Juice Resource Solutions Limited

Juice Resource Solutions Limited Surrey, UK
12/10/2018
Contractor
Workday Workforce Administration SME: HR Services 6 Month Contract Sunbury on Thames Day rate up GBP 420 depending on Experience The role will provide process subject matter expertise in relation to the WFA processes, specifically Workday related. The role will manage the development and implantation of the strategy, future operating model, processes, collateral and tools needed to deliver the future state WFA services on the Workday solution. The role will manage the aspects/artefacts and to further evolve the foundational services through the work of the Client Solutions team post go-live with the aim of continuous improvement in service level, process efficiency and cost effectiveness. The key responsibilities of the role: Defining, managing, changing and deploying the associated WFA Processes Defining the functional requirements relating to the development of WFA services specific tools and working closely with HRIS to the realisation of these tools Managing team members including contractors and 3rd Party Suppliers Defining, managing and operating the end state process support model for WFA and the continuous improvement of the associated process, services and delivery model The WFA SME is key to the continuous improvement, operation and stability of HR Services operated through the network of regional delivery centres in Client Solutions. The WFA SME has a global remit across all delivery centres from which foundational services are operated and its key interface points are with HRIS (as solutions owners and partners), Country Leads (as stakeholders receiving service or part of SDM) and the delivery centre based Foundational Service Leads (as executors of service into the business) Skills and experience Proven experience in multiple organisational change management roles delivering business change programmes Strong consultative skills Excellent facilitation, communication and data analysis skills Experienced in establishing, building and developing trusted and productive relationships with key stakeholders Experience of leading business development activity in the technology adoption space Experience of working in a multi-cultural environment Strong stakeholder management skills Behaviour Relationship management - maintains and builds effective long term relationships with the delivery centre Foundational Service Leads, external vendors and Country HR Heads Effective communication skills both downwards and upwards, flexible style able to deal with stakeholders at all levels Strong influencing skills - able to gain acceptance to ideas from senior stakeholders and comfortable in the space of challenge and difficult conversations. Align to expected values and behaviours. Critical Experience Experience and detailed understanding of Workday, its construct, scope and process relating to Core HR Experience of working in a Functional role on at least two Workday implementations for large multinational organisations Proven experience of analysing complex Human Resources strategic initiatives in order to translate requirements into simple and standard solutions Proven experience of designing end-to-end solutions with both a process and functional lens in order to deliver in line with desires of a future-state Operating Model Experience of work with or alongside a System Implementation partner Proven Project Management skills built up from leading and embedding change Demonstrable track record of stakeholder management skills and change expertise Due to the volume of applications, we regret that we can only respond to those meeting our above requirements.
Juice Resource Solutions Limited London, UK
12/10/2018
Full time
Clinical Site Manager II/Senior Clinical Site Manager Global Clinical Research Organisation Permanent opportunities GBP 30,000 - GBP 50,000 base (dependent on experience level) + car allowance + Benefits UK travel involved. Homebased/office based opportunities *5/6 roles up for grabs!* OVERVIEW: The Clinical Site Manager (CSM) is the clinical sites' direct point of contact and accountable for managing site quality and delivery from site identification through close-out. The aim of this role is to build the relationship with the site, to be the sole position accountable for the site performance, including driving the site successfully to initiation, the development of a robust patient recruitment strategy, setting up of a system, assessing compliance with regulations and the site's capability to comply with the study needs and recruitment expectations, and problem solving to address and resolve site issues. KEY ACCOUNTABILITIES: Start-Up (from site identification through pre-initiation) - ICSM * Act as the direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase. * Build relationships with investigators and site staff. * Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include: * Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments. * Conduct remote Qualification Visits (QVs). * Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution. * Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation. * Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments. * Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval. * Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy. * Forecast, develop, manage, and revise plans and strategies for: * IRB/IEC and MoH/RA submission/approval, * Site activation, Patient recruitment & retention. * Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner. * Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc. * Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start. * Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections. Maintenance (from initiation through close out) - CSM * Act as the company's direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues. * Build relationships with investigators and site staff. * Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements. * Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary/relevant. * Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication. * Address/evaluate/resolve issues pending from the previous visit, if any. * Follow-up on and respond to appropriate site related questions. * Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action. * Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required. * Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable. * Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements. * Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns. * Conduct remote visits/contacts as requested/needed. Overall Accountabilities from Site identification to Close out - CSM * Ensure timely and accurate completion of project goals and update of applicable trial management systems. * Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required. * Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (eg CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality. * Ensure that assigned sites are audit and inspection-ready. SKILLS/EXPERIENCE REQUIRED: Education: * Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience. Knowledge and Experience: * Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology * Sound problem solving skills. * Able to take initiative and work independently, and to proactively seek guidance when necessary. * Advance presentation skills. * Client focused approach to work. * Ability to interact professionally within a client organization. * Flexible attitude with respect to work assignments and new learning. * Ability to prioritize multiple tasks, and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise. * Willingness to work in a Matrix environment and to value the importance of teamwork. * Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS Office products such as Excel and Word. * Strong interpersonal, verbal, and written communication skills. * Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables. * Effective time management in order to meet study needs, team objectives, and department goals. * Developing ability to work across cultures. * Shows commitment to and performs consistently high quality work. * Ability to successfully work in a ( ' virtual') team environment. * Consulting Skills * Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned. * Attention to detail. * Holds a dri
Juice Resource Solutions Limited London, UK
12/10/2018
Full time
Clinical Site Manager II/Senior Clinical Site Manager Global Clinical Research Organisation Permanent opportunities GBP 30,000 - GBP 50,000 base (dependent on experience level) + car allowance + Benefits UK travel involved. Homebased/office based opportunities *5/6 roles up for grabs!* OVERVIEW: The Clinical Site Manager (CSM) is the clinical sites' direct point of contact and accountable for managing site quality and delivery from site identification through close-out. The aim of this role is to build the relationship with the site, to be the sole position accountable for the site performance, including driving the site successfully to initiation, the development of a robust patient recruitment strategy, setting up of a system, assessing compliance with regulations and the site's capability to comply with the study needs and recruitment expectations, and problem solving to address and resolve site issues. KEY ACCOUNTABILITIES: Start-Up (from site identification through pre-initiation) - ICSM * Act as the direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase. * Build relationships with investigators and site staff. * Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include: * Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments. * Conduct remote Qualification Visits (QVs). * Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution. * Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation. * Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments. * Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval. * Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy. * Forecast, develop, manage, and revise plans and strategies for: * IRB/IEC and MoH/RA submission/approval, * Site activation, Patient recruitment & retention. * Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner. * Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc. * Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start. * Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections. Maintenance (from initiation through close out) - CSM * Act as the company's direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues. * Build relationships with investigators and site staff. * Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements. * Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary/relevant. * Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication. * Address/evaluate/resolve issues pending from the previous visit, if any. * Follow-up on and respond to appropriate site related questions. * Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action. * Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required. * Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable. * Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements. * Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns. * Conduct remote visits/contacts as requested/needed. Overall Accountabilities from Site identification to Close out - CSM * Ensure timely and accurate completion of project goals and update of applicable trial management systems. * Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required. * Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (eg CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality. * Ensure that assigned sites are audit and inspection-ready. SKILLS/EXPERIENCE REQUIRED: Education: * Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience. Knowledge and Experience: * Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology * Sound problem solving skills. * Able to take initiative and work independently, and to proactively seek guidance when necessary. * Advance presentation skills. * Client focused approach to work. * Ability to interact professionally within a client organization. * Flexible attitude with respect to work assignments and new learning. * Ability to prioritize multiple tasks, and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise. * Willingness to work in a Matrix environment and to value the importance of teamwork. * Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS Office products such as Excel and Word. * Strong interpersonal, verbal, and written communication skills. * Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables. * Effective time management in order to meet study needs, team objectives, and department goals. * Developing ability to work across cultures. * Shows commitment to and performs consistently high quality work. * Ability to successfully work in a ( ' virtual') team environment. * Consulting Skills * Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned. * Attention to detail. * Holds a dri
Juice Resource Solutions Limited 21 Ray Mill Road East, Maidenhead SL6 8SW, UK
11/10/2018
Contractor
Interim Manufacturing Manager Global Pharmaceutical Company 6 months initial contract ASAP Start Location: Maidenhead area, Berkshire Rate: Up to GBP 53p.h. (or GBP 425 p.d.) Our client is seeking an interim manufacturing manager (Pharmaceuticals) for an initial 6-12 month contract. The company are one of the world's largest and best known Pharmaceutical companies. KEY ACCOUNTABILITIES: * Evaluate the potential impact of proposed changes on quality and efficacy * Support the change control process when applicable * Participate where necessary in QA-led investigations of process deviations and customer complaints. Support manufacturing troubleshooting activity and propose CAPA where applicable * Evaluate manufacturing instructions, specifications and amendment to each. * Ensure that current pharmacopeial requirements are met where applicable * Perform and support raw material evaluation and qualification * Investigate process improvements and oversee the process validation, ensuring adequate documentation is available to support successful registration of projects * Support request for information requests which may arise on regulatory variation submission * Support request for information requests which may arise on regulatory variation submission * Update