November 1st, 2022 Clinical Operations

Senior Clinical Study Manager

Princeton, New Jersey, United States

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Please be aware that Acadia has a mandatory COVID-19 vaccination policy for all employees.

Acadia is looking to bring a Senior Clinical Study Manager! This role will leads, design, plan, and potentially monitors clinical trials (Phases I –IV) to ensure that studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice.

Position Summary:

  • Leads clinical study teams and represents clinical operations on multi-function project teams internally/externally.
  • Assists in the design/review of clinical protocols, informed consent documents, and trial case report forms.
  • Leads all aspects of external vendors, including but not limited to contract research organizations (CROs) and Clinical Research Associates/Assistants.
  • Prepares or reviews (if CRO engaged) all applicable documents required for the study (Project Plan, Risk Management Plan, Protocol Deviation Management Plan, Monitoring Plan, TMF Plan) etc.
  • Drives study start-up, enrollment, and closeout for the protocol(s)
  • Liaises with other functional groups to ensure that timelines, budgets and study objectives are met
  • Provides clinical trial status updates to project teams and management.
  • Leads the clinical study budgeting and site contracting process with the legal team
  • Ensures and actively monitors and handles the internal/external study team to be in a state of inspection readiness.
  • Presents status and content at Investigator and Booster Meetings; assists with the planning and execution of study meetings
  • Is responsible for maintaining internal tracking tools in an up to date status (e.g., CTMS, CT.gov)
  • As needed, trains and mentors junior staff in study management skills and tasks

Education/Experience/Skills:

  • Bachelor’s degree in a relevant subject area.
  • An equivalent combination of education and applicable job experience may be considered. A minimum of 5 years of dynamically responsible experience in clinical trial management.
  • Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
  • Ability to work with a team with varied strengths 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 and experience in providing timely and quality support of regulatory submissions.
  • Shown 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 25%
  • Employees must be fully vaccinated against Covid-19 in accordance with our policy.
  • Must reside in the United States

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. Employee must occasionally lift and/or move up to 15 pounds. Employee must be fully vaccinated against Covid-19 in accordance with our policy and in order to meet any independent vaccination requirements that our vendors and investigators and vendor and investigator facilities may have.

#LI-Hybrid #LI-MH1

What we offer you:

  • 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:

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 [email protected] 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.