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  • Posted: Apr 26, 2022
    Deadline: Not specified
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  • As the drug development business of Laboratory Corporation of America Holdings (Labcorp) and the world’s most comprehensive drug development #CRO service company, we have helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today. Because of our broad experience and specialized expertise, we&rs...
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    Principal Clinical Data Manager - Late Phase

    Description

    • You will be permanently employed by Labcorp Drug Development working in our Clinical Development Services (CDS) division working across multiple Sponsors and multiple therapeutic areas in Phases IIb to IV.
    • Office based or home based anywhere in Europe or South Africa.
    • You must have previous experience of working in a lead clinical data management role within clinical research.
    • Candidates must be fluent in English language (both verbal and written).

    Join our growing team and discover your extraordinary potential by working as a Principal Clinical Data Manager within our Global Clinical Development department. You will act as the SME for DM activities in relationship meetings with Sponsors, working directly with them and lead the implementation of their requirements.

    As Principal Clinical Data Manager, you will work alongside the leadership team to provide guidance, mentoring and training to the DM team. You will lead multiple studies and take responsibility for the development of project documentation, system set up, data entry & validation.

    You will be a key member of the DM team, joining bid defenses, capabilities presentations and other client engagements regarding budget, scope or DM processes.

    Other Duties Will Include

    • Lead a variety of complexed studies, including healthy volunteer and patient populations, multi-site, involving complex protocol design.
    • Be accountable for all DM deliverables, as assigned per timeline, providing instruction to their DM study team and reviewing completed work.
    • Ensure all projects are completed according to relevant protocols, SOPs and GCP standards.
    • Work with Project Managers to build timelines to meet contracted milestones via communication with other Data Managers and during study initiation meetings.
    • DM project leadership and accountability, lead DM internal meetings, meet frequently with study leads of EDC Design, SAS Programming, Stats & PK to ensure all deliverables are planned and coordinated.
    • Identify risks/mitigations, effectively communicates to ensure database lock dates are achieved.
    • Develop and maintain client relationships, drive process improvements and team training.
    • Support Managers with regards to performance evaluation of other team members, aid their career development.
    • Support budget development process for DM opportunities.

    Education

    • University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
    • Additional relevant work experience will be considered in lieu of formal qualifications.

    Experience

    • Extensive work experience in data management, including direct sponsor management and technical mentoring experience.
    • Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives to encourage team members to seek solutions.
    • Demonstrated skill for technical management of staff.
    • Financial management of gross revenues in excess of $250K per year.
    • In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
    • Experience representing DM in bid defense meetings, providing innovative solutions.
    • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
    • Ability to lead teams by example on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
    • Demonstrated managerial and interpersonal skills.

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    Sr Clinical Research Associate

    Responsibilities include:

    • All details of site management as prescribed in the project plans
    • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
    • Negotiation of study budgets with potential investigators and cooperation with Labcorp Drug Development legal department with statements of agreements
    • Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
    • Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Labcorp Drug Development or client data management systems

    Experience:

    • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
    • Excellent understanding of Serious Adverse Event (SAE) reporting
    • Ability to resolve project-related problems and prioritize workload for self and team
    • You have previous clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).

    go to method of application »

    Senior Statistical Programmer (FSP)

    Job Primary Functions

    • Perform the role of the Lead Statistical Programmer.
    • Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
    • Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
    • Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
    • Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Covance and Client standards
    • Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective
    • Mentor less-experience programmers in the processes around SDTMs, ADaMs and TFLs ensuring adherence to department practices and processes
    • Present and share knowledge at department meetings
    • Respond to QA and client audits and support qualification audits
    • Contribute to proposal activities and participate in bid defenses meetings in order to win new business
    • Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming

    Job Qualifications

    • BSc in a computing, life science, mathematical or statistical subject
    • Previous Lead experience as a Statistical Programmer within a biotech, CRO or pharma company
    • Excellent organizational, time management and project management skills with team leadership experience, as demonstrated by ability to organize and motivate project teams and the ability to delegate and prioritize work to meet project timelines
    • Previous oncology experience desired but not essential
    • Positive attitude and willingness to learn and contribute in a team setting and communicate effectively within the team environment
    • Good organization skills and the ability to prioritize own work
    • Self motivation and ability to work independently
    • A cooperative and team-oriented approach
    • Candidates must be fluent in English language (both verbal and written)

    go to method of application »

