Our client: Russian pharmaceutical company, which is a leader in research, production and promotion of original biotechnological products in the field of hemophilia, tuberculosis, multiple sclerosis, oncological and cardiovascular diseases treatment.
My client is a leading Bio-Pharma organisation based in West LondonThey are seeking a Senior Clinical Trial Management Associate on a 12 month contract. The role will involve assisting global trial managers on Phase Ib-III clinical studies, with a strong emphasis on the EMEA region.The successful candidate will be a member of the Global Study team overseen by a Clinical Program Manager. You will work across several studies, including involvement from study start-up through study close-out activities, and will work with the CRO to execute the study to agreed timelines and budget. Essential Duties and Job Functions: Must meet all requirements for Clinical Trial Management Associate position and have demonstrated proficiency in all relevant areas.Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROsAssist global trial managers with set-up of central labs and study vendors as required, including liaising with study management CRO to ensure site training and timely initiationPerforms accompanied visits with CRO CRAs to ensure correct study procedures according to company SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as requiredUnder supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, study plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures under close supervision.Review of trip reports generated by CRO CRAsCommunicates and collaborates with other functional groups including but not limited to Clinical Research, Regulatory Affairs, Development Business Operations (DBO), Clinical Supply Management (CSM) and Pharmacovigilance (PVE) to ensure efficient management of study activitiesAssists with the preparation and organization of international investigator meetingsAssists in preparation of safety, interim and final study reports, including resolving data discrepancies.Performs administrative duties in a timely manner as assignedTravel is required up to 20% Experience, knowledge and skills:Educated to degree level or equivalent within a relevant scientific disciplineMinimum 3 years relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.CRA experience preferred.Excellent verbal, written, interpersonal and presentation skills are required.Must be familiar with routine medical/scientific terminology.Must be familiar with Word, PowerPoint, and Excel.Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.Parkside Recruitment Ltd is acting as an Employment Business in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.
My client has a secure technology-empowered healthcare platform that unites patients, doctors, insurance, labs, and pharmacies into one simple Healthcare Application. It is HQ in Jakarta, Indonesia, and is the world's most unique and efficient medical startup.
My client is a leading research-based bio-pharmaceutical organisation they have a great to opportunity for an Associate Director - Medical Affairs.This is a 15n month contractHead of Medical Affairs Operations - Associate Director Skills for Position: o Demonstrated ability to manage several medical projects within designated program budgets and timelines is required. o Demonstrated excellence in complex project management and effectively managing multiple projects/priorities is required. o Support team members and empower them to complete deliverables efficiently and effectively. o Ability to initiate and lead departmental or interdepartmental strategic initiatives. o Proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers. o Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problems o Organize and manage Medical project team meetings, ensuring timely, efficient, and action-oriented operations. o Manage external collaboration project and all associated interactions (e.g. meetings, communications etc.) with the partner agencies and ensure agencies deliver projects in accordance to agreed timelines, scope, budget and compliance o Direct project communications to relevant team members and ensures that all stakeholders (internally and externally) are fully informed and knowledgeable of project activities and their status. o Implement best-in-class project management processes and tools/templates such as project schedules, Gantt charts, action/decision logs, risk registers, SharePoint site etc. o Provide inputs on behalf of the LT for the LE process. Manage cross-functional initiatives/projects to enable advancement of sciences and improve alignment and efficiency. o Prepare agenda, minutes, and action items for Leadership Team meetings Knowledge: o Excellent verbal, written, interpersonal skills, and ability to work with multifunctional teams o Must be able to effectively communicate progress toward milestones, opportunities, and risks to all stakeholders. o Must exhibit high emotional intelligence, with demonstrated ability to successfully negotiate through challenging situations and difficult conversations. o Possess a strong ability to build trust, along with