Amy Bertram

Amy Bertram Email and Phone Number

Data Management Team Lead at Parexel @ Parexel
Amy Bertram's Location
Saugus, Massachusetts, United States, United States
Amy Bertram's Contact Details

Amy Bertram personal email

n/a

Amy Bertram phone numbers

About Amy Bertram

Specialties: EDC experience using Medidata (RAVE), MedNet and Inform 4.6.

Amy Bertram's Current Company Details
Parexel

Parexel

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Data Management Team Lead at Parexel
Amy Bertram Work Experience Details
  • Parexel
    Data Management Team Lead
    Parexel Mar 2021 - Present
    Durham, North Carolina, Us
    Manage and coordinate the integration and utilization of all ancillary systems. Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive to resolution with cross-functional stakeholders as part of Risk Management Plan.Review and analyze metrics to derive meaningful summary of study trends.Review of the Master Services Agreement, and/or contract to manage toward sponsor-specific metric targets indicators. Host and attend cross-functional meetings. Prepare Meeting Agendas and Minutes. Prepare for and participate in study or program-level Bid Pursuit preparation meetings. Portray Parexel's technical and operational expertise and capabilities, and tailor to meet sponsor needs. Create relevant slides with cross-functional Global Data Operations input. Present with confidence and as a cohesive Parexel team with other functions.Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.Maintain inspection-ready Trial Master File. Identification of quality issues, ensuring they are raised in relevant system and closed accordingly. Prepare for and participate in audits and inspections for internal, sponsor, and regulatory agencies.Drive and implement Corrective/Preventive actions for study.Ensure appropriate project level resourcing of staff and staff assignments. Identify and request functional staff necessary for the project team. Regular review and update of DM resources to ensure alignment with contracted budget, project resource forecast, actuals, and demand, utilizing the necessary systems. Determine and resolve the root cause of DM-related project variance in a timely manner, including negotiating/raising changes in scope.Provide DM functional input, considering the impact of the initiative and the impact on DM and Parexel. Participate in creation/review of SOP process and/or templates.Deliver Project Specific Training to internal DM team. Deliver On-the-job training where needed/requested.
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  • Sdc (Statistics & Data Corporation)
    Senior Clinical Data Manger
    Sdc (Statistics & Data Corporation) Sep 2020 - Mar 2021
    Tempe, Arizona, Us
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  • Sanofi Genzyme
    Senior Clinical Data Associate
    Sanofi Genzyme Jan 2018 - Aug 2020
    Paris, France, Fr
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  • Sanofi Genzyme
    Ctom
    Sanofi Genzyme Mar 2014 - Dec 2017
    Paris, France, Fr
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  • Ocular Therapeutix, Inc.
    Manager, Clinical Data Management
    Ocular Therapeutix, Inc. Sep 2012 - Jan 2014
  • Harvard Clinical Research Institute
    Principal Data Manager
    Harvard Clinical Research Institute May 2010 - Sep 2012
  • Abt Bio-Pharma Solutions
    Senior Clinical Data Manager
    Abt Bio-Pharma Solutions Sep 2008 - Apr 2010
  • Harvard Clinical Research Institute
    Senior Clinical Data Manager
    Harvard Clinical Research Institute Aug 2006 - Sep 2008
  • Battellecro
    Senior Data Manager
    Battellecro Aug 2005 - Aug 2006
    Us
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  • Eastern Cooperative Oncology Group (Ecog)
    Clinical Data Manager
    Eastern Cooperative Oncology Group (Ecog) Jan 2005 - Jul 2005
  • Millennium Pharmaceuticals
    Senior Clinical Data Manager
    Millennium Pharmaceuticals Mar 2004 - Jan 2005
    Cambridge, Ma, Us
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  • Biogen
    Senior Clinical Data Manager
    Biogen Sep 2003 - Mar 2004
    Cambridge, Ma, Us
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  • Prometrika, Llc
    Senior Clinical Data Manager
    Prometrika, Llc Apr 2003 - Sep 2003
  • Muro Pharmaceuticals
    Senior Clinical Data Manager
    Muro Pharmaceuticals Apr 2000 - Mar 2003
  • Quintiles
    Senior Clinical Data Manager
    Quintiles Sep 1998 - Feb 2000
    Durham, North Carolina, Us
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  • Ergo Science
    Senior Clinical Data Manager
    Ergo Science Dec 1996 - Jun 1998
  • Boston Biostatistics (Now Averion)
    Senior Clinical Data Manager
    Boston Biostatistics (Now Averion) Dec 1993 - Dec 1996
  • Medical Research International
    Data Entry Specialist
    Medical Research International Feb 1990 - Sep 1993

Amy Bertram Skills

Edc Medidata Inform Clinical Data Clinical Data Management Crf Design Data Management Meddra Sop Sop Development Medical Devices Database Design Medical Coding Computer System Validation Data Validation Diabetes Biotechnology Cardiology Validation Therapeutic Areas Gcp Cro Ctms Clinical Trials Pharmaceutical Industry Clinical Development Electronic Data Capture

Amy Bertram Education Details

  • Saugus High School
    Saugus High School
    General

Frequently Asked Questions about Amy Bertram

What company does Amy Bertram work for?

Amy Bertram works for Parexel

What is Amy Bertram's role at the current company?

Amy Bertram's current role is Data Management Team Lead at Parexel.

What is Amy Bertram's email address?

Amy Bertram's email address is am****@****ofi.com

What is Amy Bertram's direct phone number?

Amy Bertram's direct phone number is +178124*****

What schools did Amy Bertram attend?

Amy Bertram attended Saugus High School.

What are some of Amy Bertram's interests?

Amy Bertram has interest in Environment, Education, Poverty Alleviation, Disaster And Humanitarian Relief, Human Rights, Health.

What skills is Amy Bertram known for?

Amy Bertram has skills like Edc, Medidata, Inform, Clinical Data, Clinical Data Management, Crf Design, Data Management, Meddra, Sop, Sop Development, Medical Devices, Database Design.

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