Senior Clinical Study Manager

Role Summary

The Senior Clinical Study Manager provides end-to-end leadership for planning, execution, and oversight of clinical trials across Phases 2-4, ensuring studies are conducted in full compliance with protocols, SOPs, global regulations, and Good Clinical Practice (GCP). This role partners with cross-functional stakeholders and external vendors to balance quality, timelines, and budget, guiding study strategy, execution, and inspection readiness in a fast-paced, global environment.

Responsibilities

• Manages overall execution of study conduct by leading clinical study teams and represents clinical operations on multi-functional project teams, both internally and externally.
• Assists in the design/review of clinical protocols, informed consent documents, and trial case report forms.
• Oversees external vendors to ensure execution against timelines and budget, and appropriate address of quality issues.
• Prepares or reviews (if CRO engaged) all applicable documents required for the conduct of the study (Project Plan, Risk Management Plan, Protocol Deviation Management Plan, Monitoring Plan, TMF Plan) and ensures cross-functional alignment.
• Drives study start-up, enrollment and closeout for the protocol(s).
• Liaises with other functional groups to ensure timelines, budgets and study objectives are met.
• Provides clinical trial status updates to project teams and management.
• Manages the clinical study budgeting and site contracting process with the legal team.
• Ensures and actively monitors and manages the internal/external study team to be in a state of inspection readiness.
• Leads or provides oversight with the planning and execution of study meetings, including relevant investigator meetings.
• Responsible for identifying vendor issues and ensuring any relevant actions.
• Responsible for maintaining tracking tools in an up-to-date status (e.g., CTMS, CT.gov).
• As needed, trains and mentors junior staff in study management skills and tasks.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in life science or related field.
• Targeting 5 years of progressively responsible experience in clinical trial management.
• An equivalent combination of relevant education and experience may be considered.

Skills

• Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
• Ability to work with a diverse team of individuals, often in a global capacity, where sensitivity, respect and an appreciation for different working norms may be present.
• Practical experience in clinical trial methods and processes; strong knowledge of clinical trial design.
• Knowledge of local and global regulatory pharmaceutical requirements by providing timely and quality support of regulatory submissions.
• Clinical study management or project management experience desired.
• Demonstrated technical, administrative, problem solving and project management experience.
• A solutions-oriented approach to working cross-functionally with a team of individuals to deliver stated goals and objectives.
• Must be able and willing to travel on occasion, up to 25%.

Education

• Bachelor’s degree in life science or related field

Additional Requirements

• Travel up to 25% (as needed to support study activities and sites).