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  • Posted: Aug 3, 2022
    Deadline: Not specified
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    Sharing a Vision to Drive Healthcare Forward Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources. We are inspired by the potential ...
    Read more about this company

     

    Informed Consent Form Lead

    RESPONSIBILITIES

    • Under general supervision, perform site activation activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.
    • Prepare site regulatory documents, reviewing for completeness and accuracy.
    • Inform team members of completion of regulatory and contractual documents for individual sites.
    • Distribute completed documents to sites and internal project team members.
    • Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
    • Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.

    MINIMUM REQUIRED EDUCATION AND EXPERIENCE

    • High School Diploma or equivalent, with 3 years’ experience in an administrative environment or equivalent combination of education, training and experience.
    • Fluency in English.
    • Good interpersonal communication and organizational skills.
    • Good computer skills and knowledge of MS Office applications.
    • Good attention to detail.
    • General awareness of clinical trial environment and drug development process.
    • Ability to work on multiple projects.
    • Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.

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    Statistical Programmer 2

    Job Overview:

    As a Statistical Programmer 2, you will provide advanced technical expertise to develop and maintain programs to meet internal and external clients’ needs.

    You will plan and lead the development of project-related solutions to the full scope of statistical programming tasks.

    As a lead programmer on assigned studies, you will write and maintain programming specifications datasets and program TLFs, to maximize programming efficiency with the use of biostatistical tools and assist in training and mentoring new or junior team members

    PLEASE ONLY APPLY IF YOU MATCH OR EXCEED THE CANDIDATE REQUIREMENTS BELOW. PLEASE SUBMIT YOUR CV IN ENGLISH

    Essential Candidate Requirements:

    • Bachelors or Masters’ in Computer Science, Mathematics or equivalent
    • 3+ years, statistical programming experience within the Life Science industry in SAS
    • Experience as project lead, directly engaging clients and coordinating tasks within a programming team
    • Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
    • Knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
    • Ability to independently lead multiple tasks and projects

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    Regulatory & Start-Up Specialist

    Job Overview
    Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

    Essential Functions

    • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
    • Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
    • Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
    • Distribute completed documents to sites and internal project team members.
    • Prepare site regulatory documents, reviewing for completeness and accuracy.
    • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
    • Review and provide feedback to management on site performance metrics.
    • Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
    • Inform team members of completion of regulatory and contractual documents for individual sites.
    • Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
    • Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
    • Perform quality control of documents provided by sites.
    • May have direct contact with sponsors on specific initiatives.

    Required Qualifications and Skills

    • B Sc degree and 2 years' clinical research / regulatory / contracts experience
    • Good interpersonal communication and organizational skills.
    • Good knowledge of MS Office applications.
    • Good attention to detail.
    • General awareness of clinical trial environment and drug development process.
    • Ability to work on multiple projects.

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    Clinical Trial Manager

    Responsibilities of this role include:

    • Working closely with the Project Manager to define programme targets for clinical monitoring staff and ensure work is documented within the contracted project scope.
    • Development and implementation of Clinical Monitoring Plan.
    • Responsibility for ensuring the needs of the clinical sites are met by facilitating the monitoring processes
    • Coordination and oversight of daily operations of the clinical monitoring team.
    • Management of  project milestones and proactively address deficiencies
    • Management of CRA performance

    Requirements

    • BSc degree or equivalent in Life Sciences/Nursing
    • Prior experience as trial/study manager or strong background as Lead CRA
    • Thorough knowledge of clinical research process
    • Prior experience as Clinical Research Associate
    • Strong communication skills
    • Fluency in spoken and written English
    • Excellent organisation and interpersonal skills
    • Ability to manage multiple priorities
    • Understanding of basic data processing functions, including electronic data capture
    • Ability to work independently, prioritise and work within a matrix team environment

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    Business Developmet Specialist

