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inVentiv Health
Global Clinical Development Associate
PURPOSE OF THE JOB
The Global Clinical Development Associate partners with the cross-functional study team to develop the clinical strategy/plan and leads the study team in the execution of clinical trials within the clinical plan. The CDA achieves this while ensuring quality on-time and on-budget fulfillment of deliverables. The CDA supports non-trial, trial and project level assignments within the team.
CORE JOB RESPONSIBILITIES
Leadership/Project Management
" Plans and executes trial-level project management activities for assigned studies including trial-level timelines, risk assessment, mitigation plans, and other aspects of trial-level project management (e.g. budget, grants, metrics).
" Leads study team meetings.
" Develops and tracks overall trial timeline throughout the clinical trial. Networks the timeline and gains alignment with affiliates and team members on milestone dates.
" Ensures IMPACT data compliance at the trial level and utilizes Primary Document Owner (PDO) network to achieve country and site-level compliance, as appropriate.
" Manages relationships and serves as the focal point of communication between internal and external clinical research partners at the trial level.
" Proactively identifies and communicates appropriately the status of ongoing projects, issues, and risks that may affect the critical path of the clinical trial and schedule.
" Partners with Sourcing groups, Procurement, and study team to review sourcing alternatives, develop sourcing tools and provide necessary study specifications in order to obtain reliable study costs, staffing strategy, and timeline projections.
" Provides oversight of CRO performance throughout study implementation.
" Develops study training and may also coordinate/deliver training, as appropriate.
" Obtains clinical trial cost forecasts. Establishes and monitors the trial budget (grant and non-grant).
" Manages and tracks trial enrollment.
" Coordinates proposal reviews with third party vendors, and provides input to Sourcing and Procurement groups regarding needed changes in contract conditions.
" Anticipates, manages, and escalates issues as appropriate.
" Maintains and archives all trial level documentation.
" Partners with study team in the management of data locks (final and interim) and site closure.
" Partners with CPM in trial-level change controls.
Process Expertise
" Leads the Study Development Process (SDP) of compound and device trials in direct partnership with the affiliates and other medical functions.
" Develops trial level monitoring plan.
" Partners with IMPACT group and affiliate to set up portable (if applicable).
" Contributes to internal governing bodies' reviews and approvals.
" Oversees the delivery of patient narratives.
" Ensures that all study files and business databases are maintained according to policies and procedures.
" Ensures appropriate and timely completion and submission of clinical trial and regulatory documents at the affiliate and trial levels.
" Consults with Sourcing Group, Global Enrollment Optimization (GEO) and/or regional/affiliate contacts to ensure feasibility of enrollment plan, study design, and understanding of local regulatory approval requirements for successful protocol implementation.
" Initiates and coordinates the process for country allocation.
" Proactively ensures complete documentation for protocol violations, investigator/ERB information, and other elements that are required for the clinical study report or submission.
" Manages contracts and consultant agreements with external parties and organizations, as appropriate.
" May serve as gatekeeper for external non-clinical research and Investigator Initiated Trial (IIT) requests, including facilitation and coordination.
" Partners with Clinical Trial Material Management (CTMM) to ensure proper labeling, creation of drug accountability forms, reconciliation of unblinding summary, and other study CT material issues.
" Ensures inspection readiness and provides consultation and support for any type of audit.
" Ensures trial level safety review is performed.
Site Management activities (if sites are managed directly by the CDA)
" Partner with Sourcing and (Global Clinical Budgeting and Contracting ) to identify qualify and select sites and initiate contract or LoA.
" Interact closely with the investigator sites to plan and implement the trial at each site.
" Ensure compliance with the protocol and completion of the trial according to agreed timelines (including ERB and Regulatory submissions strategy)
" Manage Site budget and investigator payments
" Either perform site initiation, monitoring and close out visits or co-ordinate these with assigned monitor/CRA. Write or review monitoring reports as applicableand ensure resolution/follow up of data queries and monitoring issues. Escalate unresolved quality and/or performance issues as necessary.
Business Acumen
" Develops and utilizes appropriate study, tracking, and forecasting tools (e.g. budget, timeline projections,enrollment) throughout the trial to make wise, timely, and data-driven decisions while balancing cost, speed and quality.
