26 days old

Senior Clinical Data Manager

ACADIA Pharmaceuticals
San Diego, CA 92101
  • Job Code
    114673988
ACADIA Pharmaceuticals

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

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

Here's an overview of the tasks and responsibilities:

  • Reviews protocols and provides input relevant to data management issues.
  • Oversees/leads all data management activities for clinical studies either directly or overseeing a Clinical Research Organization (CRO).
  • Manages DM study activities with vendors, including external labs (transfer specifications and timelines) and Electronic Data Capture (EDC) vendor (DB build, User Acceptance Testing (UAT), maintenance, and lock)
  • Collaborates with other departments on clinical study start up (e.g. case report form (CRF) design), clean up, and closeout.
  • Responsible for study-specific DM documentation including the Data Management Plan, database creation/validation including edit checks, and query generation/resolution.
  • Responsible for clinical study data maintenance, data listings, entering queries, reviewing query resolutions, etc.
  • Provides input on general data management documents such as SOPs and CRF templates.

Interested? Heres what we need from you:

BA/BS in Life Sciences or equivalent combination of relevant education and applicable job experience.

Minimum 8 years of experience in clinical data management.

Bonus points for:

  • Hands on training and experience in clinical trial methodology and Good Clinical Practice.
  • Excellent understanding of all aspects involved in the data management responsibilities throughout a clinical trial.
  • Experience with Medidatas Rave system including strong J-Review skills.
  • Proficient organizational and documentation skills.
  • Excellent written and verbal communication skills.
  • Strong understanding of regulatory guidance and regulations (eg. International Conference on Harmonisation (ICH), 21CFR Part 11, etc.).
  • Strong understanding of CDISC and CDASH standards.
  • Must be a team player who works effectively with other disciplines.


PI114673988

<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>As part of the Data Management (DM) team, responsible for study-specific data management activities, including study set up, maintenance, data review, and database closure.</p> <p><strong>Here's an overview of the tasks and responsibilities:</strong><strong> </strong></p> <ul> <li>Reviews protocols and provides input relevant to data management issues.</li> <li>Oversees/leads all data management activities for clinical studies either directly or overseeing a Clinical Research Organization (CRO).</li> <li>Manages DM study activities with vendors, including external labs (transfer specifications and timelines) and Electronic Data Capture (EDC) vendor (DB build, User Acceptance Testing (UAT), maintenance, and lock)</li> <li>Collaborates with other departments on clinical study start up (e.g. case report form (CRF) design), clean up, and closeout.</li> <li>Responsible for study-specific DM documentation including the Data Management Plan, database creation/validation including edit checks, and query generation/resolution.</li> <li>Responsible for clinical study data maintenance, data listings, entering queries, reviewing query resolutions, etc.</li> <li>Provides input on general data management documents such as SOPs and CRF templates.</li> </ul> <p><strong>Interested? Heres what we need from you:</strong></p> <p>BA/BS in Life Sciences or equivalent combination of relevant education and applicable job experience.</p> <p>Minimum 8 years of experience in clinical data management.</p> <p><strong>Bonus points for:</strong></p> <ul> <li>Hands on training and experience in clinical trial methodology and Good Clinical Practice.</li> <li>Excellent understanding of all aspects involved in the data management responsibilities throughout a clinical trial.</li> <li>Experience with Medidatas Rave system including strong J-Review skills.</li> <li>Proficient organizational and documentation skills.</li> <li>Excellent written and verbal communication skills.</li> <li>Strong understanding of regulatory guidance and regulations (eg. International Conference on Harmonisation (ICH), 21CFR Part 11, etc.).</li> <li>Strong understanding of CDISC and CDASH standards.</li> <li>Must be a team player who works effectively with other disciplines.</li> </ul> <p><em><span style="font-weight: 400;"><br/></span></em></p> <img src="https://analytics.click2apply.net/v/6e7QBeiz1x7mC8lwCoK4n"> <p>PI114673988</p>

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Posted: 2019-10-18 Expires: 2019-11-18

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Senior Clinical Data Manager

ACADIA Pharmaceuticals
San Diego, CA 92101

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