22 days old

Temporary Clinical Study Manager

ACADIA Pharmaceuticals
Princeton, NJ 08540
  • Job Code
    115005062
ACADIA Pharmaceuticals

ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

Position Summary:

Provides assistance in the design, planning, and potential monitoring of Phase 1 clinical trials to ensure that studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice.

Primary Responsibilities:

  • Participates on clinical project teams and may represent clinical operations on multi-function projects teams internally/externally.
  • Assists the Sr. Clinical Study Manager on all relevant clinical tasks associated with a clinical trial.
  • Assists in the design/review of clinical protocols and trial case report forms.
  • Assists in the preparation or review (if CRO engaged) of designated applicable documents required for the conduct of the study (Project Plan, Risk Management, Monitoring Plan, TMF) etc.
  • 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.
  • Tracks the clinical study budgets.
  • May run small scope clinical trials independently.
  • Other responsibilities as assigned.

Education/Experience/Skills:

Bachelors degree in a scientific discipline. A minimum of 5 years progressively responsible experience in clinical research with a focus on managing Phase 1 clinical trials is required. Equivalent combination of education and applicable job experience may be considered.

Must possess:

  • Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
  • 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.
  • Project management experience.
  • Skilled at presenting information in a clear, concise manner to all levels within the department.
  • Skilled at contributing on a consistent basis to team initiatives in a thorough and timely manner.
  • Able to react to changing situations in a timely, calm, and confident manner.

Scope:

Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined policies and procedures to determine appropriate actions and resolve a variety of issues. Normally receives general instructions on routine work, detailed instructions on new projects or assignments.

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 by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues.


PI115005062

<b>ACADIA Pharmaceuticals</b><br/><br/>ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity</em><br/><br/><p><strong><u>Position Summary:</u></strong></p> <p>Provides assistance in the design, planning, and potential monitoring of Phase 1 clinical trials to ensure that studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice.</p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Participates on clinical project teams and may represent clinical operations on multi-function projects teams internally/externally.</li> <li>Assists the Sr. Clinical Study Manager on all relevant clinical tasks associated with a clinical trial.</li> <li>Assists in the design/review of clinical protocols and trial case report forms.</li> <li>Assists in the preparation or review (if CRO engaged) of designated applicable documents required for the conduct of the study (Project Plan, Risk Management, Monitoring Plan, TMF) etc.</li> <li>Liaises with other functional groups to ensure that timelines, budgets and study objectives are met</li> <li>Provides clinical trial status updates to project teams and management.</li> <li>Tracks the clinical study budgets.</li> <li>May run small scope clinical trials independently.</li> <li>Other responsibilities as assigned.</li> </ul> <p><strong><u>Education/Experience/Skills:</u></strong></p> <p>Bachelors degree in a scientific discipline. A minimum of 5 years progressively responsible experience in clinical research with a focus on managing Phase 1 clinical trials is required. Equivalent combination of education and applicable job experience may be considered.</p> <p>Must possess:</p> <ul> <li>Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.</li> <li>Practical experience in clinical trial methods and processes; strong knowledge of clinical trial design.</li> <li>Knowledge of local and global regulatory pharmaceutical requirements and experience in providing timely and quality support of regulatory submissions.</li> <li>Project management experience.</li> <li>Skilled at presenting information in a clear, concise manner to all levels within the department.</li> <li>Skilled at contributing on a consistent basis to team initiatives in a thorough and timely manner.</li> <li>Able to react to changing situations in a timely, calm, and confident manner.</li> </ul> <p><strong><u>Scope:</u></strong></p> <p>Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined policies and procedures to determine appropriate actions and resolve a variety of issues. Normally receives general instructions on routine work, detailed instructions on new projects or assignments.</p> <p><strong><u>Physical Requirements:</u></strong></p> <p>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 by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues.</p> <p><em><span style="font-weight: 400;"><br/></span></em></p> <img src="https://analytics.click2apply.net/v/JBGGZ6CppVGNcPJVfXd5P"> <p>PI115005062</p>

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Posted: 2019-10-31 Expires: 2019-12-01

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Temporary Clinical Study Manager

ACADIA Pharmaceuticals
Princeton, NJ 08540

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