26 days old

Clinical Data Manager II

ACADIA Pharmaceuticals
San Diego, CA 92101
  • Job Code
    115480153
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 study set-up, maintenance, data review, and database closure.

Primary Responsibilities:

Reviews protocols and provides input relevant to data management issues.

  • Monitors all data management activities within Clinical Research Organizations (CROs) and database build/maintenance within Electronic Data Capture (EDC) vendor.
  • Manages DM study activities with vendors, including external labs (transfer specifications timelines).
  • Reviews/creates 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, Serious Adverse Event (SAE) Reconciliation Plans).
  • Performs User Acceptance Testing of EDC system.
  • Performs/reviews clinical study data maintenance, data listings, enters queries, reviews 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:

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

  • Minimum of 5 years related experience in clinical data management.

Must possess:

  • Hands on training and experience in clinical trial methodology and Good Clinical Practices (GCPs).
  • Good 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).
  • Strong organizational and documentation skills.
  • Good understanding of regulatory guidance and regulations (e.g., International Conference on Harmonisation (ICH), 21CFRpart11).
  • Must be a team player who works effectively with other disciplines.
  • Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
  • Skilled at promoting team cooperation and a commitment to team success.
  • Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.

Scope:

A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways, demonstrating good judgment in selecting methods and techniques for obtaining solutions. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Normally receives little instruction on day-to-day work, general 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.


PI115480153

<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 study set-up, maintenance, data review, and database closure.</p> <p><strong><u>Primary Responsibilities:</u></strong></p> <h2> Reviews protocols and provides input relevant to data management issues.</h2> <ul> <li>Monitors all data management activities within Clinical Research Organizations (CROs) and database build/maintenance within Electronic Data Capture (EDC) vendor.</li> <li>Manages DM study activities with vendors, including external labs (transfer specifications timelines).</li> <li>Reviews/creates 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, Serious Adverse Event (SAE) Reconciliation Plans).</li> <li>Performs User Acceptance Testing of EDC system.</li> <li>Performs/reviews clinical study data maintenance, data listings, enters queries, reviews 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/Skills:</u></strong></p> <p>BS in Life Sciences or Mathematics or related field. An equivalent combination of relevant education and applicable job experience may be considered.</p> <ul> <li>Minimum of 5 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>Good 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>Strong organizational and documentation skills.</li> <li>Good understanding 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>Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.</li> <li>Skilled at promoting team cooperation and a commitment to team success.</li> <li>Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary. </li> </ul> <p><strong><u>Scope:</u></strong></p> <p>A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways, demonstrating good judgment in selecting methods and techniques for obtaining solutions. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Normally receives little instruction on day-to-day work, general 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/1wr5jGsGQP4dsAprUM8Vx"> <p>PI115480153</p>

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Posted: 2019-11-14 Expires: 2019-12-15

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Clinical Data Manager II

ACADIA Pharmaceuticals
San Diego, CA 92101

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