Clinical Operations
ACADIA Pharmaceuticals Inc., San Diego, CA, United States
Please note that this position can be based in Princeton, NJ, or San Diego, CA. Acadia's 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.
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 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.
What we offer US-based Employees
Competitive base, bonus, new hire and ongoing equity packages
Medical, dental, and vision insurance
Employer-paid life, disability, business travel and EAP coverage
401(k) Plan with a fully vested company match 1:1 up to 5%
Employee Stock Purchase Plan with a 2-year purchase price lock-in
15+ vacation days
13 -15 paid holidays, including office closure between December 24th and January 1st
10 days of paid sick time
Paid parental leave benefit
Tuition assistance
In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance.
Salary Range $131,000—$163,600 USD
EEO Statement
We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
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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.
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 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.
What we offer US-based Employees
Competitive base, bonus, new hire and ongoing equity packages
Medical, dental, and vision insurance
Employer-paid life, disability, business travel and EAP coverage
401(k) Plan with a fully vested company match 1:1 up to 5%
Employee Stock Purchase Plan with a 2-year purchase price lock-in
15+ vacation days
13 -15 paid holidays, including office closure between December 24th and January 1st
10 days of paid sick time
Paid parental leave benefit
Tuition assistance
In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance.
Salary Range $131,000—$163,600 USD
EEO Statement
We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
#J-18808-Ljbffr