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    Data Visualisation Analyst/Power BI Developer (Contract) role for a Global Medical Device company.

    The Data Visualisation Analyst position will be responsible for building reports and dashboards to support the Financial and Commercial Reporting workstreams.

    Duration: 3 Months
    40 hours per week

    Rate: £45 – £60 p/h (dep. on experience)

    Location: Watford

    Key Responsibilities include:

    • Build new visualisations in Power BI to demonstrate business performance and uncover opportunities.
    • Create Power BI dashboards and reports regularly and perform quality checking to ensure accuracy.
    • Explain data, visualisations, their meaning and application to the technical and non-technical business users.
    • Engaging with the business and leadership on requirement definition.
    • Working with end users to create mockups and design documents.
    • Create and update design documents in Confluence.

    • Create visually appealing and interactive data visualisations that drive action within the business using Power BI.
    • Publish new dashboards and reports using Power BI.
    • Support the UAT process and conduct the initial round of testing.
    • Document new dashboards when they are created.
    • Work with IT to test and incorporate new data sources as they become available.
    Beyond the core responsibilities, it is expected that the candidate will be able to direct users in the essential operation of Power BI and assist and train users in the interpretation of visualisations.

    Would this be a role for your interest?

    If so, please contact me via

    Email: shakir.h.a4lgdx1gucb5@skillsalliance.aptrack.co
    Phone: 0207 220 6232

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    Provide medical guidance and leadership throughout the development and conduct of clinical trials.
    You will be responsible for overseeing development of the functional strategy, designing and/or managing the implementation of the clinical strategy within Clinical Development both regionally and globally.
    A. Quantitative aspects of the role

    • Manage global or regional therapeutic or research projects within the Oncology arena.
    • Act as an expert involved in the design, conduct, monitoring, data interpretation and reporting of individual clinical trials.
    • Additional responsibilities include compliance with adverse event reporting, and all pharmacovigilance (PVG) regulations and guidelines. You will ensure projects adhere to Good Clinical Practice and regulatory requirements.
    • Closely follow medical developments within assigned areas and disseminates new information within Clinical Development to transform trends and emerging data into new plans.
    • Liaise with the internal and external medical community to follow developments within areas of expertise.
    • Maintain a high degree of understanding and awareness on new and emerging medical development.
    • Follow important developments and trends in scientific literature and develops contacts with opinion leaders.
    • Lead regulatory communication and preparation of higher level documents.
    • Respect of milestones.

    B. Qualitative aspects of the role

    • Ensure the quality of given medical advice
    • Enforce scientific and medical quality of all clinical trial documents (including the Investigator’s Brochure and the CSR)
    • Interface with the Program Director & R&D Leaders (to ensure milestone realization and resource optimization)
    • Increase the recognition of the company and the products within the scientific and medical communities

    C. Global Responsibilities
    1. Lead Clinical Development activities for a series of studies

    • Interface with the clinical team to develop clear clinical trial strategies, design study protocols, monitor, document, and interpret clinical study data
    • Provide medical support to clinical operations team.
    • Implement safety strategy across studies, including regular review of safety data and response to safety issues including communications with investigators and regulatory agencies
    • Review AEs, SAEs, lab data, tables, listings, & graphs; provide medical assessment and instruct staff in appropriate query and follow up activities
    • Perform medical assessment for expedited reporting, IND & EU annual reports, FDA Periodic Reports, and Periodic Safety Update Reports, SUSAR reporting, etc.
    • Lead medical sections of regulatory documents in EU and US ; assist team with preparations for regulatory agency meetings and reports, including patient and safety narratives.
    • Assure medical consistency within trial and across trials.
    • Provide guidance to biometrics staff on data collection, statistical analysis planning, and blinded/unblinded TFL review

    2. Serves as scientific reference for the franchise (internally/externally)

    • Represent the company in meetings with health authorities and the scientific community, net-work with thought leaders and international agencies as needed
    • Publish clinical data in peer review journals and present in external scientific meetings/congresses
    • Responsible for follow-up of project related literature
    • Manage Key Opinion Leaders
    • Contribute to the clinical components of “Due Diligence” and other clinical activities in support of Business Development
    • Provide medical support to Marketing in order to achieve Company’s objectives
    • Manage Clinical Steering Committee and Advisory Boards
    • Provide performance feedback on matrix team members to responsible line managers
    • Travel up to 50% of his/her time

    Time repartition:
    • 10% – Strategy
    • 30% – Leadership
    • 40% – Operations management
    • 20% – External relationship

    Travel: 30% (max)

    The successful candidate will report into the VP Head Global Clinical Development and Medical Affairs located in Belgium.

