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  • Posted: Jan 15, 2021
    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 service company, we have helped pharmaceutical and biotech companies develop 49 of the top 50 prescription drugs in the marketplace today. Because of our broad experience and specialized expertise, we’re in a unique...

     

    Clinical Data Manager II

    Data Management leadership for all aspects of the data management process to include responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. Also assume responsibility for all data management activities leading to database lock according to Client quality expectations within project timelines and budgets.

    Lead data focused project team meetings, meeting frequently with the study leads of Electronic Data Capture (EDC) Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned, coordinated interdepartmentally, and proactively identifying potential risks and mitigations, and effectively communicating data-driven discussions in order to achieve database lock dates with the highest possible data quality.

    Essential Job Duties

    • Lead study Data Manager for studies which are medium complexity including but not limited to - combination of healthy and patient populations, multi-site, medium complexity in protocol design or client management requirements.
    • As the study data lead; be accountable for all DM deliverables per the established timeline; providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest delivery quality, while adjusting resource allocations accordingly.
    • Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
    • Work with the Project Manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary including at study initiation meetings.
    • Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of ECD Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager apprised of project progress.
    • Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on Data Management resources or deliverables and consult with Project Manager and/or functional group management as necessary.
    • Keep Project Manager, Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. work scope changes, timeline impacts).
    • Coordinates the receipt and inventory of all data related information, from clinical sites and vendors as appropriate in order to meet timelines for deliverables. Ensure all appropriate documentation and procedures are performed upon project completion.
    • Ensures study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study.
    • Develop and maintain client relationships and review client satisfaction surveys. Implement appropriate action plans including driving process improvements and team training.
    • Applies corrective interventions where necessary to maintain project budget compliance and profit expectations. Track scope changes and work with the Clinical Pharmacology Project Manager to ensure that Sponsor approval is received and the scope change processed.
    • Provides leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations.
    • Ensures service and quality meet agreed upon specifications per the DMP and scope of work.
    • Have input in writing, reviewing and updating SOPs and associated documents as required.
    • Performs QC on all aspects of work performed in DM to ensure that data quality and integrity is maintained. Feedback constructively on relevant issues and initiate process review as appropriate.
    • Maintain accurate records of all work undertaken.
    • Perform quality control on all aspects of the study as appropriate to include, but not be limited to: all study documentation, query generation and integration; to ensure that internal and client quality standards are achieved.
    • Perform reconciliation of the clinical database against safety data, laboratory data or any other third party data as appropriate. Utilise local laboratory systems and batch data load facilities where appropriate.
    • Oversee the performance of the Data Management Study team to ensure that client satisfaction is achieved through delivery of quality data, on-time and on-budget. Arrange internal or external meetings as appropriate.
    • Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.
    • Actively promote Biometrics services to sponsors whenever possible.
    • Performs other related duties as assigned by management.

    Education/Qualifications

    • 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).
    • Knowledge of drug development process.
    • Knowledge of effective clinical data management practices.
    • Fluent in English, both written and verbal.
    • In lieu of above requirement, approximately six years experience in related field (e.g. pharmaceutical, laboratory, data analysis).

    Preferred

    • Knowledge of Covance and the overall structure of the organization.
    • Knowledge of Covance standard operating procedures.

    Experience

    • Previosu combined early or late stage DM experience in DM with two years of direct sponsor management and two years of technical mentoring experience.
    • Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets.
    • Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
    • Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives and to encourage team members to seek solutions.
    • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.
    • Time management skill and ability to adhere to project productivity. metrics and timelines.
    • Ability to work in a team environment and collaborate with peers
    • Good organizational ability, communication and inte.rpersonal skills.
    • Team working skills and good collaborator skills
    • Constructive problem solving attitude while deadline focused with time demands, incomplete information or unexpected events.
    • Knowledge of medical terminology.
    • Knowledge of science or a scientific background is preferred.
    • Good oral and written communication skills.

    Preferred

    • Through knowledge of Covance, the overall structure of the organization and Standard Operating Procedures (SOPs).
    • Four or more years of Electronic Data Capture experience.
    • Experience as a hands on Data Manager with capability of leading and driving all study related deliverables to ensure client expectations are being met in a timely manner and within budget.

    go to method of application »

    Junior Associate Clinical Data Manager

    Joining Covance will offer a rewarding career, a chance to work in an energetic & team-oriented workplace, and access to competitive benefits. Ou Data Management team in Early Phase are looking for a Junior Associate Clinical Data Manager in Europe.

