Regulatory & Study Start Up Specialist - UK - 0.7 FTE
1 month ago
RBW Consulting are partnered with a leading mid-sized CRO in their search for a Regulatory & Study Start Up Consultant to work remotely in the UK.
This is an initial 4 month contract for an estimated 0.7 FTE.
Rate is negotiable.
Must haves
- Be proficient in preparing regulatory submissions in the UK (combined review through IRAS, Radiation assurance, ARSAC). Must have proven recent experience on this, and be able to work independently on this (ie: completing medicines form, radiation form, providing advice on required documents for regulatory submissions, etc).
- Be proficient in creating budget using Interactive Costing Tool (iCT) in CPMS.
- Be proficient in performing country adaptation for the UK for ICF’s.
Duties
- Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
- Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
- Interaction with CA/EC for study purposes and handling responses to the CA/EC.
- Providing regular updates about CA and EC submissions to Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.
- Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
- Prepare/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
- Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.
- Review and manage collection of essential documents required for site activation/IMP release.
- Customize country/site specific Patient Information Sheet and Informed Consent Forms.
- Responsible for/facilitates the translation and co-ordination of translations for documents required for submission.
- Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
- Act as SME for collection and maintenance of site level critical path to IMP Release data points such as Competent Authority, local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
- When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
- Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within PfM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
- May support the clinical team performing Pre-Study Site Visits
- May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
- May support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
- May support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
- May interact with clients to provide activation readiness status updates, request documents or document review and participate in proposal activities, including slide development and client presentation as required.
- Consultant may be asked to undertake other related duties as may be needed.
Apply here and Harry Henson will be in touch to discuss your application further
-
United Kingdom RBW Consulting Full timeRBW Consulting are partnered with a leading mid-sized CRO in their search for a Regulatory & Study Start Up Consultant to work remotely in the UK. This is an initial 4 month contract for an estimated 0.7 FTE. Rate is negotiable. Must haves Be proficient in preparing regulatory submissions in the UK (combined review through IRAS, Radiation assurance,...
-
United Kingdom RBW Consulting Full timeRBW Consulting are partnered with a leading mid-sized CRO in their search for a Regulatory & Study Start Up Consultant to work remotely in the UK. This is an initial 4 month contract for an estimated 0.7 FTE. Rate is negotiable. Must haves Be proficient in preparing regulatory submissions in the UK (combined review through IRAS, Radiation assurance,...
-
United Kingdom RBW Consulting Full timeRBW Consulting are partnered with a leading mid-sized CRO in their search for a Regulatory & Study Start Up Consultant to work remotely in the UK. This is an initial 4 month contract for an estimated 0.7 FTE. Rate is negotiable. Must haves Be proficient in preparing regulatory submissions in the UK (combined review through IRAS, Radiation assurance,...
-
Senior Consultant
2 weeks ago
United Kingdom VRS Regulatory Full timeAn excellent opportunity to join an ambitious UK based chemical regulatory compliance consultancy. Working closely with the highly experienced and respected Principal Consultant, you will undertake a range of regulatory activities including: Study monitoring Writing up study reports Risk assessments Dossier preparation Developing regulatory strategy ...
-
Senior Consultant
2 weeks ago
United Kingdom VRS Regulatory Full timeAn excellent opportunity to join an ambitious UK based chemical regulatory compliance consultancy. Working closely with the highly experienced and respected Principal Consultant, you will undertake a range of regulatory activities including: Study monitoring Writing up study reports Risk assessments Dossier preparation Developing regulatory strategy...
-
Senior Consultant
2 weeks ago
United Kingdom VRS Regulatory Full timeAn excellent opportunity to join an ambitious UK based chemical regulatory compliance consultancy. Working closely with the highly experienced and respected Principal Consultant, you will undertake a range of regulatory activities including: Study monitoring Writing up study reports Risk assessments Dossier preparation Developing regulatory strategy ...
-
Senior Consultant
2 weeks ago
United Kingdom VRS Regulatory Full timeAn excellent opportunity to join an ambitious UK based chemical regulatory compliance consultancy. Working closely with the highly experienced and respected Principal Consultant, you will undertake a range of regulatory activities including:Study monitoringWriting up study reportsRisk assessmentsDossier preparationDeveloping regulatory strategyConsortia...
-
Senior Consultant
2 weeks ago
United Kingdom VRS Regulatory Full timeAn excellent opportunity to join an ambitious UK based chemical regulatory compliance consultancy. Working closely with the highly experienced and respected Principal Consultant, you will undertake a range of regulatory activities including:Study monitoringWriting up study reportsRisk assessmentsDossier preparationDeveloping regulatory strategyConsortia...
