The demand for clinical roles is consistent, reflecting the ongoing need for 921 Clinical jobs in South Africa
Clinical Data Manager
R400000 - R800000 Y
IQVIA
Posted today
Job Viewed
Job Description
Looking for data management expert, who has prior experience in performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS)
Prior experience of closely collaborating with the SRP, SRS, Data Management functions and the rest of the study team members when implementing the data management related activities for protocols, with focus on more complex indication and therapy related elements of the study.
Has prior experience of being involved and driving discussions with SRP/SRS and collaborates with the Data management team to establish, align, and confirm scientific clinical data review expectations for assigned trial(s).
Extensive prior experience of 4+ years supporting studies within the therapeutic area Oncology or CV&M.
Rave experience mandatory
Deliverables:
- Services rendered will adhere to applicable Client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
- Provides scientific data review support for more than one low to moderate complexity trial or one high complexity trial.
- The data management expert who, within the therapeutic area, is performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). Tapping into technical and clinical expertise, closely collaborating with the SRP, SRS, Data Management functions and the rest of the study team members when implementing the data management related activities for protocols, with focus on more complex indication and therapy related elements of the study. Reviews all necessary data flows, the Data Management Plans and performs continuous (complex) data review activities on the studies in the assigned program.
- Involved in study related activities from the protocol design stage onwards, providing input into the study specific and/or indication specific data collection tools.
- Reviews (complex) scientific study data, manages CDM and SRS/SRP related queries in EDC system. Involvement in other review activities (e.g., Coding, SAE reconciliation) is possible.
- Leads and/or attends meetings as appropriate.
- Takes a leadership role with SRP/SRS and collaborates with the GDM to establish, align and confirm scientific clinical data review expectations for assigned trial(s).
- With the trial customer, CRO and other functional partners in relation to CDM related activities:
- Reviews content and integration requirements for eCRF and other data collection tools
- Establishes conventions and quality expectations for clinical data.
- Set timelines and follow‐up regularly to ensure delivery of all Clinical Data Management milestones
- Creates the Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Reviews related clinical data management documents. Ensures compliance with regulatory guidelines and documentation requirements.
- Ensures real‐time inspection readiness of all assigned deliverables for the trial; participate in Regulatory Agency inspection and Client internal audits as necessary.
- Plans and tracks applicable CDM deliverables. Ensures CDM deliverables are on time.
- Takes a leadership role in collaborating with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are met.
- Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.
- Identifies and participates in process, system, and tool improvement initiatives within clinical data management.
- Therapeutic Area - Oncology, Cardiovascular and Immunology
Education/Experience
- BS/BA degree or higher preferably in Health Sciences, or BS/BA degree or higher with professional clinical experience/exposure.
- 4 years Data management experience. Data Management experience preferably including clinical data review or significant experience with clinical data review. Knowledge in medical terminology would be preferable
- Must have experience in supporting the eCRF build
- Rave knowledge and experience mandatory
This role is not eligible for UK visa sponsorship
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more
This advertiser has chosen not to accept applicants from your region.
0
Clinical Data Management Lead, home-based in South Africa
North West, North West
IQVIA
Posted 19 days ago
Job Viewed
Job Description
Overview
Clinical Data Management Lead, home-based in South Africa — IQVIA, Bellville, Western Cape, South Africa
Job Details- Seniority level: Not Applicable
- Employment type: Full-time
- Job function: Research, Analyst, and Information Technology
- Industries: Pharmaceutical Manufacturing
- 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
- 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
- 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
This advertiser has chosen not to accept applicants from your region.
1
Clinical Data Management Lead, home-based in South Africa
IQVIA
Posted 19 days ago
Job Viewed
Job Description
Overview
Clinical Data Management Lead, home-based in South Africa — IQVIA, Bellville, Western Cape, South Africa
Job Details- Seniority level: Not Applicable
- Employment type: Full-time
- Job function: Research, Analyst, and Information Technology
- Industries: Pharmaceutical Manufacturing
- 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
- 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
- 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
This advertiser has chosen not to accept applicants from your region.
