Senior Clinical Study Manager

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. For 30 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only FDA-approved drug for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis and multiple other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at Acadia.com and follow us on LinkedIn and X.

Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Leads, plans, and oversees clinical trials (Phases 1-4 as applicable) to ensure that studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice.

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, CT.gov).
• As needed, trains and mentors junior staff in study management skills and tasks.
• Other duties as assigned.

Education/Experience/Skills

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

• 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.
• Travel approximately 25%.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use ha