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Associate Director, Data Management

Job Description

The Associate Director, Data Management will oversee the data management of clinical trials in a particular therapeutic area or development program. S/he may also lead critical studies in this area of responsibility. S/he will provide oversight to the daily operations of Jazz Pharmaceuticals’ clinical programs through vendors. S/he may lead a team of data management professionals and will be expected to provide vision, leadership, and mentoring to their assigned team. S/he will facilitate effective internal and external relationships. S/he will be expected to contribute extensively to the development and growth of the Data Management group within the Clinical Operations structure.

Job Requirements

  • Oversee (and sometimes lead) the data management of Phase 1 through 4 clinical trials in a particular therapeutic area or development program
  • Develop and implement methods to demonstrate oversight of CROs and other vendors
  • Provide direction and leadership in CRO and vendor selection and management.
  • Provide technical expertise for the development of data management and other clinical trial documents (Data Management Plans and associated documents, Protocols, Centralized Monitoring Plans, etc.) and trial conduct
  • Be responsible for and manage data management activity of Clinical Data Managers assigned to his/her trials
  • Ensure that the Data Management component of the TMF and other documentation required to support regulatory submissions and inspections are maintained to the standard required
  • Coordinate closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management and Regulatory to ensure operational excellence.
  • Contribute to strategic planning to ensure optimized use of data management resources within the area of responsibility
  • Provide vision, leadership, and mentoring to staff assigned to his/her line management
  • Participate in and/or lead the development and implementation of standards and processes related to both clinical data and risk-based trial management
  • Participate in the generation and approval of budgets and timelines 

Required Knowledge, Skills, and Abilities

  • Thorough knowledge of data management and its role in the drug development process
  • Understanding of the contributions of other functions critical to the execution of clinical trials, and their interactions with data management
  • Experience of all stages of a clinical trial and vendor oversight
  • Experience of managing and mentoring clinical data managers
  • Demonstrated knowledge of ICH/GCP guidelines as they relate to data management
  • Thorough understanding of CDISC CDASH and SDTM standards
  • Extensive experience managing CROs and other data vendors.
  • Experience working with a globally distributed team
  • Ability to work on and solve complex problems.
  • Ability to prioritize and handle multiple tasks simultaneously.
  • Effective leadership skills and proven ability to foster team productivity and cohesiveness.
  • Excellent communication/interaction skills and experience in a dynamic and growing organization.
  • Travel Required 

Required/Preferred Education and Licenses

  • BA/BS, preferably in the scientific/healthcare field.
  • At least ten years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
  • Several years of study lead and supervisory experience
  • For Hematology/Oncology, experience working with collaborative oncology groups 

Description of Physical Demands

  • Occasional mobility within office environment.
  • Routinely sitting for extended periods of time.
  • Constantly operating a computer, printer, telephone and other similar office machinery. 

Description of Work Environment

  • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
  • Frequent computer use at workstation.
  • May move from one work location to another occasionally.
  • Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
  • Occasional public contact requiring appropriate business apparel.

Job Snapshot

Location US-PA-Philadelphia
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type
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Company Overview

Jazz Pharmaceuticals

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing, and commercializing meaningful products that address unmet medical needs. We have a diverse portfolio of products and product candidates, with a focus in the areas of sleep and hematology/oncology. We also support commercial products in other therapeutic areas where we can meaningfully address serious medical needs. As part of our unwavering commitment to improve patients’ lives, we are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise. We do this through a growth strategy of growing sales of the existing medicines in our portfolio; acquiring commercial products or product candidates that are in late-stage development; and pursuing focused development of our pipeline of differentiated therapies. Learn More

Contact Information

US-PA-Philadelphia
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Snapshot
Jazz Pharmaceuticals
Company:
US-PA-Philadelphia
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Store Type:

Job Description

The Associate Director, Data Management will oversee the data management of clinical trials in a particular therapeutic area or development program. S/he may also lead critical studies in this area of responsibility. S/he will provide oversight to the daily operations of Jazz Pharmaceuticals’ clinical programs through vendors. S/he may lead a team of data management professionals and will be expected to provide vision, leadership, and mentoring to their assigned team. S/he will facilitate effective internal and external relationships. S/he will be expected to contribute extensively to the development and growth of the Data Management group within the Clinical Operations structure.

Job Requirements

  • Oversee (and sometimes lead) the data management of Phase 1 through 4 clinical trials in a particular therapeutic area or development program
  • Develop and implement methods to demonstrate oversight of CROs and other vendors
  • Provide direction and leadership in CRO and vendor selection and management.
  • Provide technical expertise for the development of data management and other clinical trial documents (Data Management Plans and associated documents, Protocols, Centralized Monitoring Plans, etc.) and trial conduct
  • Be responsible for and manage data management activity of Clinical Data Managers assigned to his/her trials
  • Ensure that the Data Management component of the TMF and other documentation required to support regulatory submissions and inspections are maintained to the standard required
  • Coordinate closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management and Regulatory to ensure operational excellence.
  • Contribute to strategic planning to ensure optimized use of data management resources within the area of responsibility
  • Provide vision, leadership, and mentoring to staff assigned to his/her line management
  • Participate in and/or lead the development and implementation of standards and processes related to both clinical data and risk-based trial management
  • Participate in the generation and approval of budgets and timelines 

Required Knowledge, Skills, and Abilities

  • Thorough knowledge of data management and its role in the drug development process
  • Understanding of the contributions of other functions critical to the execution of clinical trials, and their interactions with data management
  • Experience of all stages of a clinical trial and vendor oversight
  • Experience of managing and mentoring clinical data managers
  • Demonstrated knowledge of ICH/GCP guidelines as they relate to data management
  • Thorough understanding of CDISC CDASH and SDTM standards
  • Extensive experience managing CROs and other data vendors.
  • Experience working with a globally distributed team
  • Ability to work on and solve complex problems.
  • Ability to prioritize and handle multiple tasks simultaneously.
  • Effective leadership skills and proven ability to foster team productivity and cohesiveness.
  • Excellent communication/interaction skills and experience in a dynamic and growing organization.
  • Travel Required 

Required/Preferred Education and Licenses

  • BA/BS, preferably in the scientific/healthcare field.
  • At least ten years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
  • Several years of study lead and supervisory experience
  • For Hematology/Oncology, experience working with collaborative oncology groups 

Description of Physical Demands

  • Occasional mobility within office environment.
  • Routinely sitting for extended periods of time.
  • Constantly operating a computer, printer, telephone and other similar office machinery. 

Description of Work Environment

  • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
  • Frequent computer use at workstation.
  • May move from one work location to another occasionally.
  • Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
  • Occasional public contact requiring appropriate business apparel.

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