2
Clinical Data Management Lead, home-based in South Africa
Eastern Cape, Eastern Cape
IQVIA
Posted 19 days ago
Job Viewed
Job Description
Overview
Clinical Data Management Lead, home-based in South Africa — IQVIA, Bellville, Western Cape, South Africa
Job Details- Seniority level: Not Applicable
- Employment type: Full-time
- Job function: Research, Analyst, and Information Technology
- Industries: Pharmaceutical Manufacturing
- 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
- 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
- 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
This advertiser has chosen not to accept applicants from your region.
3
Clinical Data Management Lead, home-based in South Africa
Western Cape, Western Cape
IQVIA
Posted 19 days ago
Job Viewed
Job Description
Overview
Clinical Data Management Lead, home-based in South Africa — IQVIA, Bellville, Western Cape, South Africa
Job Details- Seniority level: Not Applicable
- Employment type: Full-time
- Job function: Research, Analyst, and Information Technology
- Industries: Pharmaceutical Manufacturing
- 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
- 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
- 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
This advertiser has chosen not to accept applicants from your region.
4
Clinical Data Management Lead, home-based in South Africa
North West, North West
IQVIA
Posted 19 days ago
Job Viewed
Job Description
Overview
Clinical Data Management Lead, home-based in South Africa — IQVIA, Bellville, Western Cape, South Africa
Job Details- Seniority level: Not Applicable
- Employment type: Full-time
- Job function: Research, Analyst, and Information Technology
- Industries: Pharmaceutical Manufacturing
- 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
- 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
- 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
This advertiser has chosen not to accept applicants from your region.
5
Clinical Data Management Lead, home-based in South Africa
IQVIA
Posted 19 days ago
Job Viewed
Job Description
Overview
Clinical Data Management Lead, home-based in South Africa — IQVIA, Bellville, Western Cape, South Africa
Job Details- Seniority level: Not Applicable
- Employment type: Full-time
- Job function: Research, Analyst, and Information Technology
- Industries: Pharmaceutical Manufacturing
- 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
- 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
- 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
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Clinical Jobs in South Africa !
6
Clinical Data Management Lead, home-based in South Africa
Gauteng, Gauteng
IQVIA
Posted 19 days ago
Job Viewed
Job Description
Overview
Clinical Data Management Lead, home-based in South Africa — IQVIA, Bellville, Western Cape, South Africa
Job Details- Seniority level: Not Applicable
- Employment type: Full-time
- Job function: Research, Analyst, and Information Technology
- Industries: Pharmaceutical Manufacturing
- 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
- 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
- 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
This advertiser has chosen not to accept applicants from your region.
7
Clinical Data Management Lead, home-based in South Africa
Gauteng, Gauteng
IQVIA
Posted 19 days ago
Job Viewed
Job Description
Overview
Clinical Data Management Lead, home-based in South Africa — IQVIA, Bellville, Western Cape, South Africa
Job Details- Seniority level: Not Applicable
- Employment type: Full-time
- Job function: Research, Analyst, and Information Technology
- Industries: Pharmaceutical Manufacturing
- 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
- 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
- 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
This advertiser has chosen not to accept applicants from your region.
8
Clinical Data Management Lead, home-based in South Africa
Gauteng, Gauteng
IQVIA
Posted 19 days ago
Job Viewed
Job Description
Overview
Clinical Data Management Lead, home-based in South Africa — IQVIA, Bellville, Western Cape, South Africa
Job Details- Seniority level: Not Applicable
- Employment type: Full-time
- Job function: Research, Analyst, and Information Technology
- Industries: Pharmaceutical Manufacturing
- 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
- 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
- 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
This advertiser has chosen not to accept applicants from your region.
9