Clinical Trial Manager / Clinical Study Manager (97458)
Title of Position: Clinical Trials Manager
Job Description:
This position coordinates various multi-disciplinary teams to meet clinical trial objectives. With the goals for the entire development program in mind, provides substantive contributions to the strategic design and execution of a clinical trials program. The CTM continuously evaluates the progression, quality, and cost of the various operational steps involved in planning and execution of a clinical program. Additionally, (s)he independently formulates corrective actions for identified issues and drives the implementation thereof. Dependent on the level of trial outsourcing, the CTM will appropriately adjust the degree of CRO/vendor oversight. The CTM may oversee a portfolio of studies being managed by a strategic/preferred CRO provider. At the departmental level, the CTM will contribute to the development and revision of relevant SOPs and internal processes. The CTM will formulate recommendations to departmental heads on complex and important problems as they arise. The CTM will take on a leadership role by acting as a resource and providing mentorship to less experienced colleagues.
Key
Responsibilities:
Oversee clinical trial planning
Contributes to clinical development planning as it relates to operational considerations
Develops operational study implementation and execution strategy
Identifying resourcing needs for assigned projects, including internal and external outsourced services (i.e., CROs, laboratories, contractors, in-house staff, etc.); participates in the request for proposal process including defining expectations and deliverables; assesses qualifications and experience, and participate in final selection process
Defines site qualification criteria and oversees the identification of potential investigators and clinical sites; oversees, performs or participates (as needed) in pre-study site visits, reviews evaluative reports; participates in the final selection of study sites
Defines the site approval process with respect to critical document requirements, Institutional Review Board (IRB) approvals, IRB questions, site informed consent review, and review of contracts, in conjunction with relevant internal departments (as necessary)
Develops Program/Study/Investigator Budgets, and performs ongoing analysis related to study progress and/or work being performed by outside vendors (CROs, CRAs, centralized laboratories, etc)
Oversees and participates in Investigator Meetings
Ensures timely development of clinical trial documentation (e.g. informed consent documents, case report forms (CRFs), CRF guidelines, statistical/ pharmacokinetic analysis plans, monitoring plan, data management plans including edit check specifications, CTA template, etc)
Develops Investigator Relationship & Maintenance Plan
Assesses project related internal/external educational needs
Assesses study drug requirements and shipment logistics; contributes to labeling strategy.
Develops oversight plan for Clinical Operations; ensures Data Management and Safety Oversight plans are developed; ensures appropriate sponsor oversight documentation is generated
Monitors clinical trial progress
Assesses adequacy and comprehensiveness of study / program tracking systems
Responsible for all performance metrics and quality of deliverables in a clinical trial
Oversees the day-to-day activities of the clinical trial and associated resources (CROs, CRAs, centralized laboratories, etc.)
Identifies and evaluates issues related to the project and coordinates resolutions
Continuously evaluates compliance to applicable SOPs and the quality of site monitoring and associated documentation; develops corrective action plan if indicated
Ensures appropriate transmission of CRF data to data management team and reviews queries as necessary
Identifies data deficiencies and discrepancies, and coordinates corrective action as required
Ensures adequate Serious Adverse Event reporting including documentation, tracking and follow-up
Assists in the site audit process and coordinates the audit responses to ensure conformance to industry and company standards
Oversees close-out processes and ensures final site issues are addressed appropriately
Coordinates CSR writing, review and approval process including the compilation of all required sections
Drives successful study completion
Minimum Basic
Qualifications:
Bachelor's degree in scientific/clinical related discipline is required
At least 9 years relevant industry experience in a clinical research setting, including but not limited to CRO oversight for large-scale international program
Preferred Qualifications and
Experience:
Has managed and led multiple cross-functional processes involved in Clinical Research, specifically trial management
Knowledge of the infrastructure and operational characteristics of CROs and centralized services
In-depth understanding of industry standards including ICH guidelines, GCPs, compliance, and the CFR.
Technical expert in the various aspects of the clinical trial process
Has significantly contributed to the success of planning and executing clinical trials in support of an overall clinical development plan
Proficient in development of clinical trial documentation (e.g. informed consent documents, case report forms (CRFs), CRF guidelines, statistical/ pharmacokinetic analysis plans, monitoring plan, data management plans including edit check specifications, CTA template, etc)
Understand the roles/responsibilities and inter-dependencies for key functions involved in clinical development
Familiarity with study / program tracking system
Competencies:
Ability to anticipate what will be needed in the future and take initiative to meet those needs
Strong work ethic with perseverance to achieve results
Ability to break down complex problems into lists of actionable items
Keen understanding how the CTM interacts with others' roles to most effectively advance trial objectives
Excellent communication, writing and presentation skills
Ability to lead and organize team meetings.
Ability to foster effective relationships with vendors, investigators and colleagues.
