Acadia Pharmaceuticals Inc. · 12 hours ago
Senior Clinical Study Manager
Princeton, NJ
Full-time
Hybrid
Senior Level
$131K/yr - $164K/yr
5+ years expAcadia Pharmaceuticals is committed to innovation in neurological and rare disease treatments. The Senior Clinical Study Manager will lead the planning, execution, and oversight of clinical trials, ensuring compliance with protocols and regulations while managing cross-functional teams and external vendors.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
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
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%
Benefits
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
Company
Acadia Pharmaceuticals Inc.
Acadia Pharmaceuticals develops and commercializes small molecule drugs for the treatment of central nervous system disorders.
501-1000 employees
H1B Sponsorship
Acadia Pharmaceuticals Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$811.73MKey Investors
National Institute of Neurological Disorders and StrokeOxford Bioscience PartnersNational Institute of Mental Health
2019-09-17Post Ipo Equity· $287.5M
2018-11-30Post Ipo Equity· $316.25M
2013-01-02Post Ipo Equity· $86.39M
Leadership Team
Catherine Adams
Chief Executive Officer
Steve Davis
President and CEO
Recent News
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