    Essential Functions

    • Achieves and/or exceeds monthly sales targets by collaborating with field sales representatives. Enhance the sales process by analysing a wide range new customer pipelines and prospecting new customers.
    • Collaboratively works with multiple field sales representatives to develop an overall customer account plan to maximize opportunities and generate sales activity.
    • Identifies, qualifies and capitalizes on new sales opportunities by pulling information from various resources to interpret prospective customers’ needs to make informed decisions and recommendations to management for sales targeting.
    • Proactively coordinate the lead identification and qualification process through the sales cycle.
    • Grows and maintains multiple existing customer and partner relationships as well as identifies new customers through proactive call planning and execution.
    • Engages with customers and target audience by telephone/email and hosting internet based “on-line” meetings.
    • Participates in strategy calls and bid defences as needed.
    • Participates in joint calls in the field with appropriate field sales representative as needed.
    • Communicates directly with sales management and sales colleagues to ensure consistency of approach and standardized outputs to clearly communicate sales performance and internal and external customer related information.
    • Contributes to the development of tailored communication materials (e.g. Proactive proposals, related marketing materials) used to further develop client relationships.
    • Maximizes sales by effectively utilizing sales and marketing materials, appropriate databases and technologies.
    • Maintains records in the required reporting systems (e.g. CRM – SalesForce.com); report daily calls and produce reports in an accurate and timely manner.
    • Keeps Manager informed about changes in pipelines, competitor activities and other market changes.
    • Maintains up to date sales/technical knowledge of any relevant specialty and disease area(s), as required.
    • Executes against leads, tasks and assignments from all sources targets and record these activities in CRM.
    • Handles inbound/outbound calls to and from interested healthcare professionals and triage when required.

    Qualifications

    • Bachelor's Degree and related experience; or equivalent combination of education, training and experience.
    • Demonstrable B2B sales experience
    • Knowledge of Life Science or Pharma Market and drug development life cycle - preferred
    • Possess strong organisational skills and attention to detail.
    • Possess strong communication skills, both verbal and written.
    • Ability to organize and prioritize own work.
    • Ability to establish and maintain effective working relationships internally and across multiple field sales organizations
    • Possess advanced computer skills (MS Office Suite: MS Excel, MS Word, MS PowerPoint, MS Access, MS Outlook, and Internet).
    • Maintain focus and commitment on assigned targets.
    • Ability to analyse and interpret data from a variety of sources and systems.
    • An attitude which is positive, energetic, flexible and supportive in a challenging environment.
    • Ability to speak additional European language - beneficial

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    Associate Director Strategic Pricing

    JOB DESCRIPTION
    This is an career opportunity for an experienced Pricing specialist to join our Global Pricing team at strategic level. The role will lead the day to day activities of Strategic Pricing for the overall enterprise. It will be collaborating with customers and internal
    stakeholders to create and implement pricing/delivery strategies and tools to support sales, revenue and profit growth. This is an essential role to our profitability. This is a homebased role, which could be based out of any European country.

    Essential Functions

    • Provides integrated pricing support and vision across functions and therapeutic delivery units in support of customers and the Clinical Development business line.
    • Works with internal customers to translate operational strategies into cost-competitive solutions that align with customer needs.
    • Works with internal and external customers to create and implement traditional and non-traditional pricing/delivery alternatives, tactics and methodologies to meet customer needs.
    • Contributes to the development, implementation and maintenance of our pricing tools.
    • Contributes to discussions on business pricing/delivery strategy and direction and ensures a consistent application of our strategies across all opportunities.
    • Negotiates financial and business terms for contracts involving traditional and non-traditional pricing models.
    • Fully supports the management team to ensure all team goals and objectives are met.
    • Perform other duties as assigned

