2366 joburi in Servicii medicale

Clinical Study Manager: HIV Global Clinical Study Management of four late phase HIV studies (inhouse and outsourced) currently in maintenance/close-out stages. With direction from senior clinical staff, collaborate with clinical operations functional groups (regional monitoring (inhouse studies), data management, statistics, clinical supplies and operations management teams) and service providers/vendors to ensure on time delivery of studies to required quality standards. Outsourced studies: Work closely with the CRO study/project managers and address any study related questions, address issues related to study drug supply. Assist in the management of CROs and/or other outsourcing partners as appropriate. This would include global CRO contract renewal/extension, additional vendor contracting, management and oversight. Maintaining relationships and monitor performance of CRO's and other vendors as appropriate. Inhouse studies: Work closely with the local operating country study managers and address any study related issues. Maintaining relationships and monitor performance of vendors as appropriate. Manage study conduct and close-out activities including: Medical writing: Clinical study report writing Protocol and ICF amendments as appropriate Country and site close out, including managing patients transitioning from study to commercial supplies. Ensure accurate maintenance and archiving of study records including eTMF. Escalate issues as needed to the Clinical Delivery Lead/Medical Monitor. Manage the storage of retained human biological samples from ongoing and additional closed studies including maintenance of trackers and manage invoicing. Provide input into identifying implications of study progress upon overall timeline goals conduct plans. Accountable to ensure compliance with GSK and CRO SOPs (as appropriate) and GCP. Oversight of final close out of studies (in last stages of close out/reporting) to required SOPs/Policies and standards. This would include the transition of subjects to commercially available product on a by country basis and supporting countries in implementing local strategies. This role will be working on GSK inhouse and outsourced studies with key HIV assets for ViiV Healthcare. It can be US or UK based. The successful candidate will have global study management experience in clinical operations, be a team player with a focus on excellence and proven operational delivery. They should have an aptitude for clinical systems, can do attitude, with the ability to work across studies within a complex Matrix and fast paced environment. Some flexibility is required to work with the wider global team in different time zones. Experience in medical writing (ie study report generation) is desired. Previous HIV or GSK experience would be preferable but is not essential.

Medical Liaison Manager Contract 6/12 Months + Remote/Field Based Sentinel are working with a with a leading global pharmaceutical company, searching for an experienced Medical Affairs Expert with field-based experience as a Medical/Scientific Liaison. This is a dual role - with a roughly equal split of field and office-based activities. Currently the field based work is being done by video conference but this will return to the field as and when is appropriate based on safety assessments and government guidelines. This part of the role will focus on providing field based medical/scientific support around our client's disease area and products as deemed appropriate within the regulatory framework. The second role is to proactively contribute, enrich and execute the medical strategy in collaboration with her/his management. This will involve developing scientific, medical presentations for face-to-face meetings and gathering insights/data through interactions and advisory boards. MLM key responsibilities: Delivery and execution of medical plan Ensure aligned medical scientific communication to external stakeholders via 1:1 interactions and group presentations Develop, initiate and execute advisory board strategy Capture systematic and structured medical insights through scientific exchange for consolidation at the regional medical level Coordinate research agreements/Investigator initiated trials in the assigned geographic area Build and deliver a strong thought leader scientific collaboration/engagement plan Plan and execute affiliate specific medical educational activities, scientific meetings and symposia Generate and adapt medical material for relevant external engagement Requirements: Higher degree of medical or scientific discipline (Pharm D or PhD, MBChB or equivalent). At least 2 years' experience in either/both medical affairs/medical field role in industry. Autonomous in medical event organisation. Strong customer orientation, externally focused mindset and science oriented. Good customer-relationship and networking capabilities. Excellent interpersonal and organisational skills Appropriate Skills and Knowledge in Research, Pharmacovigilance, Legal, and Pharmaceutical Compliance. Ability to support and set up an annual medical action plan In addition to the above, experience in neurosciences and specifically pediatric neurology would be highly desirable. Please apply now for more details! Your application with Sentinel Sentinel is an award-winning recruitment and consulting company with offices in the UK, Czech Republic, and Switzerland. We work with global brands, ambitious start-ups, and leading recruitment outsourcers, ensuring access to exceptional talent through permanent, contingent labour, and statement of work services. Get in touch today for new opportunities, or guidance on sourcing strategies, salary and rate benchmarking. We aspire to provide great service to all applicants. If we think you're right for the role, we'll be in touch as soon as possible. If not, we'll keep you updated with other opportunities in your field. To apply for this role or more information, please apply with your up to date CV or email (see below) Joel Hawkins - Key Accounts Manager (see below)  