    Your Role

    • Serve as back-up to the Lead Clinical Data Manager, with oversight of data management activities and assist with maintaining a close liaison with project client contacts, core team members, and Project Managers to drive the data management aspects of project delivery.
    • Serve as a member of the project team with primary responsibility for coordinating the clinical data review, query generation / resolution and reconciliation activities to support the Lead Clinical Data Manager with the delivery of clinical data according to client quality and integrity specifications, project timelines and productivity targets.
    • Assist in the development of the project documentation including Data Manage Plan, Edit Check Specification, Data Review Guideline and Data Transfer Agreements.
    • Assist in the setup of the clinical database (EDC) according to project requirements.
    • Assist with database decommissioning and create required documentation.
    • May act as a Lead Data Manager for lower complexity studies with oversight from management and a Lead Clinical Data Manager.

    Education/Qualifications:

    • 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).
    • Knowledge of the drug development process.
    • Knowledge of effective clinical data management practices.
    • Fluent in English, both written and verbal.
    • In lieu of above requirement, graduates and entry level

    Experience:

    • Previous experience with demonstration of superior organizational and time management skills within a clinical or data management setting.
    • Additional experience may be substituted for education requirements.
    • Knowledge of medical terminology.
    • Knowledge of clinical data management preferred.
    • Knowledge of science or a scientific background is preferred.
    • Good oral and written communication skills.
    • Demonstrate time management skill and ability to adhere to project productivity metrics and timelines.
    • Demonstrate ability to work in a team environment and collaborate with peers.
    • Demonstrate good organizational ability, communication and interpersonal skills.
    • Demonstrate team working skills and good collaborator skills.
    • Demonstrate a constructive problem solving attitude while deadline focused with time demands, incomplete information or unexpected events.

    go to method of application »

    Lead Data Manager


    Are you a self-starter who knows how to take initiative in your daily work? Would you enjoy making a real difference in the lives of others.

    If you are looking for a high-energy position in a collaborative environment, learn more about the Lead Data Manager opportunity with Covance.

    In This Role, You Will

    • Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.
    • Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
    • Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.
    • Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
    • Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to these specifications.
    • Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions.
    • Coordinate the development and testing of data management systems edit / data validation checks) diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
    • Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
    • Advanced planning and risk management for projects (issue escalation, resource management).
    • Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
    • Assist with goal creation and performance review assessment for data review project staff.
    • Maintain technical data management competencies via participation in internal and external training seminars.
    • Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.
    • Identify areas for process and efficiency improvement and implement solutions on assigned projects.
    • Support achievement of project revenue and operating margin for data management activities to agreed targets.
    • Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary.
    • Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
    • Review literature and research technologies/procedures for improving global data management practices.
    • Perform other duties as assigned

    Education/Qualifications:

    • Previousrelevant work experience in data management with approximately one (1) year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
    • Excellent oral and written communication and presentation skills.
    • In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
    • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.

    Experience:

    • 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.
    • Broad knowledge of drug development processes.
    • Understanding of global clinical development budgets and relationship to productivity targets.
    • Knowledge of effective clinical data management practices.
    • Knowledge of time and cost estimate development and pricing strategies.
    • Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.

    go to method of application »

    Clinical Operations Manager

    Covance has supported the pharmaceutical industry worldwide in developing more medicines than any other company, including the top 50 best-selling drugs on the market today. Our highly dedicated, supportive teams work on bringing drugs to market that have a real impact on the lives and health of people. If you are looking for a position in which you can leverage your organizational skills as much as your French and English language skills, this is the perfect opportunity. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers.

    What we have to offer: a strong international support network, a genuine work-life balance, an attractive compensation package, great learning and career growth opportunities, and the chance to work with some of the most innovative pharmaceutical companies in the world.

    Sounds exciting? Then we would love to hear from you!

    We are currently recruiting a Clinical Operations Manager responsible for the recruitment, growth, and development of Clinical Operations team members. The position is based in the Gauteng area.

    Education/Qualifications

    University degree with strong emphasis in science, pharmacy and/or biology

    Extensive Knowledge Of

    • Drug development process and client needs.
    • ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.