    Qualifications

    • Degree in Business, Marketing or other directly related
    • A minimum of 7 years of experience in Business Management, Contracts Management, Finance and or CRO industry, with up to 5 years direct pricing experience.
    • equivalent combination of education, training and experience.
    • Knowledge of pricing, finance, operations, contract negotiations and CRO industry.
    • Strategic business and Industry awareness.
    • Strong analytical skills and experience in evaluating business plans.
    • Excellent attention to detail and ability to work simultaneously on multiple priorities.
    • Experience and ability to help coach and mentor staff and supported teams.
    • Ability to design and implement pricing, delivery and budgeting strategies to drive growth for a large global organization.
    • Excel and financial analysis skills sufficient to support analysis and development of delivery strategies and budgets, pricing methodologies and systems.
    • Ability to establish and maintain effective working relationships with coworkers, managers and customers.

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    (Senior) Patient Recruitment Specialist

    RESPONSIBILITIES

    • Assist Management and Patient Recruitment Operation Leads in completion of the scope of work, objectives, quality of deliverables, and other activities of projects as deemed necessary
    • Assist in coordination of project activities for team members regarding their project-oriented tasks to ensure that project milestones are met
    • Assist in tracking resources to assure adequate coverage to meet project deliverables and milestones 
    • Provide technical support as necessary on project specific and interdepartmental training effort
    • Assist with the establishment of new procedures and offer suggestions for process improvements for existing procedures.
    • Communicate with sites regarding Recruitment and Retention activities, including but not limited to; making follow-up calls regarding patient referrals, tracking logs, translations management, management of eSIFs and ICFs, finance trackers, receipt of Recruitment and Retention materials, etc.
    • May represent Patient Recruitment with sites on the conduct of centralized Recruitment and Retention efforts (e.g. follow up with sites for missing documents, answer site questions, conduct Recruitment and Retention teleconferences with sites, etc.)
    • Update, manage and maintain data tracking entries into designated tracking systems and tools in accordance with project requirements 
    • Assist Managers with periodic report generation and review
    • Assist with the onboarding and training of new staff by acting as a role mentor and provide role shadowing opportunities as needed 
    • Other duties as assigned by Management

    REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

    • General awareness of the clinical trial environment and drug development process 
    • Good word processing skills and knowledge of MS Office applications 
    • Good attention to detail 
    • Ability to work on multiple projects 
    • Strong interpersonal skills and effective presentation skills 
    • Ability to establish and maintain effective working relationships with coworkers, managers and clients
    • Computer skills including proficiency in aspects of data analysis and presentation software, Microsoft Word, and Excel
    • Good written and verbal communication skills including good command of English
    • Ability to work creatively and independently in a complex global environment. Ability to adapt and be flexible to changing priorities
    • Knowledge of the digital development process as well as the creative studio process for all deliverables is preferred
    • Experience with workflow management systems preferred 
    • Bachelor’s Degree with experience in an administrative environment or equivalent combination of education, training and experience

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    Senior Consultant: MC

    Essential Functions

    • Participates or leads teams in the design, development and delivery of consulting projects or components of larger, complex projects.
    • Reviews and analyzes client requirements or problems and assists in the development of proposals of cost effective solutions that ensure profitability and high client satisfaction.
    • Provides direction and guidance to Analysts, Consultants, and where relevant, to Statistical Services assigned to engagement.
    • Develops detailed documentation and specifications.
    • Performs qualitative and/or quantitative analyses to assist in the identification of client issues and the development of client specific solutions.
    • Designs, structures and delivers client reports and presentations that are appropriate to the characteristics or needs of the audience.
    • May deliver some findings to clients.
    • Recommends improvements and alternative solutions to resolve problems.
    • May identify new business opportunities of follow-on work and new leads at assigned client.
    • Provides follow-up with client after project deliverable has been completed to ensure client satisfaction.
    • Proactively develops broader and deeper knowledge of related consulting methodologies and life sciences market through on the job experience and participation in training opportunities. Begins to develop CoE specific subject matter expertise.
    • When acting as Project Manager, proactively manages project timelines and manages day to day communication with the client and team members.

