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  • Posted: Sep 12, 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 ...
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    Senior Data Management Lead

    Responsibilities

    • Serve as primary point of contact for customer on data management deliverables
    • Manage multiple large studies or program of studies (possibly global)
    • Provide leadership and senior support to DTLs on multiple large global programs of global studies
    • Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
    • Lead direct negotiations with customer, e.g., timelines, financial, process, resources
    • Meet with Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
    • Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
    • Serve as the escalation point for unresolved data issues
    • Ensure appropriate resources are assigned to meet project deliverables
    • Create and/or review and sign-off on all data management plan (DMP) documents
    • Manage service performance and provide leadership to identify root causes of issues and implement remedial actions
    • Serve as Subject Matter Expert (SME)
    • Provide leadership and expertise in a specific CDM task or technology
    • Independently manage SOW/budget
    • Independently bring process improvements and solutions to the CDM team/CDM department
    • Lead a focus team or global or local best practice team
    • Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions

    Required Knowledge, Skills And Abilities

    • Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients)
    • Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation)
    • Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently
    • Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
    • Knowledge of operating procedures and work instructions and the ability to apply them in practice
    • Knowledge of Good Clinical Practices and relevant regulatory guidelines
    • Excellent communication, interpersonal, customer service, and teamwork skills
    • Excellent organizational and problem-solving skills
    • Excellent project management skills
    • Ability to work independently
    • Comprehensive understanding of clinical drug development process
    • Ability to establish and maintain effective working relationships with co-workers, managers and customers

    Minimum Required Education And Experience

    • Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
    • Around 7 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience

    go to method of application »

    Data Management Lead , home-based in South Africa-Bloemfontein

    Data Team Lead, home-based
    You’ll be responsible for managing end-to-end delivery of data management services for multi-service projects, ensuring quality deliverables on time and within budget. You will direct the team in areas of project planning, execution, financial management, communications and milestone deliverables.

    Main Responsibilities

    • Provide leadership and vision to the team
    • Manage and deliver several large scale, high complexity/non-standard aspect studies across a range of sponsors and Therapeutic areas
    • Manage sponsors at both Study and Programme Level
    • Manage delivery of areas requiring specific expertise (e.g Process, Finance)
    • Ensure milestones meet timelines and quality deliverables
    • Provide project management expertise working with customer data managers, key decision makers and internal team members to manage continuous process improvements and provide technical expertise
    • Ensure open communications with customer and Quintiles management to manage and meet contractual obligations
    • Provide input for and perform direct negotiations with customer
    • Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
    • Support DM service delivery with comprehensive DM process and technical expertise in executing projects
    • Create and/or review and sign-off on all data management plan (DMP) documents
    • Track service performance and provide leadership to identify root causes of issues and implement remedial actions
    • Serve as the escalation point for unresolved data issues; work with client data managers, vendors, internal team members for resolution
    • Maintain internal tracking databases and systems

    Minimum Education & Experience

    • Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
    • Around 5 years direct Data Management experience, including 3 or more years as a Clinical Data Management project lead is preferred
    • Ability to maintain strong customer relationships

    go to method of application »

    Data Team Lead, home-based in South Africa-Centurion

    Data Team Lead, home-based

    You’ll be responsible for managing end-to-end delivery of data management services for multi-service projects, ensuring quality deliverables on time and within budget. You will direct the team in areas of project planning, execution, financial management, communications and milestone deliverables.

    Main Responsibilities

    • Provide leadership and vision to the team
    • Manage and deliver several large scale, high complexity/non-standard aspect studies across a range of sponsors and Therapeutic areas
    • Manage sponsors at both Study and Programme Level
    • Manage delivery of areas requiring specific expertise (e.g Process, Finance)
    • Ensure milestones meet timelines and quality deliverables
    • Provide project management expertise working with customer data managers, key decision makers and internal team members to manage continuous process improvements and provide technical expertise
    • Ensure open communications with customer and Quintiles management to manage and meet contractual obligations
    • Provide input for and perform direct negotiations with customer
    • Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
    • Support DM service delivery with comprehensive DM process and technical expertise in executing projects
    • Create and/or review and sign-off on all data management plan (DMP) documents
    • Track service performance and provide leadership to identify root causes of issues and implement remedial actions
    • Serve as the escalation point for unresolved data issues; work with client data managers, vendors, internal team members for resolution
    • Maintain internal tracking databases and systems

    Minimum Education & Experience

    • Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
    • Around 5 years direct Data Management experience, including 3 or more years as a Clinical Data Management project lead is preferred
    • Ability to maintain strong customer relationships

    go to method of application »

    Data Team Lead, home-based in South Africa- Kimberley

    Data Team Lead, home-based

    You’ll be responsible for managing end-to-end delivery of data management services for multi-service projects, ensuring quality deliverables on time and within budget. You will direct the team in areas of project planning, execution, financial management, communications and milestone deliverables.

    Main Responsibilities

    • Provide leadership and vision to the team
    • Manage and deliver several large scale, high complexity/non-standard aspect studies across a range of sponsors and Therapeutic areas
    • Manage sponsors at both Study and Programme Level
    • Manage delivery of areas requiring specific expertise (e.g Process, Finance)
    • Ensure milestones meet timelines and quality deliverables
    • Provide project management expertise working with customer data managers, key decision makers and internal team members to manage continuous process improvements and provide technical expertise
    • Ensure open communications with customer and Quintiles management to manage and meet contractual obligations
    • Provide input for and perform direct negotiations with customer
    • Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
    • Support DM service delivery with comprehensive DM process and technical expertise in executing projects
    • Create and/or review and sign-off on all data management plan (DMP) documents
    • Track service performance and provide leadership to identify root causes of issues and implement remedial actions
    • Serve as the escalation point for unresolved data issues; work with client data managers, vendors, internal team members for resolution
    • Maintain internal tracking databases and systems

    Minimum Education & Experience

    • Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
    • Around 5 years direct Data Management experience, including 3 or more years as a Clinical Data Management project lead is preferred
    • Ability to maintain strong customer relationships

    Method of Application

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