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Director, Clinical Data Management

Pasadena, CA, USA | Planet Pharma

  • Industry:
    HR / Recruitment Services
  • Position Type:
  • Functions:
    General Management
  • Experience:
    10-12 years
Job Description:
86 people have viewed this job

The Position:


Seeking an experienced clinical data management leader to join the clinical development team.The Director of Data Management is responsible for providing expertise and operational leadership of the clinical data management (CDM) function of CDM activities for all clinical trials.  


Responsibilities


Serve as the interdepartmental subject matter expert for the CDM area to enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision-making, regulatory approval and market acceptance;

Evaluate, recommend, implement and lead processes, infrastructure development and staffing to build Arrowhead’s CDM function for its growing clinical pipeline, including electronic data capture, external data integration, ad-hoc analysis and end-to-end data standards;

Interface with internal stakeholders including regulatory affairs, program management, and R&D to assess and meet data management needs; represent CDM function in project team activities and meetings;

Manage interface with CROs, clinical sites and laboratories to ensure the efficient and timely collection of clinical data;

Oversee identifying, locating, evaluating and validating CDM documents and databases required for report generation or regulatory submission;

Generate data listings or other data review tools for reporting of study metrics;

Evaluate and select CDM vendors; lead vendor activities for clinical trial data collection to ensure quality and timely deployment;

Support clinical study report creation with input to the data quality assurance section as well as provisioning of sample and completed eCRFs, etc;

Ensure compliance from a CDM perspective regarding protocols, SOPs and overall clinical objectives; develops SOP as needed;

Other related duties, as assigned.

Requirements:


Bachelor’s degree or Master’s degree in a related field

6+ years of supervisory and management experience

10+ years of clinical data management experience

Strong understanding of the clinical data management process including CDASH and SDTM data formats, and familiarity with physiology, pharmacology, clinical study objectives and methodologies.

Excellent understanding of the clinical trial database life cycle including CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures

Expert knowledge of industry leading eCRF tools

Good understanding of database and dictionary structures (e.g., MedDRA)

Good Clinical Data Management Practices (GCDMP) understanding

Good Clinical Practices ICH GCP guidelines understanding

Ability to travel domestically and internationally up to 10%

Preferred:


Certified Clinical Data Manager (CCDM)

Experience managing contract and/or permanent CDM staff members

Project management experience in a team setting within the biotech/pharmaceutical industry

Global trial expertise

SAS and PL/SQL, as well as other relevant programs

Demonstrated experience preparing and managing project budgets and timeline

Experienced in a senior clinical data management role within a CRO

Location: Pasadena, CA


Experience: Senior Manager/Supervisor


The Position:


Seeking an experienced clinical data management leader to join the clinical development team.The Director of Data Management is responsible for providing expertise and operational leadership of the clinical data management (CDM) function of CDM activities for all clinical trials.  


Responsibilities


Serve as the interdepartmental subject matter expert for the CDM area to enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision-making, regulatory approval and market acceptance;

Evaluate, recommend, implement and lead processes, infrastructure development and staffing to build Arrowhead’s CDM function for its growing clinical pipeline, including electronic data capture, external data integration, ad-hoc analysis and end-to-end data standards;

Interface with internal stakeholders including regulatory affairs, program management, and R&D to assess and meet data management needs; represent CDM function in project team activities and meetings;

Manage interface with CROs, clinical sites and laboratories to ensure the efficient and timely collection of clinical data;

Oversee identifying, locating, evaluating and validating CDM documents and databases required for report generation or regulatory submission;

Generate data listings or other data review tools for reporting of study metrics;

Evaluate and select CDM vendors; lead vendor activities for clinical trial data collection to ensure quality and timely deployment;

Support clinical study report creation with input to the data quality assurance section as well as provisioning of sample and completed eCRFs, etc;

Ensure compliance from a CDM perspective regarding protocols, SOPs and overall clinical objectives; develops SOP as needed;

Other related duties, as assigned.

Requirements:


Bachelor’s degree or Master’s degree in a related field

6+ years of supervisory and management experience

10+ years of clinical data management experience

Strong understanding of the clinical data management process including CDASH and SDTM data formats, and familiarity with physiology, pharmacology, clinical study objectives and methodologies.

Excellent understanding of the clinical trial database life cycle including CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures

Expert knowledge of industry leading eCRF tools

Good understanding of database and dictionary structures (e.g., MedDRA)

Good Clinical Data Management Practices (GCDMP) understanding

Good Clinical Practices ICH GCP guidelines understanding

Ability to travel domestically and internationally up to 10%

Preferred:


Certified Clinical Data Manager (CCDM)

Experience managing contract and/or permanent CDM staff members

Project management experience in a team setting within the biotech/pharmaceutical industry

Global trial expertise

SAS and PL/SQL, as well as other relevant programs

Demonstrated experience preparing and managing project budgets and timeline

Experienced in a senior clinical data management role within a CRO


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