    Statistical Programmer 2 (CPS)

    Job Primary Functions

    • With sufficient experience assume the role of a Lead Statistical Programmer with support from senior programming staff.
    • Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
    • Responsible for the production/validation of SDTM datasets to the required specification
    • Responsible for the production of ADaM datasets and TFLs to the required specification for clinical, PK, Efficacy and PD reports
    • Interaction with external and internal clients on study related issues and technical matters
    • Provision of guidance, mentoring and training in SAS production processes and programming techniques
    • Respond to QA and client audits with support from senior programming staff

    A comprehensive full job description is available.

    Job Qualifications

    • BSc, preferably in computing, life science, mathematical or statistical subject
    • Candidates must have experience of working as a Statistical Programmer within a healthcare company within Europe or South Africa and have some exposure to Leading studies
    • Knowledge of CDISC requirements
    • Must demonstrate effective communication skills, and have proven experience of client interaction
    • Experience of performing peer review and/or dual programming of others work
    • Good organization skills and the ability to prioritize own work
    • Self motivation and ability to work independently
    • A cooperative and team-oriented approach
    • You must be fluent in English language (both verbal and written).

    go to method of application »

    Techinical Designer II - Medidata RAVE

    Summary of Opportunity

    • Development and implementation of solutions to global technical service issues and concerns regarding EDC tools like Medidata RAVE.
    • Responsible for designing the eCRF in RAVE.
    • Responsible for the preparation and /or review draft and final eCRF, edit check specifications for assigned projects to ensure quality and consistency.
    • Specification development for study build and design of EDC database.
    • Follow attention to detail approach and participate in sponsor meetings and audits/inspections.
    • Liaise with data managers to discuss technical strategies, contract obligations and timelines.
    • Responsible for performing quality control procedures for specification development.
    • Conducts team meetings and provide guidance to Programmers and Data managers.
    • Responsible for maintaining study specifications for assigned projects.
    • Responsible for conducting Quality Control of study design for assigned projects.
    • Participate in the validation of EDC studies when requested.
    • Responsible for the creation and maintenance of library objects within the Global Libraries.
    • Responsible for the review and approval of deviations and edit checks requested by the project teams.
    • Mentor and aide in staff development, and achievement of competency standards.
    • Present training programs to the technical staff regarding study build, standards maintenance, and/or change control.
    • Notify project leadership of requests for out-of-scope work and advise management of changes in scope of projects to enable the timely development of change orders.
    • Provide consultation in the area of database design and development with data managers.
    • Maintain awareness of new developments in EDC vendor products which may be applied to
      improve the efficient use of these systems.
    • Implement processes as they are refined, or as new processes are developed and initiate and
      participate in the ongoing review of the processes to ensure they are continually improved.

    Experience

    • Good knowledge of drug development process and Clinical Data Management Programming.
    • End to end Medidata RAVE build experience.
    • Technical expertise: Design Screens & Program Edits in RAVE.
    • Some experience dealing with amendments and assessing risk associated with them.
    • Good oral and written communication skills.
    • Ability to work in a team environment.
    • Ability to work effectively under minimal supervision.
    • Good time management skills and the ability to work to tight deadlines whilst maintain the highest standards of quality work.
    • Candidates must be fluent in English language (both verbal and written).

    go to method of application »

    Senior Biostatistician (FSP)

    Job Primary Functions

    • perform lead statistician role
    • preparation of SAP/mock shells
    • perform project management activities
    • perform complex statistical analyses, QC
    • review CRF and other study specific documents
    • provide statistical input to CSR, review CSR
    • present and share knowledge at team meetings
    • represent the department during client driven audits

    A comprehensive full job description is available.