company Specification systems such as GSS, CONNECT, etc. * Manage the APR process * Create pharmaceutical reports. * Participate in various cross-disciplinary groups in an expert capacity. * Support local manufacturing plant in an expert capacity * Actively participate in the Tech Transfer Team * Contribute expertise on product and process engineering. * Support Process and Analytical optimization, development and validation as required * Ensure transfer compliance with current company procedures * Develop product development strategies for current products on market * Contribute Expertise on product and process development * Actively participate in establishing and developing the process on a production scale * Create and/or Review up-scaling reports * Ensure that adequate documentation is available to support successful registration of products * Support commercialization of secondary market launches of new product introductions * Ensure that adequate documentation is available to support successful registration of projects * Management of Third Parties * Actively participate in the selection, due diligence and evaluation of Third Party partners * Management of technical relationship with Third Party and provide technical supervision to assure that company products are produced according to company and International standards * Maintain necessary good manufacturing practice (GMP) skills through training, technical review and SOPs * Have a close collaboration with the Supply Chain * Continuously update new research findings and techniques * Be responsible for personal development (active participation in planning and employee reviews as well as creation and implementation of personal development plans) SKILLS/EXPERIENCE REQUIRED: Educational: Minimum of Bachelors degree with a major in chemistry, chemical engineering or pharmaceutics or equivalent degree. Work Experience: * A minimum of 8 years in a pharmaceutical manufacturing or product development environment with a major emphasis on multi-ingredient finished dose formulations. * Experience with non-prescription ingredients used in cough, cold & allergy preparations and analgesics is a distinct advantage. * Comprehensive understanding of quality compliance knowledge within EU and good understanding of GxP systems * A demonstrated business partner and ability to bring together multi-disciplined technical staff in order to problem-solve. * Technical writing and documentation review abilities * Project management, communication and prioritization skills. * Demonstrable experience of working with external manufacturers Due to the high volume of applications we receive we are not able to get back to everyone who applies. Therefore if you have not heard back from Juice Resource Solutions within 7 days please assume that your application has been unsuccessful however we will contact you if suitable roles come up that match your skill set.
Juice Resource Solutions Limited 21 Ray Mill Road East, Maidenhead SL6 8SW, UK
09/10/2018
Contractor
Interim Manufacturing Manager Global Pharmaceutical Company 6 months initial contract ASAP Start Location: Maidenhead area, Berkshire Rate: Up to GBP 53p.h. (or GBP 425 p.d.) Our client is seeking an interim manufacturing manager (Pharmaceuticals) for an initial 6-12 month contract. The company are one of the world's largest and best known Pharmaceutical companies. KEY ACCOUNTABILITIES: * Evaluate the potential impact of proposed changes on quality and efficacy * Support the change control process when applicable * Participate where necessary in QA-led investigations of process deviations and customer complaints. Support manufacturing troubleshooting activity and propose CAPA where applicable * Evaluate manufacturing instructions, specifications and amendment to each. * Ensure that current pharmacopeial requirements are met where applicable * Perform and support raw material evaluation and qualification * Investigate process improvements and oversee the process validation, ensuring adequate documentation is available to support successful registration of projects * Support request for information requests which may arise on regulatory variation submission * Support request for information requests which may arise on regulatory variation submission * Update company Specification systems such as GSS, CONNECT, etc. * Manage the APR process * Create pharmaceutical reports. * Participate in various cross-disciplinary groups in an expert capacity. * Support local manufacturing plant in an expert capacity * Actively participate in the Tech Transfer Team * Contribute expertise on product and process engineering. * Support Process and Analytical optimization, development and validation as required * Ensure transfer compliance with current company procedures * Develop product development strategies for current products on market * Contribute Expertise on product and process development * Actively participate in establishing and developing the process on a production scale * Create and/or Review up-scaling reports * Ensure that adequate documentation is available to support successful registration of products * Support commercialization of secondary market launches of new product introductions * Ensure that adequate documentation is available to support successful registration of projects * Management of Third Parties * Actively participate in the selection, due diligence and evaluation of Third Party partners * Management of technical relationship with Third Party and provide technical supervision to assure that company products are produced according to company and International standards * Maintain necessary good manufacturing practice (GMP) skills through training, technical review and SOPs * Have a close collaboration with the Supply Chain * Continuously update new research findings and techniques * Be responsible for personal development (active participation in planning and employee reviews as well as creation and implementation of personal development plans) SKILLS/EXPERIENCE REQUIRED: Educational: Minimum of Bachelors degree with a major in chemistry, chemical engineering or pharmaceutics or equivalent degree. Work Experience: * A minimum of 8 years in a pharmaceutical manufacturing or product development environment with a major emphasis on multi-ingredient finished dose formulations. * Experience with non-prescription ingredients used in cough, cold & allergy preparations and analgesics is a distinct advantage. * Comprehensive understanding of quality compliance knowledge within EU and good understanding of GxP systems * A demonstrated business partner and ability to bring together multi-disciplined technical staff in order to problem-solve. * Technical writing and documentation review abilities * Project management, communication and prioritization skills. * Demonstrable experience of working with external manufacturers Due to the high volume of applications we receive we are not able to get back to everyone who applies. Therefore if you have not heard back from Juice Resource Solutions within 7 days please assume that your application has been unsuccessful however we will contact you if suitable roles come up that match your skill set.