Estimated Salary: $20 to $28 per hour based on qualifications.
Job Description:
This position coordinates various multi-disciplinary teams to meet clinical trial objectives. With the goals for the entire development program in mind, provides substantive contributions to the strategic design and execution of a clinical trials program. The CTM continuously evaluates the progression, quality, and cost of the various operational steps involved in planning and execution of a clinical program. Additionally, (s)he independently formulates corrective actions for identified issues and drives the implementation thereof. Dependent on the level of trial outsourcing, the CTM will appropriately adjust the degree of CRO/vendor oversight. The CTM may oversee a portfolio of studies being managed by a strategic/preferred CRO provider. At the departmental level, the CTM will contribute to the development and revision of relevant SOPs and internal processes. The CTM will formulate recommendations to departmental heads on complex and important problems as they arise. The CTM will take on a leadership role by acting as a resource and providing mentorship to less experienced colleagues.
Key
Responsibilities:
Oversee clinical trial planning
Contributes to clinical development planning as it relates to operational considerations
Develops operational study implementation and execution strategy
Identifying resourcing needs for assigned projects, including internal and external outsourced services (i.e., CROs, laboratories, contractors, in-house staff, etc.); participates in the request for proposal process including defining expectations and deliverables; assesses qualifications and experience, and participate in final selection process
Defines site qualification criteria and oversees the identification of potential investigators and clinical sites; oversees, performs or participates (as needed) in pre-study site visits, reviews evaluative reports; participates in the final selection of study sites
Defines the site approval process with respect to critical document requirements, Institutional Review Board (IRB) approvals, IRB questions, site informed consent review, and review of contracts, in conjunction with relevant internal departments (as necessary)
Develops Program/Study/Investigator Budgets, and performs ongoing analysis related to study progress and/or work being performed by outside vendors (CROs, CRAs, centralized laboratories, etc)
Oversees and participates in Investigator Meetings
Ensures timely development of clinical trial documentation (e.g. informed consent documents, case report forms (CRFs), CRF guidelines, statistical/ pharmacokinetic analysis plans, monitoring plan, data management plans including edit check specifications, CTA template, etc)
Develops Investigator Relationship & Maintenance Plan
Assesses project related internal/external educational needs
Assesses study drug requirements and shipment logistics; contributes to labeling strategy.
Develops oversight plan for Clinical Operations; ensures Data Management and Safety Oversight plans are developed; ensures appropriate sponsor oversight documentation is generated
Monitors clinical trial progress
Assesses adequacy and comprehensiveness of study / program tracking systems
Responsible for all performance metrics and quality of deliverables in a clinical trial
Oversees the day-to-day activities of the clinical trial and associated resources (CROs, CRAs, centralized laboratories, etc.)
Identifies and evaluates issues related to the project and coordinates resolutions
Continuously evaluates compliance to applicable SOPs and the quality of site monitoring and associated documentation; develops corrective action plan if indicated
Ensures appropriate transmission of CRF data to data management team and reviews queries as necessary
Identifies data deficiencies and discrepancies, and coordinates corrective action as required
Ensures adequate Serious Adverse Event reporting including documentation, tracking and follow-up
Assists in the site audit process and coordinates the audit responses to ensure conformance to industry and company standards
Oversees close-out processes and ensures final site issues are addressed appropriately
Coordinates CSR writing, review and approval process including the compilation of all required sections
Drives successful study completion
Minimum Basic
Qualifications:
Bachelor's degree in scientific/clinical related discipline is required
At least 9 years relevant industry experience in a clinical research setting, including but not limited to CRO oversight for large-scale international program
Preferred Qualifications and
Experience:
Has managed and led multiple cross-functional processes involved in Clinical Research, specifically trial management
Knowledge of the infrastructure and operational characteristics of CROs and centralized services
In-depth understanding of industry standards including ICH guidelines, GCPs, compliance, and the CFR.
Technical expert in the various aspects of the clinical trial process
Has significantly contributed to the success of planning and executing clinical trials in support of an overall clinical development plan
Proficient in development of clinical trial documentation (e.g. informed consent documents, case report forms (CRFs), CRF guidelines, statistical/ pharmacokinetic analysis plans, monitoring plan, data management plans including edit check specifications, CTA template, etc)
Understand the roles/responsibilities and inter-dependencies for key functions involved in clinical development
Familiarity with study / program tracking system
Competencies:
Ability to anticipate what will be needed in the future and take initiative to meet those needs
Strong work ethic with perseverance to achieve results
Ability to break down complex problems into lists of actionable items
Keen understanding how the CTM interacts with others' roles to most effectively advance trial objectives
Excellent communication, writing and presentation skills
Ability to lead and organize team meetings.
Ability to foster effective relationships with vendors, investigators and colleagues.
Estimated Salary: $20 to $28 per hour based on qualifications.
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