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17 days old

Associate Director of Clinical Operations For CNS-Focused Sponsor

Kelly Services
Paramus, NJ 07652
**Clinical Operations, Associate Director (CNS)**


**On-site/Remote, Direct Hire**


**Paramus, NJ 07652**


**Summary**


CNS-focused pharmaceutical company notable for being the first Korea-based company to discover, develop and commercialize a molecule from inception through FDA approval without partnering or out-licensing. The company has 28 years of experience in R&D and highly dedicated to changing the status quo in CNS with 8 current compounds in the clinical development pipeline.


This role requires excellent interpersonal skills, presentation skills and leadership skills and general knowledge of clinical trial database structure and technical aspects of clinical trial conduct. Can also include day to day management of operations staff members.


**The Associate Director of Clinical Operations is responsible for:**


+ Leading multi-disciplinary team CMC, Drug Supply, Regulatory, Pharmacovigilance, Clinical, PM, Legal, Medical Affairs in the design, start-up, conduct and closure of assigned clinical studies.

+ Managing vendors required for trial conduct Chair study team meetings with vendor and internal team meetings

+ Providing oversight with SMEs for design and finalization of clinical study protocols, and production of relevant clinical trial analyses including first impressionable results, interim analyses, CSR With the assistance of program management provide budget planning and track invoice

+ Providing input into development of study regulatory documents including health authority/IRB response, DSUR, annual reports etc.

+ Providing review and coordinate review of function experts and participate in due diligence activities in evaluation of early development products.

+ Providing direct management to clinical trial associates/managers


**Supervision Exercised:**


+ Supervisory responsibility may include managing 1-3 direct reports in the operations group including Clinical trial associates, Grade A Clinical trial leads, Clinical trial managers, Grade B Senior clinical trial managers, Grade C,

+ Responsibility may include leading a team in a matrix environment.


**Qualifications**


+ Education Preferred: Variable; MS or PhD in relevant science

+ Work Experience: 6-8 years of experience with combination of operational expertise and experience in data collection and evaluation.

+ Good writing skills


**Physical and Mental Requirements:**


+ Ability to multitask

+ Adapts to change, adjust change and grasps information quickly

+ Maintain composure under pressure

+ Ability to follow verbal or written instructions and use of effective verbal communications

+ Examine and observe details


**Other** : Requires some **travel 10-25%** including Investigator meetings, site visits and/or travel for annual scientific meetings.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-10-04 Expires: 2021-11-04

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Associate Director of Clinical Operations For CNS-Focused Sponsor

Kelly Services
Paramus, NJ 07652

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