    Experience:

    • Relevant experience as a line manager
    • Relevant clinical research experience in a pharmaceutical company or CRO
    • Site Management Monitoring experience in South Africa: monitoring international clinical studies
    • Thorough knowledge of drug development process and thorough knowledge of relevant SOPs, ICH, and GCP guidelines
    • Proficiency with on site monitoring activities
    • Ability to resolve project-related problems and prioritize workload for self and team

    go to method of application »

    Project Manager, Start-up

    About the department: This department provides an quality-focused approach to the study start-up phase of site activations with an emphasis on flexibility, collaboration, and efficiency. Our SUPMs oversee and manage multi-functional teams in order to deliver on time Ready to Enrol milestones for our clients. This is an excellent client facing opportunity to develop your career, communications and soft skills, as well take on more responsibilities and be involved in cutting edge global studies.

    Responsibilities

    Expert in, project start-up and related maintenance activities for a particular study/studies on a regional and/or global level as well as excellent communication skills to support client relationships. Responsible for leading, ensuring and overseeing, start-up and/or maintenance activities on projects, on time, within budget, and in compliance with SOPs and/or other quality and regulatory requirements. Depending on the scope of the project and experience level, job duties may be performed independently as a Lead SUPM or in collaboration with a Lead SUPM as a Regional SUPM.

    Education/Qualifications

    Education/Qualifications:

    • University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
    • Working knowledge of financial control procedures (e.g. costing systems, time reporting).
    • Working knowledge of project management processes, especially regarding study start-up.
    • Working knowledge of time and cost estimate development.
    • Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
    • Broad knowledge of drug development process and client needs.

    go to method of application »

    SAS Senior Programmer Analyst

    As a Programmer Analyst you will be writing edit checks and reports for clinical trials, dedicated to one of our Sponsors.

    This Role Requires

    • Data management experience including familiarity with reading study documentation and understanding study structure
    • UNIX experience a definite plus
    • 3+ years of SAS experience are required
    • Bachelor’s degree required
    • Broad knowledge of drug development process.
    • Working knowledge of CDISC.
    • Working knowledge of System Life Cycle in relationship to the implementation new applications.
    • Fluent in English, both written and verbal.

    Education/Qualifications:

    • Bachelor’s degree required

    Experience:

    • Broad knowledge of drug development process.
    • Working knowledge of CDISC.
    • Working knowledge of System Life Cycle in relationship to the implementation new applications.
    • Fluent in English, both written and verbal.

    go to method of application »

    Clinical Data Manager

    Are you a self-starter who knows how to take initiative in your daily work? Would you enjoy making a real difference in the lives of others.

    If you are looking for a high-energy position in a collaborative environment, learn more about the Lead Data Manager opportunity with Covance.

    In This Role, You Will

    • Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.
    • Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
    • Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.
    • Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
    • Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to these specifications.
    • Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions.
    • Coordinate the development and testing of data management systems edit / data validation checks) diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
    • Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
    • Advanced planning and risk management for projects (issue escalation, resource management).
    • Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
    • Assist with goal creation and performance review assessment for data review project staff.
    • Maintain technical data management competencies via participation in internal and external training seminars.
    • Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.
    • Identify areas for process and efficiency improvement and implement solutions on assigned projects.
    • Support achievement of project revenue and operating margin for data management activities to agreed targets.
    • Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary.
    • Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
    • Review literature and research technologies/procedures for improving global data management practices.
    • Perform other duties as assigned

    Education/Qualifications:

    • Minimum five (5) years relevant work experience in data management with approximately one (1) year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
    • Excellent oral and written communication and presentation skills.
    • In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
    • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.

    Experience:

    • 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.
    • Broad knowledge of drug development processes.
    • Understanding of global clinical development budgets and relationship to productivity targets.
    • Knowledge of effective clinical data management practices.
    • Knowledge of time and cost estimate development and pricing strategies.
    • Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.

    go to method of application »

    Associate Clinical Data Manager

    Data Management leadership for all aspects of the data management process to include but not limited to the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. Also assume responsibility for all data management activities leading to database lock according to Client quality expectations, within project timelines and budgets.

    Develop and maintain a close liaison with project client contacts, core team members, and Project Managers to drive the data management aspects of project delivery.