    Job Qualifications

    • Master’s degree, equivalent, or higher in Biostatistics or related field
    • You must be an experienced Lead Biostatistician with ideally some oncology experience gained within a CRO/Pharma
    • Ability to program in one or more statistical software packages (SAS preferred) used to conduct statistical analyses
    • Ability to effectively communicate statistical concepts
    • You must be fluent in English language (both verbal and written

    go to method of application »

    Senior Statistical Programmer (CPS)

    Job Primary Functions

    • Perform the role of the Lead Statistical Programmer.
    • Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
    • Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
    • Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
    • Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Covance and Client standards
    • Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective
    • Mentor less-experience programmers in the processes around SDTMs, ADaMs and TFLs ensuring adherence to department practices and processes
    • Present and share knowledge at department meetings
    • Respond to QA and client audits and support qualification audits
    • Contribute to proposal activities and participate in bid defenses meetings in order to win new business
    • Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming

    Job Qualifications

    • BSc, preferably in computing, life science, mathematical or statistical subject
    • Candidates must have experience of working as a Lead Statistical Programmer within a healthcare company
    • Show evidence of and experience of leading studies and experience in study set-up and review of study specific documents
    • Knowledge of CDISC requirements
    • Positive attitude and willingness to learn and contribute in a team setting and communicate effectively within the team environment
    • Good organization skills and the ability to prioritize own work
    • Self motivation and ability to work independently
    • A cooperative and team-oriented approach
    • You must be fluent in English language (both verbal and written)

    go to method of application »

    Senior Biostatistician (CDS)

    Job Primary Functions

    • Perform Lead Biostatistician role on medium complexity studies, providing statistical oversight and attending relevant project meetings
    • Perform project management activities for identified projects including resource planning, timelines and milestone management
    • Preparation of Statistical Analysis Plans (including mock TFL shells) for medium complexity studies under the supervision of more senior statistical staff
    • Perform complex statistical analyses, quality check statistical analyses developed by other statisticians
    • Conduct overall statistical review of TFLs for complex studies prior to client delivery
    • Review CRF and other study specific specifications and plans
    • May perform sample size calculation for simple studies under the supervision of more senior statistical staff
    • Develop the statistical sections of the protocol for simple to medium complexity studies under the supervision of a statistical consultant
    • Provide statistical input and review of the CSR for medium complexity studies
    • Preparation and review of randomization specifications and generation of randomization schedules
    • Mentor of biostatisticians within project activities; assigned tasks related to the development of staff within the department
    • Present and share knowledge at team meetings and/or at monthly seminars
    • Attend bid defense meetings for medium complexity studies in order to win new business
    • Represent the department during project-driven client audits.

    Job Qualifications

    • Master’s degree, equivalent, or higher in Biostatistics or related field
    • You must have some previous experience of Leading studies as a Biostatistician in either a biotech, CRO or pharma company
    • Ability to program in one or more statistical software packages (SAS) used to conduct statistical analyses. SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis
    • Ability to effectively communicate statistical concepts
    • A good knowledge of the overall clinical trial process
    • Experience in the preparation of Statistical Analysis Plans, analysis, reporting, etc
    • You must be fluent in English language (both verbal and written)

    go to method of application »

    Principal Biostatistician (FSP)

    Job Primary Functions

    • Lead complex studies such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings
    • Perform project management activities for identified projects including resource planning, timelines and milestone management
    • Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical Consultants
    • Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians
    • Perform complex statistical analyses, quality check statistical analyses developed by other statisticians
    • Conduct overall statistical review of TFLs for complex studies prior to client delivery
    • Review CRF and other study specific specifications and plans
    • Perform complex sample size calculations under the supervision of more senior statistical staff
    • Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant
    • Provide statistic input and review of the CSR for complex studies
    • Preparation and review of randomization specifications and generation of randomization schedules
    • Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures
    • Present and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferences
    • Attend bid defense meetings for complex studies such as NDA submissions or complex, multi-protocol programs in order to win new business
    • Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives
    • Represent the department during audits.

    Job Qualifications

    • Master’s degree, equivalent, or higher in Biostatistics or related field
    • Previous experience of working as a Lead Biostatistician in either a biotech, CRO or pharma company.
    • Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses. SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis
    • Proven ability to effectively communicate statistical concepts
    • A good knowledge of the overall clinical trial process
    • Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials
    • Fluent in English language (both verbal and written).

    Method of Application

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