  • Project Management

    €70000 - €205000 per annum
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    SURGERY – INNOVATION – SALES

    Our client – leading innovative medical company – is considering the candidates to be a Territory Sales Manager.

    Tasks: managing a capital equipment sales process + maintaining relationship with surgeons, KOLs and C-Level representatives.

    • Leadership: you would not need to manage people or team, but a complex and exciting sales process
    • Area: BeNeLux (negotiable)
    • Travel: up to 50% (depends on account distribution)
    • Company: an obvious leader in its field in Medical Devices (this job is an additional role due to the company`s growth)
    • Compensation: a quite competitive package and good prospective.

    You offer:

    • Bachelor`s degree or equivalent
    • OR experience (general surgery, urology, gynaecology etc.)
    • Minimum 5 years sales experience in Healthcare (ideally in Medical device field)
    • Capital equipment sales is a great plus

    Are you interested?

    Please reach out to Maria Nosach T: 0041 43 508 69 62

  • Project Management

    €70000 - €205000 per annum
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    Job
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    SURGERY – INNOVATION – SALES

    Our client – leading innovative medical company – is considering the candidates to be a Territory Sales Manager.

    Tasks: managing a capital equipment sales process + maintaining relationship with surgeons, KOLs and C-Level representatives.

    • Leadership: you would not need to manage people or team, but a complex and exciting sales process
    • Area: BeNeLux (negotiable)
    • Travel: up to 50% (depends on account distribution)
    • Company: an obvious leader in its field in Medical Devices (this job is an additional role due to the company`s growth)
    • Compensation: a quite competitive package and good prospective.

    You offer:

    • Bachelor`s degree or equivalent
    • OR experience (general surgery, urology, gynaecology etc.)
    • Minimum 5 years sales experience in Healthcare (ideally in Medical device field)
    • Capital equipment sales is a great plus

    Are you interested?

    Please reach out to Maria Nosach T: 0041 43 508 69 62

  • Project Management

    €70000 - €205000 per annum
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    SURGERY – INNOVATION – SALES

    Our client – leading innovative medical company – is considering the candidates to be a Territory Sales Manager.

    Tasks: managing a capital equipment sales process + maintaining relationship with surgeons, KOLs and C-Level representatives.

    • Leadership: you would not need to manage people or team, but a complex and exciting sales process
    • Area: BeNeLux (negotiable)
    • Travel: up to 50% (depends on account distribution)
    • Company: an obvious leader in its field in Medical Devices (this job is an additional role due to the company`s growth)
    • Compensation: a quite competitive package and good prospective.

    You offer:

    • Bachelor`s degree or equivalent
    • OR experience (general surgery, urology, gynaecology etc.)
    • Minimum 5 years sales experience in Healthcare (ideally in Medical device field)
    • Capital equipment sales is a great plus

    Are you interested?

    Please reach out to Maria Nosach T: 0041 43 508 69 62

  • Apply

    Job
    Application

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    I am currently working with a Global Medical Device Manufacturer who are looking for an MDR Regulatory Affairs Specialist.

    Contract length: 12-months
    Location: Hull
    Hours: 37.5
    Rate: £35 – £40 per hour (depeding on experience)

    My client is looking for someone with 3 years’ experience within Regulatory Affairs and an understanding of the EU MDR.

    I have outlined the JD below:
    · To compile, review and approve, as required, regulatory despatches in accordance with national requirements to ensure appropriateness and consistency in consistency in content and presentation of information both within and between registration applications. Particular focus upon the new European Medical Device Regulation (MDR).

    · To complete the requirements of the Registration Programme as agreed with the AWM and Operations departments.

    · To provide on-going regulatory advice to project teams throughout product and process development to ensure regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives.

    · To liaise with external regulatory authorities to ensure approvals are obtained in line with the launch plan.

    · To review and approve artwork, labelling and promotional literature and advise on its acceptability/compliance with regulations and registered details.

    · To review and approve change control impact assessments for products.

    · To approve European Technical Files and regulatory despatches, where appropriate.

    · Deputise for the Regulatory Affairs Managers when required.

    · Ensure compliance to cGMP, cGDP, ISO 13485, US FDA 21 CFR Part 820 and any other applicable quality standards or regulations concerning Medicinal Products and Medical Devices.

    Please let me know if this would be of interest for you?

    Please contact Shakir Hossain at Skills Alliance

    Phone: +44 207 220 6232

  • Apply

    Job
    Application

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    Share

    Data Visualisation Analyst/Power BI Developer (Contract) role for a Global Medical Device company.

