Integrated Resources Inc.
Global Trial Manager-III
Integrated Resources Inc., Horsham, Pennsylvania, United States, 19044
A Few Words About Us
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-state's most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy, and Nursing.
Job Description
POSITION SUMMARY:
The position is accountable for the successful execution of clinical activities assigned by the Functional Manager, Clinical Program Leader, or Clinical Operations Head, within agreed timelines and budgets, in alignment with all applicable SOPs and regulatory requirements. This position leads the Study Management Team (SMT) and interfaces with Clinical Teams, other Global Clinical Development Operations (GCDO) functions, Regional Trial Coordination/Site Management (TCSM) colleagues, Study Sites (if applicable), Central Business Operations, finance, and the medical affairs team/Operating Company. Alignment of goals with organizational objectives as defined in the GCDO cascades. Principal Responsibilities
Considered the study owner and leader of the SMT, focusing on trial management supervision, planning, and coordination across all trial phases, including setup, execution, analysis, reporting, and post-study activities. Measure study progress against timelines and milestones. Ensure accurate budget management for trials, tracking vendor and affiliate budgets and updating for scope changes. Ensure compliance with global health authority regulations and internal SOPs. Participate in Health Authority inspections and internal QA audits to ensure inspection readiness. Oversee trial quality using available tools. Coordinate with Clinical Program Leaders, Study Responsible Scientists/Physicians, and Clinical Leaders to ensure appropriate trial-specific training for staff and investigators. Organize Investigator Meetings as needed. Monitor patient recruitment and enrollment commitments across regions, ensuring timely documentation and escalation of issues. Ensure deliverables adhere to the trial plan, providing status updates and generating reports for real-time tracking. Collaborate with medical affairs, GCDO functions, external vendors, and other research-related groups to ensure smooth trial operations. Lead or contribute to cross-functional process improvements as assigned. Principal Relationships
Internal contacts include Clinical Program Leaders, Clinical Operations Heads, Global Trial Managers, R&D Directors and Managers, Clinical Pharmacology Project Managers, Research Managers, Site Managers, Clinical Trial Assistants, Pharmacokinetic Research Managers, Finance, Central Business Operations, IDAR, IDMs, Quality Management & Training, and Medical Affairs Teams. External contacts involve vendors and site study staff. Qualifications
Education and Experience: Bachelor’s degree or equivalent, preferably in Life Sciences (Biology, Chemistry, Biochemistry, Nursing, Pharmacy). Minimum of 8 years of clinical trial experience in the pharmaceutical industry or CRO, with at least 7 years in Oncology clinical trial management or large safety registries and real-world experience trials. Strong operational knowledge in clinical research, project management, vendor management, and systems. Excellent decision-making, financial management, and leadership skills. Experience managing global/regional teams in virtual environments. Proficient in computer literacy. Additional Information
Warm Regards, Clinical Recruiter Integrated Resources, Inc IT REHAB CLINICAL NURSING Tel: (732) 549 5307 Fax: (732) 549 5549 Inc. 5000 - 2007-2014 (8th Year)
#J-18808-Ljbffr
POSITION SUMMARY:
The position is accountable for the successful execution of clinical activities assigned by the Functional Manager, Clinical Program Leader, or Clinical Operations Head, within agreed timelines and budgets, in alignment with all applicable SOPs and regulatory requirements. This position leads the Study Management Team (SMT) and interfaces with Clinical Teams, other Global Clinical Development Operations (GCDO) functions, Regional Trial Coordination/Site Management (TCSM) colleagues, Study Sites (if applicable), Central Business Operations, finance, and the medical affairs team/Operating Company. Alignment of goals with organizational objectives as defined in the GCDO cascades. Principal Responsibilities
Considered the study owner and leader of the SMT, focusing on trial management supervision, planning, and coordination across all trial phases, including setup, execution, analysis, reporting, and post-study activities. Measure study progress against timelines and milestones. Ensure accurate budget management for trials, tracking vendor and affiliate budgets and updating for scope changes. Ensure compliance with global health authority regulations and internal SOPs. Participate in Health Authority inspections and internal QA audits to ensure inspection readiness. Oversee trial quality using available tools. Coordinate with Clinical Program Leaders, Study Responsible Scientists/Physicians, and Clinical Leaders to ensure appropriate trial-specific training for staff and investigators. Organize Investigator Meetings as needed. Monitor patient recruitment and enrollment commitments across regions, ensuring timely documentation and escalation of issues. Ensure deliverables adhere to the trial plan, providing status updates and generating reports for real-time tracking. Collaborate with medical affairs, GCDO functions, external vendors, and other research-related groups to ensure smooth trial operations. Lead or contribute to cross-functional process improvements as assigned. Principal Relationships
Internal contacts include Clinical Program Leaders, Clinical Operations Heads, Global Trial Managers, R&D Directors and Managers, Clinical Pharmacology Project Managers, Research Managers, Site Managers, Clinical Trial Assistants, Pharmacokinetic Research Managers, Finance, Central Business Operations, IDAR, IDMs, Quality Management & Training, and Medical Affairs Teams. External contacts involve vendors and site study staff. Qualifications
Education and Experience: Bachelor’s degree or equivalent, preferably in Life Sciences (Biology, Chemistry, Biochemistry, Nursing, Pharmacy). Minimum of 8 years of clinical trial experience in the pharmaceutical industry or CRO, with at least 7 years in Oncology clinical trial management or large safety registries and real-world experience trials. Strong operational knowledge in clinical research, project management, vendor management, and systems. Excellent decision-making, financial management, and leadership skills. Experience managing global/regional teams in virtual environments. Proficient in computer literacy. Additional Information
Warm Regards, Clinical Recruiter Integrated Resources, Inc IT REHAB CLINICAL NURSING Tel: (732) 549 5307 Fax: (732) 549 5549 Inc. 5000 - 2007-2014 (8th Year)
#J-18808-Ljbffr