Compliance Associate

Job title:

Compliance Associate

Company

Lifelancer

Job description

Job Title: Compliance AssociateJob Location: Milton Keynes, UKJob Location Type: RemoteJob Contract Type: Full-timeJob Seniority Level: Mid-Senior levelDo you enjoy working on a range of projects and with different teams? Do you want to be part of an innovative & people orientated company? Then MRN could be the one for you!About MRNAt MRN, our focus is on increasing accessibility to clinical trials for a diverse population of patients. We achieve this by utilizing the Decentralized Clinical Trial (DCT) model, which involves conducting trials directly in the patient’s communities. For decentralized trials to be accessible to all patients, it’s essential to have a diverse workforce. A diverse workforce brings various perspectives and experiences that can help identify and address potential participation barriers. At MRN, we value diversity and want to hear from people who represent our diverse patient population.About The Role…We are now looking for a talented Compliance Associate to join our team. As a Compliance Associate, you will contribute to the strategic design, implementation and delivery of quality management and quality assurance to the MRN global and local operational teams as part of the Quality Management department. You will ensure all functions, programs and projects for the MRN (and all partners) at all locations are working in compliance with MRN’s quality standards and written procedures, Health Authority (HA) guidelines and regulations, and local laws. This includes all clinical trials, pharmacovigilance, data management and information technology. Ensure full, compliant documentation is present in collaboration with MRN’s functions: Nursing, Pharmacy, Vendor Services, Project Management, Regulatory, Training, HR, IT, Corporate Services and other relevant support functions.The Compliance Associate Will Be Responsible For

• Support where needed study reviews (as per the approved schedule) by assessing project files and archives to ensure completeness and compliance with regulations such as GCP, GMP and GDP along with medical and nursing requirements.
• Support and participate customer & vendor audits and regulatory inspections.
• Supports stakeholders in preparing for related Health Authority inspections.
• Assists in Back-room Inspection activities and support including assistance in preparation and responses to Health Authority inspections and customer audits
• Assists in the development and implementation of effective training programs that support MRN’s quality objectives, and in the capture and dissemination of lessons learned
• Monitoring and communication of audit and inspection findings.
• Collate trend analyses, quality metrics and key performance indicators from the business and report to the Operating Board each month. Report quality trends to division heads on a regular basis

Skills, Experience, And Qualifications…We are looking for a talented, highly experienced and commercial aware quality and compliance leader who is results driven, solution focused and has the passion, knowledge and expertise to drive QM across the organisation.We are interested to hear from individuals with the following experience:Essential

• Working knowledge of established project management tools
• At least 4 years experience in operational activities within clinical trials
• Experience in a clinical research environment with strong working knowledge of ICH-GCP E6 regulations
• Working knowledge of the drug development process, quality assurance procedures and policies, and quality evaluation techniques

Desirable:

• Certified in an established project management methodology
• Knowledge of worldwide GxP compliance regulations
• Able to present information with confidence and enthusiasm

Where: This role will be office/home based (remote and hybrid working options are available).Contract Type: This is a Full-Time, Fixed Term Contract positionWhy Join us?At MRN we offer a number of benefits designed to promote your work-life balance and make your time at MRN enjoyable and rewarding. We encourage all our employees to be ambitious, and offer great training, mentoring and career development opportunities.Our Core Benefits Include

• generous paid leave (including an additional day off for your birthday)
• medical and life insurance cover
• pension / 401(k) scheme
• bonus scheme

We also know how important health and wellbeing are and offer free independent 24/7 help and advice for work and home related challenges: as well as physical wellbeing support and online 24/7 access to healthcare professionals. MRN respect people’s different working preferences and the need for a healthy work-life balance and offer flexible working hours and remote working.So, what’s next… If this sounds like you and you’d like to learn more, we would love to hear from you! Please click ‘ Apply Now ’ or email .MRN is proud to be an equal opportunities employerWe are an equal opportunity employer who values diversity. Our aim is to work simultaneously to promote a more inclusive and safer environment for everyone, which attracts all candidates and portrays our commitment to celebrate and promote diversity. Our aim is to ensure your application, interview process and transition to MRN is simple and personal. If you require any adjustments for any part of the application process, or to perform the essential functions of a position, please get in touch.Data Protection – Your RightsShould you apply for a job opportunity at the MRN, we wish to inform you that it is our intention to retain the personal data provided by you for up to 2 years from the date it is received, at which point you will be asked to provide new consent. If you have any questions or concerns regarding our processes and how your personal data will be stored, please contact us for further reassurance.DBS DisclosureDBS Disclosure may be requested in the event of being offered the position. Having a criminal record will not necessarily prevent you from working with us. This will depend on the nature of the position and the circumstances and background of the offence(s).Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.For more details and to find similar roles, please check out the below Lifelancer link.

Expected salary

Location

Milton Keynes

Job date

Mon, 27 Jan 2025 23:13:33 GMT

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