    The Data Visualisation Analyst position will be responsible for building reports and dashboards to support the Financial and Commercial Reporting workstreams.

    Duration: 3 Months

    40 hours per week

    Rate: £45 – £60 p/h (dep. on experience)

    Location: Watford

    Key Responsibilities include:

    • Build new visualisations in Power BI to demonstrate business performance and uncover opportunities.
    • Create Power BI dashboards and reports regularly and perform quality checking to ensure accuracy.
    • Explain data, visualisations, their meaning and application to the technical and non-technical business users.
    • Create and update design documents in Confluence.

    • Create visually appealing and interactive data visualisations that drive action within the business using Power BI.
    • Publish new dashboards and reports using Power BI.
    • Support the UAT process and conduct the initial round of testing.
    • Document new dashboards when they are created.
    • Work with IT to test and incorporate new data sources as they become available.

    Would this be a role for your interest?

    If so, please contact me via

    Email: shakir.h.a4lgdx1gugqu@skillsalliance.aptrack.co
    Phone: 0207 220 6232

  • Project Management

    €40 - €70 per hour, Benefits: Ideal Office Location
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    I am working with a high profile Clinical Research Orgnisation that is looking for an expeiranced CRA to join the team on a freelance basis, Ideally with experiance in Pharma and CRO’s. This is a client who has a great reputation and one that value all workers

    In summary

    Ensures that Investigators are conducting clinical trials in accordance with international Regulatory and Ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonization (ICH).

    Responsibilities

    • Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and SOPs for monitoring requirements.
    • Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
    • Tracks and supervises collection of ongoing study data for purpose of regular project status reporting.
    • Collects and reviews regulatory documents as required.
    • Prepares site visit reports and telephone contact reports.
    • May participate in the start-up process including reviewing protocols, reviewing CRFs, preparing Informed Consent forms, developing study documents, and organizing and presenting at investigator meetings.
    • Resolves site issues, including site recruitment challenges, and determines status for IP shipment.
    • Assists the Project Manager (PM), Clinical Team Leader and/or Lead CRA (CTL/LCRA) with generation of study specific forms for completion by CRA and Investigators and follow up with the teams to ensure timely completion and submission.
    • Works with PM/CTL/LCRA to secure authorization of site contracts.
    • Informs team members of completion of regulatory and contractual documents for individual sites.
    • Attends Investigator Meetings (IM) and study specific training meetings.
    • May translate, coordinate translations or review completed translations of critical documents.
    • Participates in feasibility and/or site identification activities. Contacts local opinion leaders, medical consultants or specified investigators and identifies sites with the potential for participation. Follows the feasibility procedures for documentation of feasibilities performed.
    • Identifies the documentation required for review by Regulatory Authorities and Ethical Committees. Prepare Regulatory and Ethics Committee submissions. Ensure written approvals are obtained and distributed appropriately prior to Site Initiation.
    • Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required.
    • Conducts Assessment and/or Training Visits of CRA I/II as required.
    • Assists the Project Team with the day-to-day management of critical studies as required, including attendance at team meetings.
    • Organizes processes for interim and final payments to Investigators, including preliminary calculations, review and approval from Project Management, logging trial expenditure, receipts, invoices and income.
    • Provides secondary in-house review of CRFs (if required).
    • Must work both independently and in a team environment.

    Working Relationship

    • Reports directly to Clinical Team Leader, Clinical Research Manager or Clinical Operations Manager.
    • Liaises with Investigators, Site Staff, Regulatory Authorities and Ethics Committees.
    • Liaises with Sponsor scientific and medical personnel.
    • Liaises with Vendors and Sub-contractors such as Central Laboratory and Courier organizations.
    • Liaises with Quality Assurance personnel.

    Qualifications

    • At least three years clinical monitoring experience and/or relevant clinical trial experience.
    • Relevant life science degree / medical / nursing background or equivalent.
    • Customer service orientation.
    • Sound knowledge of medical terminology and clinical monitoring process.
    • Attention to detail.
    • In-depth therapeutic and protocol knowledge as provided in previous or company provided training.
    • Excellent communication in Italian and English in both written and verbal skills.
    • Computer literate and proficient in Microsoft Office.
    • Excellent interpersonal and organizational skills.
    • Demonstrated ability to work independently and to effectively prioritize tasks.
    • Demonstrated ability to manage multiple projects.
    • Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and clients.
    • Demonstrated ability to develop, organize and manage new skills and tasks and mentor colleagues.

    If this is sounds like a role you are intrested in please do contact me by email on jack.sinclair(@)skillsalliance.com or by phone on +44 (0) 2072206235

    I look forward to speaking with you.