demonstrated ability to drive, lead and influence colleagues across the organization to achieve team, department and corporate goals. o Must be a team player, focusing on shared goals, being flexible and applying skills where required, respecting others, listening to others' views and value others' contribution, sharing information and good ideas across organizations and celebrating/recognizing accomplishments. o Must have strong leadership skills and ability to effectively develop teams o Must be comfortable and efficient in a fast-paced, dynamic and growing environment. o ability to prioritize and execute tasks both as an individual contributor and in a team-based setting o History of motivating others to deliver to important milestones while maintaining a positive, transparent and collaborative team environment o Capable of assessing and updating detailed project timelines in meetings to guide and align study team members o Ability to evaluate meeting minutes and materials for required updates to project timelines o Ability to work on complex and multiple projects while exercising critical thinking with minimal supervision o Solid attention to detail and excellent organization skills o Ability to establish priorities, operate with a sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members o Demonstrates problem solving skills, demonstrates leadership skills, self-motivated and adaptable to a dynamic environment o Computer skills including proficiency in the use of Microsoft Project, Word, Excel, PowerPoint, and organization tools o Proficient with SharePoint with filing systems is desirable o Ability to deal with time demands, incomplete information or unexpected events o Must display strong analytical and problem solving skills o Occasional travel to other company locations as requested. Requirements: o At minimum, a bachelor's degree in nursing, science or health related field required, higher degree, MSc, PhD preferred o Medical Affairs Experience o Project manager/Management experience Parkside Recruitment Ltd is acting as an Employment Business in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.
The client is a leading provider of business and IT solutions We are particularly passionate about IT because of our employees and especially because of our customers. As one of the leading providers of business and IT consulting they offer end-to-end consulting across the entire value and process chain: from the overall strategic concept to the sustainable design of efficient processes, their implementation in IT and safe operation of IT systems. Different. New. Revolutionary. Disruptive. There are many words for the especially in corporate cultures. We have been changing the world with new communication and information technologies for over half a century. We are consultants, researchers, developers, project managers, implementers and doers in one. With the freedom to think, to be creative and to always find new ways. For them it is the innovation and diversity belong together, which is why we rely on diverse teams and actively promote equal opportunities. They are looking for colleagues who want to help shape the future of our customers and the digital age. They combine global presence with local market knowledge and offer professional IT services from consulting and system development to outsourcing. Supply chain management means intelligently controlling process chains. As a partner to our customers, we design changes at the corporate, organizational, process and system level in order to strengthen the sustainable success of our customers in global markets. In local projects, we support the development of tailor-made solutions in a wide variety of sectors of global companies. We are looking about you as new team member of our SAP Team
For our clients, a world's leading animal health company, we are currently looking for a Senior Regulatory Affairs Manager (m/f/d) Animal Health in Cuxhaven or in Home Office (possibly with an office at another company location in Europe).
1. 负责起草、审核公司所有经济合同及涉外合同并提出法律指导意见； Responsible for draft and review all economics and foreign contracts and provide professional legal advice. 2. 负责对公司重大经营决策及经营项目提供法律咨询和解决方案； Provide legal advice and solution for company major business decision-making and business projects. 3. 参加各类商务谈判，合同及其他法律文件的草拟和审查；合同签订后的跟踪检查；规范涉外法律文件的管理流程； Participate in drafting and reviewing all business negotiations, contracts and other legal documents, follow up and inspect contract signing， regulate management process of foreign legal documents. 4. 参与集团指定的其他投资、合资或其他项目的法律支持工作，包括但不限于：组织立项前的法律风险评估工作；参与项目谈判等。 Provide legal support for Group investments, joint ventures or other projects , including but not limited to: legal risk assessment before projects establishment and participate in project negotiations activities. 5. 公司纠纷的管理工作，包括：在纠纷的非诉阶段与对方展开谈判；在纠纷进入法律程序后监督和协调纠纷的处理； Handle and manage all disputes, including: negotiate in non-litigation period, handle and coordinate dispute into the legal process 6. 开展法律培训，做好与业务相关的国际案例研究和宣传等； Provide legal training, study and public relevant international cases 7. 部门安排的其他工作 Other tasks assigned by manager.