" Serves as the central owner of communication across affiliate(s), functional personnel and CRO, keeping all contacts well-informed of timelines, unanticipated issues, and solutions and actions for which they are held accountable.
" Utilizes critical thinking and problem solving skills to handle assigned projects.
" Holds business partners accountable to agreed upon expectations and deliverables.
" Able to articulate and understand the compound strategy and trial priorities in relation to internal priorities and the external environment.
Scientific/Therapeutic Area Expertise
" Contributes to the effective design and implementation of clinical strategy, clinical plan, and study protocols.
" Answers protocol and technical questions from customers and business partners.
" Ensures user needs are met in device design considerations and the development of user instructions and training materials, as appropriate.
" Assists in the development of materials for various committee meetings. May be requested to present on scientific or process-related issues.
" Partners with the Clinical Research Physician (CRP) to present study information at various clinical meetings and therapeutic congresses, as needed.
" Prepares or provides scientific consultation for clinical and regulatory documents such as Investigation Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, interim study reports, final study reports, abstracts, publications and manuscripts.
" Consults and/or drafts responses to questions from Regulatory Agencies and affiliates.
" Assists in the preparation for meetings with Regulatory Agencies.
" Conducts literature searches related to assigned programs.
" Supports and contributes to the development of biomarker strategy.
Requirements:
Job Requirements:
Required:
" Bachelors degree, University degree, or equivalent work experience in a scientific or health-related field.
" Minimum of at least three years clinical research experience.
" Strong leadership and networking skills.
" Previous experience leading cross-functional and cross-cultural teams or projects.
" Strong communication skills.
" Demonstrated problem-solving abilities.
" Strong self-management and organizational skills.
Preferred:
" Previous affiliate experience.
" Demonstrated ability to work effectively cross-culturally and in a virtual work environment.
" Strong knowledge of regulations and guidelines that apply to conduct of clinical trials.
" Proficiency in use of Project Management tools such as Excel, MS Project, risk assessments, and contingency planning.
Apply:
For faster processing, please apply online and directly to the employer. Specific instructions on how to apply are available. (recommended)
Global Clinical Development Associate
PURPOSE OF THE JOB
The Global Clinical Development Associate partners with the cross-functional study team to develop the clinical strategy/plan and leads the study team in the execution of clinical trials within the clinical plan. The CDA achieves this while ensuring quality on-time and on-budget fulfillment of deliverables. The CDA supports non-trial, trial and project level assignments within the team.
CORE JOB RESPONSIBILITIES
Leadership/Project Management
" Plans and executes trial-level project management activities for assigned studies including trial-level timelines, risk assessment, mitigation plans, and other aspects of trial-level project management (e.g. budget, grants, metrics).
" Leads study team meetings.
" Develops and tracks overall trial timeline throughout the clinical trial. Networks the timeline and gains alignment with affiliates and team members on milestone dates.
" Ensures IMPACT data compliance at the trial level and utilizes Primary Document Owner (PDO) network to achieve country and site-level compliance, as appropriate.
" Manages relationships and serves as the focal point of communication between internal and external clinical research partners at the trial level.
" Proactively identifies and communicates appropriately the status of ongoing projects, issues, and risks that may affect the critical path of the clinical trial and schedule.
" Partners with Sourcing groups, Procurement, and study team to review sourcing alternatives, develop sourcing tools and provide necessary study specifications in order to obtain reliable study costs, staffing strategy, and timeline projections.
" Provides oversight of CRO performance throughout study implementation.
" Develops study training and may also coordinate/deliver training, as appropriate.
" Obtains clinical trial cost forecasts. Establishes and monitors the trial budget (grant and non-grant).
" Manages and tracks trial enrollment.
" Coordinates proposal reviews with third party vendors, and provides input to Sourcing and Procurement groups regarding needed changes in contract conditions.
" Anticipates, manages, and escalates issues as appropriate.
" Maintains and archives all trial level documentation.
" Partners with study team in the management of data locks (final and interim) and site closure.
" Partners with CPM in trial-level change controls.
Process Expertise
" Leads the Study Development Process (SDP) of compound and device trials in direct partnership with the affiliates and other medical functions.