  • Project Management

    €90 - €150 per hour
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    I am currently working with an Innovative US-based Medical Device who are looking for an MDR Regulatory Affairs Specialist.

    The company itself is experiencing a large-amount of growth as they are looking to expand into the European Market.

    Contract length: 6-12 months

    Rate: €90 – €150 (dependant on experience)

    Location: Baden-Württemberg

    Hours: 1 FTE

    My client is looking for someone with UDI experience within Regulatory Affairs and an understanding of the EU MDR.

    I have outlined the JD below:

    • To compile, review and approve, Clinical Evaluation, Post Market Surveillance, Risk Management Reports in accordance with the new European Medical Device Regulation (MDR).
    • To provide on-going regulatory advice to project teams throughout product and process development to ensure regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives.
    • To liaise with external regulatory authorities to ensure approvals are obtained in line with the launch plan.
    • To review and approve change control impact assessments for products.
    • To approve European Technical Files and regulatory despatches, where appropriate.
    • Ensure compliance to ISO 13485, US FDA 21 CFR Part 820 and any other applicable quality standards or regulations concerning Medicinal Products and Medical Devices.

    Please let me know if this would be of interest for you?

    You can contact me via:

    Email: shakir.hossain (at) skillsalliance.com

    DDI: +44 (0) 207 220 6232

  • Project Management

    €60 - €85 per hour, Benefits: Working from home
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    Share

    About the Role
    My client are seeking a experienced and dedicated Clinical Research consultant to support our Clinical Trial Coordination group. Committed to supporting high quality Phase 3 trial. You will be in charge of managing and delivering a large phase 3 trial. Also providing your experitise to other parts of the bussiness.

    Responsibilities

    Department Management

    • Oversight of Clinical Coordination processes and activities, ensuring quality and compliance
    • Proactively identify process improvement/change initiatives; work with stakeholders to implement effective change
    • Write SOPs/guidelines/templates; approve guidelines/templates developed by others
    • Develop and deliver training
    • Key contact for Clin Ops and other functional leads in relation to clinical trial activities (resourcing, scheduling, conduct)
    • Key contributor to internal audit activities
    • Manage departmental contribution to regulatory inspection readiness and conduct
    • Key stakeholder for designated electronic system implementation.
    • In consultation with Associate Director, drive resource planning, staff recruitment and project allocation/workload management.

    Trial Coordination and Management

    • Work in close collaboration within the senior team to coordinate the set-up, maintenance, and close out of assigned clinical trials and programs, conducted by my client and/or CRO clinical project teams
    • Set-up of study vendors/CROs and contributes to vendor/CRO oversight activities
    • Primary contact for specific activities (as delegated)
    • Contribute to, maintain and distribute project plans, essential documents and other project documentation
    • Create and distribute metrics reports as required to internal and external stakeholders
    • Monitor trial metrics for compliance with project plans, quality standards and procedures.
    • Proactively identify potential trial issues/risks as a contributor to, and administers, the Risk Management Plan. Recommend/implement solutions, ensuring appropriate consultation/escalation
    • In conjunction with the CPM, develop the trial-specific TMF Plan
    • Create and maintain TMF; contribute to oversight of CRO-managed TMF
    • Coordinate TMF review activities; conduct assigned TMF review
    • May take responsibility for completing any task assigned to Clinical Projects Assistants (CPAs) in SOPs and Guidelines.

    Requirements

    • Educated to secondary level education
    • Strong previous experience in clinical trial administration, including TMF management
    • Line management or supervisory experience
    • Excellent attention to detail
    • Able to work both collaboratively and independently
    • Good interpersonal skills – including oral and written communication skills
    • Strong time and project management skills

    If this sounds like a role that you are intrested in I would be keen to speak with you on the phone, my number is: +44 (0)2072206235 or by email: jack.sinclair(@)skillsalliance.com (Bracket not included)

  • Project Management

    £450 - £600 per day
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    Job
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    Share

    I am currently working with a mid-sized biotech company specialising in cancer treatment for patients.

    My client is looking for a Regulatory Manager for a 12-month period.

    Contract: 12-months

    Rate: £450 – £600 per day (dependent on experience)

    Hours: Full-time

    Location: London

    I have outlined the job description below:

    • The role has a focus on the management of all maintenance activities for open CTAs in Europe
    • This person will manage any new CTA applications for the EU that may come up during the duration of the contract
    • Experience in Oncology and with biologics

    Please let me know if this would be of interest for you?

    Contact me:

    shakir.hossain (at) skillsalliance.com

    +44 (0) 207 220 6232