13 days old

Temporary Clinical Data Manager

ACADIA Pharmaceuticals
San Diego, CA 92101
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  • Job Code
    112686936

ACADIA Pharmaceuticals

U.S. Equal Opportunity Employment Information
In keeping with our commitment to the community in which we do business, and in compliance with state and federal law, ACADIA is an equal opportunity employer. Our employment policies and procedures ensure that we are committed to providing equal employment opportunities in all aspects of employment without unlawful regard to race, color, religion, national origin, ancestry, sex, sexual orientation, age, veteran's status, marital status, medical condition, and physical or mental disability. As an equal opportunity employer, we hire without consideration to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, veteran status or disability. We invite you to complete the optional self-identification fields below used for compliance with government regulations and record-keeping guidelines.


Location:
San Diego, CA - HQ


*This position is a 6 month contract.

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/Skills:

Bachelor's degree 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.

PI112686936

</br><b>ACADIA Pharmaceuticals</b></br></br>U.S. Equal Opportunity Employment Information <br> In keeping with our commitment to the community in which we do business, and in compliance with state and federal law, ACADIA is an equal opportunity employer. Our employment policies and procedures ensure that we are committed to providing equal employment opportunities in all aspects of employment without unlawful regard to race, color, religion, national origin, ancestry, sex, sexual orientation, age, veteran's status, marital status, medical condition, and physical or mental disability. As an equal opportunity employer, we hire without consideration to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, veteran status or disability. We invite you to complete the optional self-identification fields below used for compliance with government regulations and record-keeping guidelines.<br/><br/><bTemporary Clinical Data Manager</b><br/>Location:<br>San Diego, CA - HQ<br/><br/><br>*This position is a 6 month contract.<br><br>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. <br><br><u><strong>Primary Responsibilities:</strong></u><br> <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> <br><u><strong>Education/Experience/Skills: </strong></u><br><br>Bachelor's degree in Life Sciences, Mathematics or related field. An equivalent combination of relevant education and applicable job experience may be considered.<br> <ul> <li>Minimum of 2 years related experience in clinical data management. </li> </ul> <br>Must possess:<br> <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> <img src="https://analytics.click2apply.net/v/ADLn8BtOlRlmfEmjhojJ8"> <p>PI112686936</p>
Posted: 2019-08-09 Expires: 2019-09-10

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Temporary Clinical Data Manager

ACADIA Pharmaceuticals
San Diego, CA 92101

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