Manager Clinical Study Lead – Internal Medicine

Manager Clinical Study Lead – Internal Medicine

Requirements

• A minimum of a Bachelor’s degree is required
• 6+ years of direct clinical trial experience
• Direct experience managing global clinical trial operations is a must
• Experience developing protocols and key study documents
• Technical proficiency in trial management software and MS applications

Responsibilities

• Accountable for the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out
• Leads the cross-functional study team responsible for clinical study delivery
• Provides operational input into protocol development
• Oversees and provides input to the development of study specific documentation
• Ensures compliance with the clinical trial registry requirements
• Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
• Provides input into baseline budget development and management
• Leads risk assessment and identifies risk mitigation strategies at the study level
• Leads the feasibility assessment to select relevant regions and countries for the study
• Oversees/conducts site evaluation and selection
• Leads investigator meeting preparation and execution
• Monitors progress for site activation and monitoring visits and acts on any deviations from plan
• Leads the development of and oversees implementation of patient recruitment and retention strategies
• Monitors data entry and query resolution and acts on any deviations from agreed metrics
• Ensures accurate budget management and scope changes for internal and external studies
• Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
• Escalates issues related to study conduct, quality, timelines or budget to Program Operations Lead (POL) and other stakeholders
• Oversees the execution of the clinical study against planned timelines, deliverables and budget
• Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
• Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
• Ensure clinical project audit and inspection readiness through the study lifecycle
• Supports internal audit and external inspection activities and contributes to CAPAs as required
• Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
• Contributes to clinical study report writing and review
• Facilitates and contributes to study level lessons learned
• Assigns tasks to Clinical Study Management staff and supports their deliverables
• Recommends and participates in cross-functional and departmental process improvement initiatives
• Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs
• Responsible for direct supervision of CTM staff

Preferred Qualifications

• Demonstrated interpersonal & leadership skills
• Ability to understand and implement the operational strategic direction and guidance for respective clinical studies
• A data driven approach to planning, executing, and problem solving
• Effective communication skills via verbal, written and presentation abilities
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• Ability to influence and negotiate across key stakeholders
• An awareness of relevant industry trends
• Ability to build productive study teams and collaborations
• Demonstrated vendor management experience
• Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
• Experience in global clinical trial operations including experience developing protocols and key study documents
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Effective project management skills, cross-functional team leadership and organizational skills