8 days old

Clinical Data Manager I

ACADIA Pharmaceuticals
San Diego, CA 92101
  • Job Code
    117989501
ACADIA Pharmaceuticals

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

Position Summary:

As part of the Data Management team, responsible for study- specific data management activities, including assisting with study set-up and performing maintenance, data review and database closure.

Primary Responsibilities:

  • Assists with data management activities within CROs and database build/maintenance within EDC vendor.
  • Assists with review/creation of study specific data management documentation (i.e. Data Management Plans, Database Specifications, Edit Check Specifications, clinical data query handling and resolution, Vendor data Reconciliation Plans, SAE Reconciliation Plans, etc.).
  • Performs User Acceptance Testing of EDC system.
  • Performs clinical study data maintenance, data listings, enter queries, review query resolutions.
  • Performs Validation of SAS programming within Data Management.
  • Provides input on general data management documents such as SOPs, standards, templates.
  • Other duties as assigned.

Education/Experience:

BS in Life Sciences, Mathematics or related field. An equivalent combination of relevant education and applicable job experience may be considered.

  • Minimum of 2 years related experience in clinical data management.

Must possess:

  • Hands on training and experience in clinical trial methodology and Good Clinical Practices (GCPs).
  • Basic understanding of all aspects involved in the data management responsibilities throughout a clinical trial.
  • Experience with, and practical understanding of, at least one clinical data management system (e.g., Medidata Rave, Inform, Clintrial)
  • Good organizational and documentation skills.
  • Knowledge of regulatory guidance and regulations (e.g. International Conference on Harmonisation (ICH), 21CFRpart11).
  • Must be a team player who works effectively with other disciplines.
  • 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:

Applies company policies and procedures to analyze situations or data and to resolve a variety of problems. Normally receives guidance on day to day work and detailed instructions on new 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. Employee must occasionally lift and/or move up to 15 pounds.


PI117989501

<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>As part of the Data Management team, responsible for study- specific data management activities, including assisting with study set-up and performing maintenance, data review and database closure.</p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Assists with data management activities within CROs and database build/maintenance within EDC vendor.</li> <li>Assists with review/creation of study specific data management documentation (i.e. Data Management Plans, Database Specifications, Edit Check Specifications, clinical data query handling and resolution, Vendor data Reconciliation Plans, SAE Reconciliation Plans, etc.).</li> <li>Performs User Acceptance Testing of EDC system.</li> <li>Performs clinical study data maintenance, data listings, enter queries, review query resolutions.</li> <li>Performs Validation of SAS programming within Data Management.</li> <li>Provides input on general data management documents such as SOPs, standards, templates.</li> <li>Other duties as assigned.</li> </ul> <p><strong><u>Education/Experience: </u></strong></p> <p>BS in Life Sciences, Mathematics or related field. An equivalent combination of relevant education and applicable job experience may be considered.</p> <ul> <li>Minimum of 2 years related experience in clinical data management.</li> </ul> <p>Must possess:</p> <ul> <li>Hands on training and experience in clinical trial methodology and Good Clinical Practices (GCPs).</li> <li>Basic understanding of all aspects involved in the data management responsibilities throughout a clinical trial.</li> <li>Experience with, and practical understanding of, at least one clinical data management system (e.g., Medidata Rave, Inform, Clintrial)</li> <li>Good organizational and documentation skills.</li> <li>Knowledge of regulatory guidance and regulations (e.g. International Conference on Harmonisation (ICH), 21CFRpart11).</li> <li>Must be a team player who works effectively with other disciplines.</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>Applies company policies and procedures to analyze situations or data and to resolve a variety of problems. Normally receives guidance on day to day work and detailed instructions on new 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. Employee must occasionally lift and/or move up to 15 pounds. </p> <p><em><span style="font-weight: 400;"><br/></span></em></p> <img src="https://analytics.click2apply.net/v/j7kdyGtj1mOYFRZ6uxyPa"> <p>PI117989501</p>

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Posted: 2020-02-12 Expires: 2020-03-14

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Clinical Data Manager I

ACADIA Pharmaceuticals
San Diego, CA 92101

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