" Develops trial level monitoring plan.
" Partners with IMPACT group and affiliate to set up portable (if applicable).
" Contributes to internal governing bodies' reviews and approvals.
" Oversees the delivery of patient narratives.
" Ensures that all study files and business databases are maintained according to policies and procedures.
" Ensures appropriate and timely completion and submission of clinical trial and regulatory documents at the affiliate and trial levels.
" Consults with Sourcing Group, Global Enrollment Optimization (GEO) and/or regional/affiliate contacts to ensure feasibility of enrollment plan, study design, and understanding of local regulatory approval requirements for successful protocol implementation.
" Initiates and coordinates the process for country allocation.
" Proactively ensures complete documentation for protocol violations, investigator/ERB information, and other elements that are required for the clinical study report or submission.
" Manages contracts and consultant agreements with external parties and organizations, as appropriate.
" May serve as gatekeeper for external non-clinical research and Investigator Initiated Trial (IIT) requests, including facilitation and coordination.
" Partners with Clinical Trial Material Management (CTMM) to ensure proper labeling, creation of drug accountability forms, reconciliation of unblinding summary, and other study CT material issues.
" Ensures inspection readiness and provides consultation and support for any type of audit.
" Ensures trial level safety review is performed.
Site Management activities (if sites are managed directly by the CDA)
" Partner with Sourcing and (Global Clinical Budgeting and Contracting ) to identify qualify and select sites and initiate contract or LoA.
" Interact closely with the investigator sites to plan and implement the trial at each site.
" Ensure compliance with the protocol and completion of the trial according to agreed timelines (including ERB and Regulatory submissions strategy)
" Manage Site budget and investigator payments
" Either perform site initiation, monitoring and close out visits or co-ordinate these with assigned monitor/CRA. Write or review monitoring reports as applicableand ensure resolution/follow up of data queries and monitoring issues. Escalate unresolved quality and/or performance issues as necessary.
Business Acumen
" Develops and utilizes appropriate study, tracking, and forecasting tools (e.g. budget, timeline projections,enrollment) throughout the trial to make wise, timely, and data-driven decisions while balancing cost, speed and quality.
" Serves as the central owner of communication across affiliate(s), functional personnel and CRO, keeping all contacts well-informed of timelines, unanticipated issues, and solutions and actions for which they are held accountable.
" Utilizes critical thinking and problem solving skills to handle assigned projects.
" Holds business partners accountable to agreed upon expectations and deliverables.
" Able to articulate and understand the compound strategy and trial priorities in relation to internal priorities and the external environment.
Scientific/Therapeutic Area Expertise
" Contributes to the effective design and implementation of clinical strategy, clinical plan, and study protocols.
" Answers protocol and technical questions from customers and business partners.
" Ensures user needs are met in device design considerations and the development of user instructions and training materials, as appropriate.
" Assists in the development of materials for various committee meetings. May be requested to present on scientific or process-related issues.
" Partners with the Clinical Research Physician (CRP) to present study information at various clinical meetings and therapeutic congresses, as needed.
" Prepares or provides scientific consultation for clinical and regulatory documents such as Investigation Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, interim study reports, final study reports, abstracts, publications and manuscripts.
" Consults and/or drafts responses to questions from Regulatory Agencies and affiliates.
" Assists in the preparation for meetings with Regulatory Agencies.
" Conducts literature searches related to assigned programs.
" Supports and contributes to the development of biomarker strategy.
Requirements:
Job Requirements:
Required:
" Bachelors degree, University degree, or equivalent work experience in a scientific or health-related field.
" Minimum of at least three years clinical research experience.
" Strong leadership and networking skills.
" Previous experience leading cross-functional and cross-cultural teams or projects.
" Strong communication skills.
" Demonstrated problem-solving abilities.
" Strong self-management and organizational skills.
Preferred:
" Previous affiliate experience.
" Demonstrated ability to work effectively cross-culturally and in a virtual work environment.
" Strong knowledge of regulations and guidelines that apply to conduct of clinical trials.
" Proficiency in use of Project Management tools such as Excel, MS Project, risk assessments, and contingency planning.
Apply:
For faster processing, please apply online and directly to the employer. Specific instructions on how to apply are available. (recommended)
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