Senior Clinical Study Manager
Job Description
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 hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.
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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. Actual amounts will vary depending on experience, performance, and location.
What we offer you (US-Based Employees):
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- 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
- 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave
- Tuition assistance
EEO Statement (US-Based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. 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 would strongly encourage you to apply - especially if the reason you are the best candidate isn't exactly as we describe it 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.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia's career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at talentacquisition@acadia-pharm.com or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
Notice for California Applicants: Please see our California Applicant Privacy Notice within our Privacy Policy.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. ("Acadia"). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with the respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity
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