Clin Data Mgr I

Salary depends on experience
Posted on 06/21/18
Philadelphia, PA
5 - 7 years experience
Pharmaceuticals & Biotech
Salary depends on experience
Posted on 06/21/18

Job Overview

Lead Clinical Data Manager

Permanent, Salaried

Remote from anywhere in the U.S. or Canada

 

 

Responsibilities

Serve as the technical leader on all data management aspects for project(s) including stait-up, maintenance, and completion activities.

+ Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.

  • Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and

+ Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.

+ Coordinate and paiticipate i n the development of the clinical data model and/or databasedesign and annotate the CRF (eCFR) according to these specifications.

+ Review data acquisition conventions and data review guidelines I diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion

I monitoring conventions.

+ Coordinate the development and testing of data management systems edit I data validation checks) diagnostics) and special listings I procedures used as tools for the data review and discrepancy management activities.

+ Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical suppo1t, drug safety, etc.) to suppo1tthe set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handlingand quality.

  • Advanced planning and risk management for projects (issueescalation, resource management).

+ Oversee the technical pe1formance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.

+   Assist with goal creation and performance review assessment for data review project staff.

+ Maintain technical data management competencies via pa1ticipation in internal and external training seminars.

+ Ensureproject staff are trained and adhere to project-specific, global, standardized data management processes.

+ Identify areas for process and efficiency improvement and implement solutions on assigned projects.

+ Support achievement of project revenue and operating marginfor data management activities to agreed targets.

 

Experience

University/collegedegree(life science, pharmacy or related subject preferred), or certification

  • in a related allied healthprofession from an appropriately accredited institution (e.g., nursingce11ification, medical or laboratory technology).
  • Additional relevant work experiencewill be considered in lieu of formal qualifications.
  • Broad knowledge of drug development processes.
  • Understanding of global clinicaldevelopment budgets and relationship to productivity targets.
  • Knowledge of effective clinicaldata management practices.
  • Knowledge oftime and cost estimate development and pricing strategies.
  • Thorough knowledge of TCH Guidelines and GCP including international regulatoryrequirements for the conduct of clinical development programs,especially as related to datahandling and processing.

Education/Qualifications

Minimum five (5) years relevant workexperiencein data managementwith approximatelyone (1) yeartechnicalsupervisoryexperiencetoinclude data management,clinicaloperations, and knowledgeof severaltherapeuticareas.

  • Demonstrated skill fortechnicalmanagement of staff exceeding 5 employees.
  • Financialmanagementof gross revenuesin excess of $250K per
  • Excellentoraland writtencommunication and presentation skills.
  • In depthknowledge of clinicaltrialprocess and datamanagement,clinicaloperations,biometrics,qualitymanagement,andsystemsapplications to supportoperation
  • Workingknowledgeof the relationship and regulatoryobligationof the CROindustry withpharmaceuticalI biotechnologica 
    • Ability to lead by example teams on project strategies and achievement of depa11ment goals,objectives, and initiatives and to encourage team members to seek solutions.
    • Demonstrated managerialand interpersonal skills

Education/Qualifications

Minimum five (5) years relevant workexperiencein data managementwith approximatelyone (1) yeartechnicalsupervisoryexperiencetoinclude data management,clinicaloperations, and knowledgeof severaltherapeuticareas.

  • Demonstrated skill fortechnicalmanagement of staff exceeding 5 employees.
  • Financialmanagementof gross revenuesin excess of $250K per
  • Excellentoraland writtencommunication and presentation skills.
  • In depthknowledge of clinicaltrialprocess and datamanagement,clinicaloperations,biometrics,qualitymanagement,andsystemsapplications to supportoperation
  • Workingknowledgeof the relationship and regulatoryobligationof the CROindustry withpharmaceuticalI biotechnological

 

 

 

    • Ability to lead by example teams on project strategies and achievement of depa11ment goals,objectives, and initiatives and to encourage team members to seek solutions.
    • Demonstrated managerialand interpersonal skills
    •  

Experience

    • University/collegedegree(life science, pharmacy or related subject preferred), or certification
    • in a related allied healthprofession from an appropriately accredited institution (e.g., nursingce11ification, medical or laboratory technology).
    • Additional relevant work experiencewill be considered in lieu of formal qualifications.
    • Broad knowledge of drug development processes.
    • Understanding of global clinicaldevelopment budgets and relationship to productivity targets.
    • Knowledge of effective clinicaldata management practices.
    • Knowledge oftime and cost estimate development and pricing strategies.
    • Thorough knowledge of TCH Guidelines and GCP including international regulatoryrequirements for the conduct of clinical development programs,especially as related to datahandling and processing.

Job Number 2018-20901

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