a key principle.
Act as the regulatory liaison between the Mobilisation, Performance and Ethics team.Skills and experience for success:

Hands on experience of Health Regulatory Authority (HRA) processes, ensuring compliance with regulatory standards and guidelines.
Proficient in completing, reviewing, and submitting Research Application System (IRAS) forms with accuracy and efficiency.
Knowledge of the legal and ethical aspects of research governance, including data protection, consent, and statutory compliance.
Exceptional attention to detail when handling and analysing large datasets, ensuring accuracy, consistency, and data integrity.
Skilled in managing a wide range of administrative tasks, maintaining organised systems to support research and regulatory processes.
Strong communicator with the ability to collaborate seamlessly across cross-functional teams.

Qualifications

Academic qualifications are certainly valued; however, we are more interested in your skills and experience for the role.

Additional Information

Salary from: £50,750

Please note travel of minimum 2-3 days per month to our London office is essential for this role.

Application Requirements:

To help us understand your experience for the role, please provide an example (not more than 300 words) of a project where you have facilitated the HRA and REC aspects, including the IRAS applications, amendments and notifications to sites.  

Closing date for applications - Friday 12th September at midnight.

Being an integral part of such a meaningful mission is extremely rewarding in itself, but in order to support our people, we’re continually improving our benefits package. We pride ourselves on investing in our people and supporting them to achieve their career goals, as well as offering a benefits package including: 

Generous Leave: 30 days’ holiday plus bank holidays, additional leave for long service, and the option to apply for up to 30 days of remote working abroad annually (approval required).
Family-Friendly: Blended working arrangements, flexible working, enhanced maternity, paternity and shared parental leave benefits.
Pension & Financial: Defined contribution pension (Genomics England double-matches up to 10%, however you can contribute more if you wish), Life Assurance (3x salary), and a Give As You Earn scheme.
Learning & Development: Individual learning budgets, support for training and certifications, and reimbursement for one annual professional subscription (approval required).
Recognition & Rewards: Employee recognition programme and referral scheme.
Health & Wellbeing: Subsidised gym membership, a free Headspace account, and access to an Employee Assistance Programme, eye tests, flu jabs.Equal opportunities and our commitment to a diverse and inclusive workplace 

Genomics England is actively committed to providing and supporting an inclusive environment that promotes equity, diversity and inclusion best practice both within our community and in any other area where we have influence. We are proud of our diverse community where everyone can come to work and feel welcomed and treated with respect regardless of any disability, ethnicity, gender, gender identity, religion, sexual orientation, or social background. 

Genomics England’s policies of non-discrimination and equity and will be applied fairly to all people, regardless of age, disability, gender identity or reassignment, marital or civil partnership status, being pregnant or recently becoming a parent, race, religion or beliefs, sex or sexual orientation, length of service, whether full or part-time or employed under a permanent or a fixed-term contract or any other relevant factor.  

Genomics England does not tolerate any form of discrimination, harassment, victimisation or bullying at work. Such behaviour is contrary to