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 budget, in alignment with all the applicable SOPs and regulatory requirements. This position leads the Study Management Team (SMT) and interfaces with the correspondent 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 corresponding 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. Main focus is on trial management supervision, planning and coordination. As part of the End to End Process (E2E) includes trial set-up, execution, analysis and reporting (includes trial closure) and post-study activities. Measures study progress against agreed upon timelines to milestones.
• Ensure accurate budget management for assigned trials. This includes ensuring vendors and affiliate budgets are tracking according to plan. Updates are made to account for scope changes.
• Ensure compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that the SMT operates in a constant state of inspection-readiness. Ensure quality oversight of assigned trial utilizing the available tools.
• In coordination with the Clinical Program Leader, Study Responsible Scientist/Physician (SRS/SRP) and/or Clinical Leader, the GTM is responsible to ensure appropriate trial-specific training to the assigned TCSM or CRO staff as well as the site study staff. Work with TCSM (or CRO if applicable) staff in the set-up and coordination of Investigator Meetings, if applicable.
• Ensure enrollment commitments meet the projected enrollment across the regions at the clinical trial level, monitors patient recruitment at the global level, and ensure timely and accurate documentation and communication of study progress and issue escalation.
• Ensure deliverables are carried out according to the trial plan. Provides updates to all SMT and appropriate Clinical Team members on the deliverable status. Ensure required reports are generated and available for real time tracking of trial status according to trial plan.
• Strong interaction with the medical affairs team /Operating Company, other GCDO functions including Integrated Data Analyitcs and Reporting (IDAR), Pharmaceutical Development & Manufacturing Sciences (PDMS), Quantitative Sciences, Quality Management and Compliance, other research related functions (e.g., Reg Affairs) and external vendor groups, as applicable.
• As assigned, ability to lead/contribute to cross-functional/organizational process streams.
PRINCIPAL RELATIONSHIPS: Describe the primary working relationships (internal & external) and primary interfaces.
• Contacts inside the company:
• Clinical Program Leaders, Clinical Operations Heads, Other Global Trial Managers, , R&D Country Directors, R&D Country Managers, Clinical Pharmacology Project Managers, Clinical Research Managers, Local trial Managers, Site Managers, Clinical trial Assistants, Pharmacokinetic Research Managers, Finance, Central Business Operations, IDAR, IDMs, Quality Management & Training group, Quality Assurance group, and different members of the Medical Affairs Team and the Clinical Team
• Contacts outside the company: Multiple vendors, site study staff