-
Senior Director, Study Start Up Head
2 weeks ago
United Kingdom Astellas Europe Full timeSenior Director, Study Start Up Head About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening...
-
United Kingdom VRS Regulatory Full timeExciting opportunity to join the regulatory affairs team at an established and highly reputable chemical regulatory science consultancy. This is expansion to cover an increasing workload. The role is delivery focussed with no commercial or business development aspects. We are looking for a regulatory person for a purely regulatory delivery role. This role...
-
Specialist – Regulatory Affairs PPP
2 months ago
United Kingdom VRS Regulatory Full timeAn opportunity to join the Regulatory Affairs team at an R&D focussed global PPP company. You will:Manage a portfolio of plant protection products in specific geographical territoriesDevelop regulatory strategy Become the subject matter expert on the regulations/guidelines in your territory. As a regulatory Specialist, you will develop regulatory strategy...
-
Regulatory Intelligence Associate
2 weeks ago
United Kingdom RBW Consulting Full timeRBW Consulting are partnered with a leading mid-sized CRO in their search for a Regulatory & Study Start Up Consultant to work remotely in the UK. This is an initial 4 month contract for an estimated 0.Be proficient in preparing regulatory submissions in the UK (combined review through IRAS, Radiation assurance, ARSAC). Must have proven recent experience...
-
Regulatory Intelligence Associate
2 weeks ago
United Kingdom RBW Consulting Full timeRBW Consulting are partnered with a leading mid-sized CRO in their search for a Regulatory & Study Start Up Consultant to work remotely in the UK. This is an initial 4 month contract for an estimated 0.Be proficient in preparing regulatory submissions in the UK (combined review through IRAS, Radiation assurance, ARSAC). Must have proven recent experience...
-
Regulatory Specialist
2 weeks ago
United Kingdom William Parker Group Full timeAre you ready to take the next step in your regulatory affairs career? We are partnering with a leading pharmaceutical organisation to find a skilled Regulatory Affairs Specialist who is passionate about ensuring compliance and safeguarding patient safety. This exciting role offers the opportunity to work across UK, EU, and global markets. Key...
-
Regulatory Specialist
2 weeks ago
United Kingdom William Parker Group Full timeAre you ready to take the next step in your regulatory affairs career? We are partnering with a leading pharmaceutical organisation to find a skilled Regulatory Affairs Specialist who is passionate about ensuring compliance and safeguarding patient safety. This exciting role offers the opportunity to work across UK, EU, and global markets. Key...
-
Regulatory Specialist
2 weeks ago
United Kingdom William Parker Group Full timeAre you ready to take the next step in your regulatory affairs career? We are partnering with a leading pharmaceutical organisation to find a skilled Regulatory Affairs Specialist who is passionate about ensuring compliance and safeguarding patient safety. This exciting role offers the opportunity to work across UK, EU, and global markets. Key...
-
Regulatory Specialist
3 weeks ago
United Kingdom William Parker Group Full timeAre you ready to take the next step in your regulatory affairs career? We are partnering with a leading pharmaceutical organisation to find a skilled Regulatory Affairs Specialist who is passionate about ensuring compliance and safeguarding patient safety. This exciting role offers the opportunity to work across UK, EU, and global markets.Key...
-
Regulatory Specialist
3 weeks ago
United Kingdom William Parker Group Full timeAre you ready to take the next step in your regulatory affairs career? We are partnering with a leading pharmaceutical organisation to find a skilled Regulatory Affairs Specialist who is passionate about ensuring compliance and safeguarding patient safety. This exciting role offers the opportunity to work across UK, EU, and global markets.Key...
-
Regulatory Specialist and Senior Specialist
2 weeks ago
United Kingdom William Parker Group Full timeAre you ready to take the next step in your regulatory affairs career? We are partnering with a leading pharmaceutical organisation to find a skilled Regulatory Affairs Specialist who is passionate about ensuring compliance and safeguarding patient safety. Regulatory Compliance : Ensure adherence to regulatory requirements across UK, EU, and global...
-
Regulatory Specialist and Senior Specialist
2 weeks ago
United Kingdom William Parker Group Full timeAre you ready to take the next step in your regulatory affairs career? We are partnering with a leading pharmaceutical organisation to find a skilled Regulatory Affairs Specialist who is passionate about ensuring compliance and safeguarding patient safety. Regulatory Compliance : Ensure adherence to regulatory requirements across UK, EU, and global...