29 days old

Temporary, Inspection Readiness

ACADIA Pharmaceuticals
San Diego, CA 92101
  • Job Code
    114809000
ACADIA Pharmaceuticals

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

Position Summary:

This role will participate in the management of the Trial Master File system (paper or electronic) and will ensure that the clinical programs conducted by ACADIA are in a state of inspection readiness with high standards for quality. Reviews records and documents for the Trial Master File and identifies gaps and corrective actions necessary to ensure the integrity of ACADIAs systems, processes and clinical documentation are maintained in accordance with corporate and regulatory directives.

Primary Responsibilities:

  • Experience reviewing eTMF for pre-inspection GCP and data quality attributes a must (Veeva Vault experience required)
  • Experience supporting an FDA inspection and knowledge of BIMO requirements
  • Assist with the collection, review and, tracking of site-specific study/essential documents
  • Identifies and resolves deficiencies in TMF, performs ongoing reconciliation and monitors TMF regularly for completeness and accuracy
  • Ability to create and interpret metrics regarding file completeness
  • Assist/lead teams with storyboarding and risk/impact analyses of protocol deviations and/or GCP departures
  • For CRO managed trials, assists with timely reconciliation of TMF-related queries and implementation of process improvement/corrective action when needed
  • Provide training to site personnel and CSP CRA personnel, as required
  • Leads/participates in inspection readiness (IR) task force meetings
  • May take meeting minutes, develop and maintain study trackers, or assume other tasks to support study team
  • Assists with creation and review of study tools/documents

Education/Experience/Skills:

  • Requires a Bachelors degree (BA, BS or BSN) from a four-year college or university in a scientific discipline or equivalent combination of education and work experience
  • Minimum of seven (7) years pharmaceutical clinical research experience with previous roles as Senior CRA, Quality Assurance (QA), Records & Information Management (RIM) or equivalent
  • Strong knowledge and experience with the DIA Reference model for Trial Master Files; a subject matter expert to assist and support project teams on good documentation and filing practices
  • Skilled writer with good communication/ interpersonal skills
  • Knowledge of GCP/FDA/ICH regulations required
  • Have an extensive and broad understanding of clinical research
  • Have a working knowledge of the relevant SOPs
  • Be able to identify and solve problems
  • Attention to detail with the ability to prioritize and multi-task
  • Must have strong organizational skills with planning and follow-through skills
  • Ability to work well under pressure and with tight schedules
  • Self-direction and motivation are mandatory
  • Strong knowledge of MS Word, Excel, Veeva Vault systems required

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.

PI114809000

<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>This role will participate in the management of the Trial Master File system (paper or electronic) and will ensure that the clinical programs conducted by ACADIA are in a state of inspection readiness with high standards for quality. Reviews records and documents for the Trial Master File and identifies gaps and corrective actions necessary to ensure the integrity of ACADIAs systems, processes and clinical documentation are maintained in accordance with corporate and regulatory directives.</p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Experience reviewing eTMF for pre-inspection GCP and data quality attributes a must (Veeva Vault experience required)</li> <li>Experience supporting an FDA inspection and knowledge of BIMO requirements</li> <li>Assist with the collection, review and, tracking of site-specific study/essential documents</li> <li>Identifies and resolves deficiencies in TMF, performs ongoing reconciliation and monitors TMF regularly for completeness and accuracy</li> <li>Ability to create and interpret metrics regarding file completeness</li> <li>Assist/lead teams with storyboarding and risk/impact analyses of protocol deviations and/or GCP departures</li> <li>For CRO managed trials, assists with timely reconciliation of TMF-related queries and implementation of process improvement/corrective action when needed</li> <li>Provide training to site personnel and CSP CRA personnel, as required</li> <li>Leads/participates in inspection readiness (IR) task force meetings</li> <li>May take meeting minutes, develop and maintain study trackers, or assume other tasks to support study team</li> <li>Assists with creation and review of study tools/documents</li> </ul> <p><strong><u>Education/Experience/Skills:</u></strong></p> <ul> <li>Requires a Bachelors degree (BA, BS or BSN) from a four-year college or university in a scientific discipline or equivalent combination of education and work experience</li> <li>Minimum of seven (7) years pharmaceutical clinical research experience with previous roles as Senior CRA, Quality Assurance (QA), Records & Information Management (RIM) or equivalent</li> <li>Strong knowledge and experience with the DIA Reference model for Trial Master Files; a subject matter expert to assist and support project teams on good documentation and filing practices</li> <li>Skilled writer with good communication/ interpersonal skills</li> <li>Knowledge of GCP/FDA/ICH regulations required</li> <li>Have an extensive and broad understanding of clinical research</li> <li>Have a working knowledge of the relevant SOPs</li> <li>Be able to identify and solve problems</li> <li>Attention to detail with the ability to prioritize and multi-task</li> <li>Must have strong organizational skills with planning and follow-through skills</li> <li>Ability to work well under pressure and with tight schedules</li> <li>Self-direction and motivation are mandatory</li> <li>Strong knowledge of MS Word, Excel, Veeva Vault systems required</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.</p> <p> </p> <img src="https://analytics.click2apply.net/v/wyBQbECP8ErXcJVoiqaOp"> <p>PI114809000</p>

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Posted: 2019-10-24 Expires: 2019-11-24

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Temporary, Inspection Readiness

ACADIA Pharmaceuticals
San Diego, CA 92101

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