Senior Clinical Study Manager

Please note that this position can be based in Princeton NJ or San Diego CA. Acadias hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Senior Clinical Study Manager provides end-to-end leadership for the planning execution and oversight of clinical trials across Phases 2-4 as applicable. This role is accountable for ensuring studies are conducted in full compliance with clinical protocols company SOPs applicable global regulations and the principles of Good Clinical Practice (GCP).

Serving as a key operational leader the Senior Clinical Study Manager drives study delivery through close partnership with cross-functional stakeholders and external vendors balancing quality timelines and budget to achieve study objectives. This individual plays a critical role in study strategy execution and inspection readiness bringing a proactive solutions-oriented approach to complex clinical development programs.

The ideal candidate is a highly organized collaborative leader with deep clinical operations expertise strong regulatory knowledge and the ability to manage multiple priorities in a fast-paced global environment while maintaining a relentless focus on quality and patient safety.

Primary Responsibilities

• Manages overall execution of study conduct by leading clinical study teams and represents clinical operations on multi-functional project teams both internally/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) etc. 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 are in an up-to-date status (e.g. CTMS ).
• As needed trains and mentors junior staff in study management skills and tasks.
• Other duties as assigned.

Education/Experience/Skills

• Bachelors 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.

Key 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%.

Physical Requirements

This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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Required Experience:

Manager