As a part of the Clinical Project team (CPM) you will lead medical writing and editing projects for Late Stage Clinical Development organizations, partnering closely with key stakeholders: Clinical Science Leaders (CSLs), Medical Directors, Clinical Scientists, and protocol authoring teams. Some who has done a lot of protocol writers and can also train other protocol writing in the pharma sector.. Strong medical writing and clinical project management experience, preferably in the biotech/Pharmaceutical industry. Bachelor's degree in the biological sciences or liberal arts preferred. Superb written and oral communication skills, with a proven ability to communicate effectively with all levels in the organization. storng experience writing protocols good stakeholder managemet skills

Business Change Consultant ( Pharma/Logistics ) Looking for a change agent that can help C suite stakeholders to deliver valued transformational change. End to end Project Manager/ Change Analyst/ Business Analyst hybrid would be ideal, as it is a small team and you would need to wear a number of hats. You will be managing both operation change and green field projects in the Pharma sector . A diverse role that captures tangible business change, any exposure to Healthcare, Supply Chain or Logistics projects would be advantageous, as would projects around Brexit, legislation and working across European landscapes. This is a wide ranging role and would suit a contractor who has worked across multiple sectors and companies Ideally you will have experience in Business Analyst and I really need someone who has excellent Visio skills . A self-starter who can work well alone and also as part of a team. The role is 80% homeworking but you must be able to travel to the Midlands once a week. Please apply today for more details

Vivid is currently working with a client of ours in the North West who is looking for some additional support in their IPC team. They are looking to recruitment someone ASAP to help full, or part time with community based IPC advice. Much of this advise will be around care homes, schools and organisations in the community setting. It may involve audits and training, depending on the fluid needs of the client at the time. The post will be for around 6 months and will likely end if and when they find someone on a fixed term contract basis. Would you be interested in hearing more? Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.

My local authority client based in Yorkshire is seeking a lead IPC nurse to help provide advice to schools, care homes and other community based functions 3-5 days per week. They require some onsite presence, but the majority of the work can be done from home. We are looking for; IPC qualified Nursing registration (will consider applications without if IPC knowledge is strong) Local authority or NHS experience The role will be for 6 months and is paying £250-350 per day via an umbrella depending on experience. If you're interested in knowing the specifics, please do give me a call. Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.

My client, a public sector organisation, is seeking a Project Manager for a transformation project within their Children, Schools and Families Recovery and Modernisation programme. This role will be inside IR35. Options to be modelled include: in- borough residential accommodation for looked after children semi-Independent accommodation for Looked after children aged 16 & 17 accommodation for care leavers aged 18+ who require additional support to live independently Model(s) taken forward will reduce reliance on spot purchasing and improve supported accommodation options and improve borough sufficiency for looked after children Dependent on outcome of the cost benefit analysis, options may also provide revenue generation opportunities through supply to local authority organisations and reduce infrastructure spend through shared costs for example; in partnership with a Local Authority . Savings target 21/22 £400,000 care leavers Estimated additional savings £540,000 (in- borough children's home accommodation including semi-independent living and on- site support accommodation for young adults with additional needs) What you will have the opportunity to do as a Project Manager: undertake independent cost benefit analyses of options to inform final decisions, including robust financial modelling of each option and potential of scaling opportunities (ie partnership approach, supply to other LAs) and in; alignment towider system accommodation opportunities cross departments and/or with partner organisations Ensure engagement of children and young people to help shape options; develop further detail to support the corporate approval of the department's preferred option(s) for residential accommodation and semi-independent accommodation including development of full business cases and high-level project plans to enable sign off and mobilisation of project; Skills and experience required as a Project Manager: Knowledge of statutory duties including responsibilities of corporate parent Strong understanding of current pressures within the sector (particularly residential care) Experience in leading a similar project with children's services Experience of working in fast paced and complex environments Successfully delivering an end to end piece of work within strict timescales Understanding of co-production with stakeholders Experience of undertaking Cost benefit analysis and options appraisals with strong financial modelling skills Project management skills Due to the high number of applicants that usually apply to a role with the title 'Project Manager', only those with relevant experience will be contacted.

