Artech Information System LLC
Clinical Trial Operations Manager V(Job Id No - 4805767)
Artech Information System LLC, Bridgewater, Massachusetts, us, 02324
Clinical Trial Operations Manager V (Job Id No - 4805767)
Contract Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Responsibilities: The CTOM is responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, observational studies, compassionate use, and registries) including data management activities in compliance with GCP’s, SOPs, and standards within established timelines and budgets. The CTOM is involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee the release of homogeneous high-quality data, in close collaboration with other CSO department representatives (e.g., Medical Operations). Knowledge and Skills: Capable of interacting effectively with scientists and managers within and outside CSO SCP; serve as internal consultant on assigned area and liaise with external organizations on projects. At least 5 years’ experience in Oncology is mandatory. CTOM needs to be able to review and validate patients and data. Strong interpersonal and communication skills (verbal and written). Ability to handle multiple tasks and to prioritize, strong organizational and presentation skills. Decision-making and problem-solving skills. Ability to work autonomously and to efficiently & effectively provide status reports. Ability to anticipate and timely escalate issues and to define appropriate action plans. Good cross-functional team leader who fosters team spirit and team motivation (teamwork). Knowledge and qualification with international standards (e.g., GCP, CDISC, etc.), company tools (including data management systems), processes, and SOPs. Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc.). Ability to work in an international environment with internal and/or external partners (CROs, etc.). Strong English skills (verbal and written if English is the second language). Ability to adapt and be flexible to change and manage internal and external impediments. Understanding of database concepts preferred. Knowledge or ability to rapidly gain knowledge with programming/query languages. Knowledge of industry data management standards and practices. Formal Education and Experience Required: Bachelor's degree in a science or nursing program (advanced degree preferred) plus at least 7 years of experience in trial operations management. Principal Duties and Responsibilities: Provide oversight of a study to ensure progress according to study timelines. Lead the clinical trial team (CTT) for the operational aspects of the study. Liaise with the feasibility manager to review and assess country feasibility. Liaise with clinical purchasing to prepare the RFP, review vendors’ specifications, and oversee vendor activities and deliverables. Contribute to the extended synopsis, protocol, amendments, and WSI development and review to ensure operational feasibility. Develop study-specific procedures and write the Monitoring Plan, the Data Management Plan, and other operational documents. Ensure appropriate testing/UAT are performed as required. Ensure that clinical and data management standards are followed for the study. Organize study-specific meetings. Collect, synthesize, and report study information. Collaborate with the CSP to validate study IP needs, specifications, packaging, shipment, and reconciliation process. Define needs, tasks, and responsibilities of external vendors. Ensure preparation and proper responses to audit/inspection reports. Prepare and assist in PAI preparation plan with the PAI project team.
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Contract Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Responsibilities: The CTOM is responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, observational studies, compassionate use, and registries) including data management activities in compliance with GCP’s, SOPs, and standards within established timelines and budgets. The CTOM is involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee the release of homogeneous high-quality data, in close collaboration with other CSO department representatives (e.g., Medical Operations). Knowledge and Skills: Capable of interacting effectively with scientists and managers within and outside CSO SCP; serve as internal consultant on assigned area and liaise with external organizations on projects. At least 5 years’ experience in Oncology is mandatory. CTOM needs to be able to review and validate patients and data. Strong interpersonal and communication skills (verbal and written). Ability to handle multiple tasks and to prioritize, strong organizational and presentation skills. Decision-making and problem-solving skills. Ability to work autonomously and to efficiently & effectively provide status reports. Ability to anticipate and timely escalate issues and to define appropriate action plans. Good cross-functional team leader who fosters team spirit and team motivation (teamwork). Knowledge and qualification with international standards (e.g., GCP, CDISC, etc.), company tools (including data management systems), processes, and SOPs. Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc.). Ability to work in an international environment with internal and/or external partners (CROs, etc.). Strong English skills (verbal and written if English is the second language). Ability to adapt and be flexible to change and manage internal and external impediments. Understanding of database concepts preferred. Knowledge or ability to rapidly gain knowledge with programming/query languages. Knowledge of industry data management standards and practices. Formal Education and Experience Required: Bachelor's degree in a science or nursing program (advanced degree preferred) plus at least 7 years of experience in trial operations management. Principal Duties and Responsibilities: Provide oversight of a study to ensure progress according to study timelines. Lead the clinical trial team (CTT) for the operational aspects of the study. Liaise with the feasibility manager to review and assess country feasibility. Liaise with clinical purchasing to prepare the RFP, review vendors’ specifications, and oversee vendor activities and deliverables. Contribute to the extended synopsis, protocol, amendments, and WSI development and review to ensure operational feasibility. Develop study-specific procedures and write the Monitoring Plan, the Data Management Plan, and other operational documents. Ensure appropriate testing/UAT are performed as required. Ensure that clinical and data management standards are followed for the study. Organize study-specific meetings. Collect, synthesize, and report study information. Collaborate with the CSP to validate study IP needs, specifications, packaging, shipment, and reconciliation process. Define needs, tasks, and responsibilities of external vendors. Ensure preparation and proper responses to audit/inspection reports. Prepare and assist in PAI preparation plan with the PAI project team.
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