RB is different : good enough’ isn’t good enough here.
RB is the world's leading consumer health and hygiene company, We work with the best people to challenge conventional thinking and keep giving people innovative solutions for healthier lives and happier homes, through our brands like Nurofen, Strepsils, Mucinex, Dettol, Lysol, Finish and Vanish.
A fantastic opportunity is available for a Senior ClinicalStudy Manager to join our Clinical Operations team based in any UK location.
Our Evidence Generation and Clinical Research teamgenerates high quality scientific evidence by designing and conducting clinicaltrials.
This provides the information and data we need to bring our products tomarket and to meet consumers’ needs.
We prove that our products work, and work safely,by setting-up, conducting and reporting clinical studies with operationalexcellence, ensuring our products’ uniqueness is adequately highlighted and toanswer meaningful scientific questions.
The responsibilities of the SeniorClinical Study Manager will be :
To deliver and coach best practices in clinicalstudy conduct, ensuring projects timelines and business objectives are met inaccordance with statutory requirements, ICH-
GCP / ISO and other applicablerequirements.
Manage andoversee clinical studies (IMP, device, cosmetics) of low to high complexity ina single country or across multiple regions.
Leadthe study specific activities during the setup, conduct and close-out ofstudies for different Health Relief and Health Wellness RB brands.
Working in a matrix structure, the CSM buildseffective relationships with study team members, ensuring successful conductand delivery of clinical studies to agreed timelines and budgets, in ahighly-regulated environment.
Provide clinicalinput into clinical studies and initiatives (US, EU and any other territory inwhich RB operates) through an understanding of clinical study and regulatoryrequirements and clinical oversight.
Critically readand evaluate relevant literature on clinical methodologies, health outcomes,study designs and results from existing literature and communicate content toproject teams.
Ensureappropriate assessment, selection and management of vendors for outsourcedactivities.
Ensure studydesigns and endpoints for planned clinical studies are in line with therequired standards (i.e. ICH-GCP, ISO, any local regulatory standards) and areoptimal for meeting the study objectives.
Author or reviewProtocols and Clinical Study Reports.
Author or reviewvarious other study related documentation (Vendor Oversight Plan, MonitoringPlan, Data Management plan, Safety Management Plan, etc).
Assist in filingessential study documents and correspondence in the TMF.
Do you have?
A thorough understanding of the entireprocess of conducting a clinical study.
A process-driven mentality and are you ableto influence without authority in a matrix organisation.
The skills to manage conflicting prioritieswith evolving and often challenging timelines.
Experience in managing communications withexternal vendors.
In depth and up to date knowledge of GoodClinical Practice and other regulatory standards (e.g. ISO 14155).
Excellent time management skills &project management experience
Extensive clinical development experience, preferablymanaging clinical studies in a clinical or medical department in a pharmaceutical / consumerhealthcare / cosmetic industry or at a CRO or clinical vendor.
Bachelor’sor Master’s degree in science or a biology-related field with an advanceddegree and / or certification preferred.
Pro-activeand self-directed with a high level of initiative and persistence.
Goodinterpersonal skills, ability to operate successfully in various teamcapacities and in a multi-cultural environment.
Flexible,being able to work across different clinical study categories (IMPs, MedicalDevices, Cosmetics).
A clear and logical thinker with the ability torecognise patterns and develop innovative solutions.
InReturn RB offer very competitive salaries with excellent benefits and thechance to progress your career within a truly Global organisation.
Apply Now for a chance to really change the game!