In order to strengthen the development department in oncology, we are now searching for a clinical development director to lead defined program level activities (eg submission activities, briefing books etc.), and/or indication related assigned clinical trials. Major activities: Provides clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols or sub studies consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications Leads development of clinical sections of trial and program level regulatory documents (eg, Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities) Drives execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, if applicable Oversees/conducts ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead Supports review/writing documents related to safety of the molecule for the assigned Requirements: Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. - - PharmD, or PhD strongly preferred Preferred experience in benign or malignant hematology; or oncology strong experience in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. strong contribution to and accomplishment in all aspects of conducting clinical trials (eg, planning, executing, reporting and publishing) in a global/Matrix environment in pharmaceutical industry Advanced knowledge of assigned therapeutic area Demonstrated ability to establish strong scientific partnership with key stakeholders Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process People management experience preferred, this may include management in a Matrix environment. Global people management experience desirable Excellent communication skills, written and oral Strong interpersonal skills Excellent negotiation and conflict resolution skills Michael Bailey International is acting as an Employment Business in relation to this vacancy.

INDUSTRY: Pharmaceuticals DESCRIPTION: Our specialty Biopharmaceutical client currently has an exciting new opportunity for an experienced Medical Manager . This person will manage medical affairs and clinical research activities for the company's current and pipeline products. They will provide pharmacovigilance oversight for the products in Canada as well as interventional and non-interventional studies and guidance on pre-NOC access programs. REQUIREMENTS FOR THE Medical Manager - Candidates must have: Minimum 2 years of experience working in a pharmaceutical head office environment in a Medical Affairs or Medical Advisor role. Minimum 2 years Clinical research and trial management experience Solid understanding of pharmacovigilance activities Experience and solid working knowledge of the oncology therapeutic area Post Graduate Degree in Life Sciences ( PharmD or PhD) Superior communication skills and the ability to engage and collaborate with internal and external stakeholders We thank all interested applicants, but only those individuals meeting/exceeding the above requirements need apply. Since international travel to the USA and/or other countries may be required, valid documentation is necessary. To ensure your résumé is given priority, please include your current city/GTA region of residence.

Global pharmaceutical company has a new opening for a temporary support for experienced medical director to provide expertise for clinical development plans and strategy execution for successful completion of all activities related to project. Major Activities: 1) Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications 2) Leads development of clinical sections of trial and program level regulatory documents (eg, Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities) 3) Drives execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates if applicable 4) Oversees/conducts ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) 5) May be the Program Manager of other associates (eg., CSE). 6) May act as study medical monitor 7) Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety 8) Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH 9) As a medical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (eg, regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (eg, CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards 11) Ensures career development of Program reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, & mentoring support 12) Contributes to medical/scientific training of relevant stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training 13) May serve on or lead global initiatives (eg, process improvement, training, SOP development, other Clinical Development line function initiatives) IDEAL BACKGROUND: MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (eg, internal medicine or sub-specialty) required, with Medical Board certification preferred; Clinical practice experience = 4 years (including residency) preferred * experience in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. * Advanced knowledge of assigned therapeutic area * Demonstrated ability to establish strong scientific partnership with key stakeholders * Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process * People management experience preferred, this may include management in a Matrix environment. Global people management experience desirable * Excellent communication skills, written and oral * Strong interpersonal skills * Excellent negotiation and conflict resolution skills This is 100 % home based role for initial 5 months contract with possibility to extend further. Please send your CV Michael Bailey International is acting as an Employment Business in relation to this vacancy.