    Essential Job Duties

    • Lead study Data Manager for studies considered to be lower complexity either in terms of study design or client management.
    • As the study data lead; be accountable for all DM deliverables per the established timeline; providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest delivery quality, while adjusting resource allocations accordingly.
    • Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
    • Work with the Project Manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary including at site initiation meetings.
    • Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on Data Management resources or deliverables and consult with Project Manager and/or functional group management as necessary.
    • Keep Clinical Pharmacology Project Manager, Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. work scope changes, timeline impacts).
    • Anticipates and identifies operational and logistical challenges; including mitigation plans and risk management plans and reviews them with the Project Manager, Biometrics management, and the sponsor. Executes follow-through of mitigation plans to completion in a timely manner.
    • Coordinates the receipt and inventory of all data related information, from clinical sites and vendors as appropriate in order to meet timelines for deliverables. Ensure all appropriate documentation and procedures are performed upon project completion.
    • Ensures study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study.
    • Applies corrective interventions where necessary to maintain project budget compliance and profit expectations. Track scope changes and work with the Project Manager to ensure that Sponsor approval is received and the scope change processed.
    • Demonstrates knowledge of DM utilized tools, systems, and processes.
    • Ensures service and quality meet agreed upon specifications per the DMP and scope of work.
    • Plan Data Management resources for assigned studies with support from line manager
    • Maintain accurate records of all work undertaken.
    • Perform quality control on all aspects of the study as appropriate to include, but not be limited to: all study documentation, query generation and integration; to ensure that internal and client quality standards are achieved.
    • Perform reconciliation of the clinical database against safety data, laboratory data or any other third party data as appropriate. Utilise local laboratory systems and batch data load facilities where appropriate.
    • Perform medical and medication coding.
    • Performs QC on all aspects of work performed in DM to ensure that data quality and integrity is maintained. Feedback constructively on relevant issues and initiate process review as appropriate.
    • Support and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.
    • Actively promote Biometrics services to sponsors whenever possible.
    • Performs other related duties as assigned by management.

    Education/Qualifications

    • 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).
    • Knowledge of drug development process.
    • Knowledge of effective clinical data management practices.
    • Fluent in English, both written and verbal.
    • In lieu of above requirement, approximately four years’ experience in related field (e.g. pharmaceutical, laboratory, data analysis).

    Preferred

    • Knowledge of Covance and the overall structure of the organization.
    • Knowledge of Covance standard operating procedures.

    Experience

    • Four years of combined early or late stage Data Management experience with one year of direct sponsor management and one year technical mentoring experience.
    • Proven experience of handling customer negotiations and exposure to managing Scope of Work and budgets.
    • Knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
    • Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives and to encourage team members to seek solutions.
    • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.
    • Time management skill and ability to adhere to project productivity metrics and timelines.
    • Ability to work in a team environment and collaborate with peers.
    • Good organizational ability, communication and interpersonal skills.
    • Team working skills and good collaborator skills.
    • Constructive problem solving attitude while deadline focused with time demands, incomplete information or unexpected events.
    • Knowledge of medical terminology.
    • Knowledge of science or a scientific background is preferred.
    • Good oral and written communication skills.

    Preferred

    • Through knowledge of Covance, the overall structure of the organization and Standard Operating Procedures (SOPs).
    • Two or more years of Electronic Data Capture experience.

    go to method of application »

    Lead Data Manager

    Are you a self-starter who knows how to take initiative in your daily work? Would you enjoy making a real difference in the lives of others.

    If you are looking for a high-energy position in a collaborative environment, learn more about the Lead Data Manager opportunity with Covance.

    In This Role, You Will

    • Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.
    • Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
    • Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.
    • Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
    • Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to these specifications.
    • Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions.
    • Coordinate the development and testing of data management systems edit / data validation checks) diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
    • Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
    • Advanced planning and risk management for projects (issue escalation, resource management).
    • Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
    • Assist with goal creation and performance review assessment for data review project staff.
    • Maintain technical data management competencies via participation in internal and external training seminars.
    • Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.
    • Identify areas for process and efficiency improvement and implement solutions on assigned projects.
    • Support achievement of project revenue and operating margin for data management activities to agreed targets.
    • Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary.
    • Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
    • Review literature and research technologies/procedures for improving global data management practices.
    • Perform other duties as assigned by manager

    Education/Qualifications:

    • 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.
    • Broad knowledge of drug development processes.
    • Understanding of global clinical development budgets and relationship to productivity targets.
    • Knowledge of effective clinical data management practices.
    • Knowledge of time and cost estimate development and pricing strategies.
    • Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.

    Experience:

    • Previous years relevant work experience in data management with technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
    • Demonstrated skill for technical management of staff exceeding 5 employees.
    • Financial management of gross revenues in excess of $250K per year.
    • Excellent oral and written communication and presentation skills.
    • In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
    • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
    • Ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
    • Demonstrated managerial and interpersonal skills

    Method of Application

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