    Qualifications

    • Bachelor's Degree in Economics, Business Administration or any related field.
    • Master's Degree in Business Administration Preferable.
    • Minimum 5-8 years of related experience in consulting and/or life sciences industry.
    • Possesses solid project management skills and client influencing and relationship building skills.
    • Works willingly and effectively with others in and across the organization to accomplish team goals.
    • Experienced with developing consultative relationships with senior level managers and executives at clients in the life science industry.
    • Ability to manage multiple projects, juggle priorities and deliver on tight deadlines.
    • Knowledge of consulting methodologies, tools and techniques related to functional area.
    • Knowledge of key issues and current developments in the life science industry.
    • Excellent presentation, communication and client influencing skills.
    • Has established network and referral contacts.
    • Has necessary subject matter expertise to effectively manage projects within a given CoE.

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    Lab Project Svcs Lead

    Essential Functions

    • Establish a close working relationship with all PC/SS team members, OCL (Operational Client Lead) and CLM (Client Liaison Manager) representatives (where applicable) to ensure consistent quality and global delivery of all studies, which may include sponsor-specific standards and programme-specific procedures. Collaborate with other functional groups within the company, where necessary, in order to ensure PC/SS colleagues are able to deliver in relation to study milestones. Provide support for study-specific challenges and help to negotiate obstacles. Support the Project Services department as required within the chosen subject matter expert (SME) field, coaching less experienced employees in processes and task completion. These fields should include, but not be limited to:
    • Training
    • Processes
    • Resourcing
    • Systems . Serve as a liaison between PC/SS staff and the team manager. Provide day to day guidance of a more junior, or less experienced . Support initiatives and general coaching, with a focus on pre-launch and post-launch activities (where applicable). . May act as a highly experienced Project Coordinator/Set-up Specialist with a focus on supporting more complex studies or those with high visibility (rescue/escalation studies, study programmes or new clients for example). May also be responsible for managing own studies as required. . Support the project teams with investigations and preventive/corrective actions for reported incidents. . Direct, mentor and assist in training of less experienced Project Services staff. Report on team performance against job specific responsibilities, customer expectations, and project baselines in relation to the monitoring and overall project support required to be provided by the PC/SS. This will include 1:1 group meetings, coordination of resourcing requirements and acting as a point of escalation for team members to optimise client delivery. . Assist in the preparation of training needs analysis for staff, in collaboration with Departmental Trainers & L&D, and ensure that training is conducted as appropriate. . May perform duties and responsibilities of Project or Set-Up Coordinator or indeed Project or Set-Up Manager when needed, for short-term and long-term assignments. Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice. Work with other Lead PC/SS colleagues across all Q2 Solutions Project Services locations, supporting and participating within regional and global Lead PC/SS meetings. Support line manager with any other delegated actions required to support the PC/SS group and department overall.

    Qualifications

    • Bachelor's Degree Sciences or related field Pref Or
    • Other Equivalent combination of education, training and experience may be accepted in lieu of degree.
    • 2+ years of clinical or research industry experience, including 1 year project management / project set up experience Pref
    • Equivalent combination of education, training and experience
    • Possess strong interpersonal skills for interaction with senior members within sponsor organizations and demonstrated ability to meet deadlines.
    • Demonstrated computer proficiency with Microsoft Office and Quintiles LIMS system
    • Possess an understanding of medical and clinical research terminology
    • Demonstrated ability to work in a fast-paced, high demand environment
    • Previous knowledge of Q2 Solutions processes and computer systems is highly desired
    • Knowledge of Project Management processes and terminology
    • Good organizational and operational skills
    • Good accuracy and attention to detail skills.
    • Strong written and verbal communication skills including good command of English language.
    • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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    Applications Devl Spec 2

    JOB DESCRIPTION

    C# Developer Responsibilities:

    • Developing C# .NET solutions for the organization.
    • Creating in-house applications using the .NET framework, including MVC, Razor Pages.
    • Creating client facing mobile applications with the .NET Xamarin framework.
    • Publish regular updates to the App and Play Stores.
    • Creating and consuming in-house and client facing REST APIs.
    • Design and maintain Entity Framework ORM code (with backend SQL knowledge).
    • Debugging and maintaining written code.
    • Defining and organizing projects on an ongoing basis.
    • Reporting and resolving issues related to .NET projects.
    • Identifying and handling technical risks and issues.
    • Working in a project team alongside other developers using the git workflow.
    • Providing technical support to stakeholders in the organization.
    • Reporting on project statuses and developments to senior team members.
    • Participating in project meetings with management and other team members.

    C# Developer Requirements:

    • A bachelor's degree in computer programming, computer science, or information technology.
    • C#, .NET 5 (or higher), and Microsoft Visual Studio certification and experience.
    • A minimum of 5 years of experience as a C# programmer or developer.
    • Knowledge of other coding-languages (PHP, C+, Java, etc).
    • Ability to write clean, easy to understand code.
    • Outstanding analytical and problem-solving capabilities.
    • Excellent written and verbal communication skills.
    • Ability to work independently and complete projects with minimal supervision.
    • Sound understanding of coding and development processes.
    • Experience with working in an agile environment.

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    Senior Project Leader, Gastroenterology, Immunology and Women’s Health - Global Project Leadership

    JOB DESCRIPTION

    IQVIA’s Gastroenterology, Immunology and Women’s Health Unit is a global team of professionals dedicated to assisting our clients in driving healthcare forward and enabling medical breakthroughs that advance healthcare and patient treatment options around the world.  We are looking for a Senior Project Leader with experience in Gastroenterology, Autoimmune and Rheumatology, Dermatology, Rare Diseases, Plasma Derived Therapies or Women’s Health experience to join our innovative and dynamic group.

    As Senior Project Leader you will manage cross functional teams and liaise directly between IQVIA functions and the customer, acting as that accountable point for delivery and quality whilst maintaining financial control. You will be supported by domain experts in every function, enabled by best-in-class technology and data analytics.

    Key collaborators are the Clinical Lead for site management, the Project Vendor Manager, the Project Management Analyst for project coordination, tracking and financial analysis, and the Site Activation Manager as an expert in start-up.

    This is an important and high-profile role within our Research & Development Operation and IQVIA’s size and global footprint will present you with the breadth of opportunities necessary to develop your career.

    Typically assigned to one or two projects, or a program, responsibilities might include:

    • Leading global cross-functional project team delivery, accountable for achievement of milestones and quality of contracted scope
    • Serving as the primary contact with the customer for progress and governance
    • Developing study management plans and ensuring consistent use of study tools, training materials and compliance with standard processes, policies and procedures
    • Anticipating risk and implementing mitigation strategies
    • Managing study team assignments, accountability and resource requirements
    • Ensuring the study budget is managed proactively including scope changes and financial systems are accurate

    REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

    • Bachelor's degree in life sciences or related field
    • Global project management experience within the drug development industry, with previous CRO experience is ideal
    • Minimum 4 years prior project management experience and experience in clinical operations; or equivalent combination of education, training and experience
    • In depth therapeutic knowledge in Gastroenterology (Irritable Bowel Disease, Pancreatitis, Ulcerative Colitis, Crohn’s Disease, Non-alcoholic steatohepatitis (NASH), Gastroesophageal Reflux Disease (GERD)), Autoimmune/Rheumatology (RA, Lupus or Osteoarthritis), Dermatology (Psoriasis, Atopic Dermatitis or Urticaria) ), Rare Diseases Plasma Derived Therapies, or Women’s Health (including Fertility; Contraception; Endometriosis, Osteoporosis) would be an advantage

    Method of Application

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