- Responsible for the coordination and execution of epidemiological and related clinical studies, including complex protocols, according to ICH-GCP, Good Epidemiology Practices and required regional regulations as applicable in support of the development strategy for vaccine
- Responsible for the overall management of assigned study conduct, including oversight of the CRO and all other clinical vendors.
- Responsibility for the development and management of all operational timelines and budgets for assigned trials. Identifies issues that may impact the overall program plan (quality/timelines/cost) and initiates contingency plans as appropriate
- Provide leadership and expertise in the global clinical operational strategy, directing project teams to support the epidemiological and related clinical studies defined in the Integrated Clinical Development plans for vaccines and ensure integration into overall debvelpment, ensuring all studies are executed in accordance with Code of Federal Regulations, Good Clinical Practices, Good Epidemiology Practices, ICH Guidelines, and all applicable local regulations.
- Manage full scope of study conduct ensuring studies are conducted according to the Code of Federal Regulations, Good Clinical Practices, Good Epidemiology Practices, ICH Guidelines, local regulatory requirements and Takeda SOPs
- Member of the Regional Study Team, coordinating cross-functional efforts of Trial Operations Management, Site Operations, Analytical Sciences, Pharmacovigilance and all other appropriate functional departments to achieve study objectives and goals
- Co-ordinates with all relevant groups (Trial Operations Management, Site Operations, Clinical Sciences, Analytical Sciences etc) to develop and manage epidemiological project timelines and overall epidemiological study budget
- Co-ordinates meetings with study team members as appropriate for the project. Disseminates epidemiological project communication to all functional groups as appropriate
- Contributes to protocol synopsis development and Clinical Operations feasibility assessments
- Writing of study protocols, amendments and administrative changes based on approved protocol synopsis, in collaboration with Program Manager and other cross functional groups
- Participation in the selection of CRO and all clinical vendors for assigned studies.
- For studies outsourced to a CRO, may work with Trial Operations Management to ensure adequate evaluation by the CRO of study investigators
- Provides oversight of vendors which includes communicating expectations and timelines, ensuring deliverables are on time, with no quality issues.
- Planning and participation in investigator meetings in collaboration with all cross-functional team members
- Ensure training of all cross-functional team members and vendors on the protocol and expectations of the study
- Identify resource issues with external providers and escalate issues to Program Manager
- Responsible for managing assigned studies within budget; provides latest best estimate of study budget and provides guidance to Program Manager on changes to study budget
- Responsible for identifying vendor issues and bringing to the attention of the Program Manager for discussion. Provides input to problem-solving and implements corrective action plan when necessary
- Partners with Trial Operations Management and CRO, where applicable, to resolve site issues
- Partners with Trial Operations Management and/or vendors for resolution of corrective actions as a result of QA audit and/or regulatory inspections
- Escalate issues relevant to medical personnel as appropriate for medical monitoring, safety, and exemptions/deviations
- Maintain project tracking system with current study status and provide accurate progress reports on assigned studies as requested
- Collaborate with clinical supplies to ensure appropriate and timely drug supply for assigned studies
- Review and input to Epidemiological Study Report
- Participate in training of junior personnel and new hires
- May participate in Clinical Operations initiatives to enhance processes
Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Bachelor’s degree or RN required; MS, PharmD, or PhD preferred
- Minimum of five years experience in clinical and epidemiological research. Practical experience in protocol development (study design) and a solid understanding of the operational execution of epidemiological protocols.
- Experience in clinical trial development and monitoring is an added value.
- Good comprehension of drug development and clinical trial and epidemiological methodology
- Good understanding of GEP/GCP/ICH/FDA requirements and an ability to assess compliance to these guidelines
- Willing to travel as necessary (i.e. investigator meetings, seminars or company meetings etc)
- Must exercise good judgment to maintain confidentiality and ensure integrity of data
- Must work effectively in a matrix team environment and be flexible to contribute to the needs of the group
Knowledge and Skills
- Communication skills- demonstrated ability to be clear, direct, and tactful when communicating
- Demonstrated basic business and medical writing skills required for protocols amendments, study summaries, and progress reports.
- Problem Solving – Begin to participate in strategic planning. Able to anticipate potential problems and obstacles and plan accordingly
- Demonstrated ability to organize and manage multiple vendors participating in clinical studies
- Demonstrated ability to prioritize work effectively to meet timelines
- Budget Management – demonstrated ability to develop an study budget to monitor and control expenditures; provides justification/rationale for budget variances
- Demonstrates professional and effective presentation skills
- Leadership skills-Ability to stand in for Program Manager back-up as needed
- Analytical skills – demonstrated ability to identify study-related, CRO-related or site-related issues, determines the causes and possible solutions to the problem. Responsible for resolving issues with study conduct with appropriate staff and CRO for a clinical study. Good judgment, professionalism and independence are needed in interfacing with staff, CROs, study coordinators, and investigators
- Technical Competency - displays in-depth knowledge of clinical and epidemiological study procedures and maintains an awareness of environment as it affects clinical study execution
- Demonstrated ability to provide input to managing external vendor resources related to study conduct
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to sit and stand for long periods of time.
- Carrying, handling and reaching for objects.
- Ability to lift and carry over 25 pounds.
- Manual dexterity to operate office equipment i.e. computers, phones, etc.
- Access to transportation to attend various meetings held in proximity to the Takeda offices
- Able to fly to various meetings at investigator, vendor or regulatory agency sites
- Some international travel will be required
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