​​Essential Functions/Responsibilities

• ​In partnership with the study team and internal and external service providers, provides oversight to ensure study delivery and ensure operational excellence.

• ​Delegate tasks to study team members as appropriate.

• ​Lead implementation, execution and management of global Phase I–IV clinical trials.

• ​Lead, facilitate and delegate trial-related meetings, ensuring alignment withcross-functional teams.

• ​Act as a primary point of escalation for cross-functional stakeholders for timelyissue resolution and alignment.

• ​Participate in program-level discussions (FMT, GPT), providing clear and timely updates to senior management (as needed).

• ​Develop and execute clinical trial strategies in collaboration with cross-functional teams during the trial lifecycle including tracking and reporting trial progress, risks and mitigation strategies to senior leadership.

• ​Hold overall accountability for the Trial Master File (TMF). Acts as an SME for Clinical Operations related sections.

• ​Lead the development and review of trial—specific plans and essential clinical trial documents.

• ​Review and approve key trial documents including protocols, informed consent forms, monitoring plans, and Clinical Study Reports (CSRs) in line with Standard Operating Procedures (SOPs).

• ​Actively contributes to the operational oversight and strategic direction of assigned studies, including feasibility assessments, planning, vendor selection, patient recruitment strategies, and financial forecasting.

• ​Contribute to the planning and conduct of Investigator Meetings, including driving meeting preparation, presenting trial materials, and supporting effective delivery of key messages. ​

• ​Identify, assess, and proactively manage risk and contingencies to safeguard timelines, quality and compliance.

• ​Develop, manage and tracktrial timelines and budgets, in line with projected spend. Estimate, track and critically analyze vendor financial spend on trials.

• ​Accountable for the oversight and management of external service providers and vendors to ensure quality, compliance, and performance.

• ​Oversee trial tracking activities and ensure accurate, timely updates within trial management systems.

• ​Accountable for final approval and oversight of trial documentation archiving in compliance with regulatory and company requirements.

• ​Serves as trial lead and SME during audits and inspections.

• ​Coordinate Investigational Medicinal Product (IMP) shipment authorization with regulatory and clinical supplies functions.

• ​Assist and support data query process.

• ​Perform monitoring visit report review(as required).

• ​Lead and participate in Clinical Operations / Global Clinical Development Operations (GCDO) initiatives(as assigned).

• ​Serves as a Clinical Operations SME in the design and reviewof processes.

• ​Ensure trial activities are conducted according to GCP and relevant SOPs and in accordance with the agreed timelines and trial protocol.

• ​Leadership / People Management Responsibilities:

• ​Mentor and coach Global Study Managers (GSMs)Clinical Research Associates (CRAs), and Global Study Associates (GSAs) to support professional development.

• ​Lead Clinical Trial Working Groups (CTWGs).

• ​Provide leadership in resolving complex trial issues and escalating risks appropriately.

• ​Manage and maintainhigh performing clinical teams.

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​Required Knowledge, Skills, and Abilities

• ​7+ years of clinical research experience, with proven global trial management and portfolio-level oversight with a minimum of 3years in clinical operations leadership roles.

• ​Excellent organizational skills, time-management and attention to detail.

• ​Excellent written and verbal communication skills and stakeholder management abilities.

• ​Ability to work both independently and collaboratively in a fast-paced environment.

• ​Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).​

• ​Experience with and strong knowledge of Clinical Trial electronic systems (e.g., TMF, Clinical Trial Management System (CTMS), etc.).

• ​Strong knowledge of clinical trial processes, ICH-GCP, and regulatory requirements.

• ​Strong knowledge of regulatory start up process and planning in support of StudyStart-Up (SSU).

• ​Proven track record of effectivelymanaging in a cross-functional environment.

• ​Excellent project management skills with a proven track record of managing global, multi-center clinical trials.

• ​Strong leadership and governance experience; ability to influence at senior levels.

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​Required/Preferred Education and Licenses

• ​Bachelor’s degree, preferably in life sciences, healthcare, or a related field, or equivalent experience.

• ​Advanced degree preferred.