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Lead/Senior Lead Clinical Data Management - IQVIA Biotech - Remote (Europe)

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Primary Location: Dublin, Dublin, Ireland Additonal Locations: Amsterdam, Netherlands,NLD; Athens, Greece,GRC; Barcelona, Spain,ESP; Belgrade, Serbia,SRB; Bloemfontein, South Africa,ZAF; Bratislava, Slovakia,SVK; Bucharest, Romania,ROU; Budapest, Hungary,HUN; Copenhagen, Denmark,DNK; Espoo, Finland,FIN; Frankfurt, Germany,DEU; Kaunas, Lithuania,LTU; Livingston, United Kingdom,GBR; Ljubljana, Slovenia,SVN; London, United Kingdom,GBR; Madrid, Spain,ESP; Milan, Italy,ITA; Oeiras, Portugal,PRT; Oslo, Norway,NOR; Prague, Czech Republic,CZE; Reading, United Kingdom,GBR; Rome, Italy,ITA; Sofia, Bulgaria,BGR; Solna, Sweden,SWE; Stevenage, United Kingdom,GBR; Strasbourg, France,FRA; Tartu, Estonia,EST; Vienna, Austria,AUT; Warsaw, Poland,POL; Zagreb, Croatia,HRV; Zaventem, Belgium,BEL Full time R1335849

Job description

IQVIA Biotech is a unique division specialising in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced working environment. The sector we work in is cutting edge with therapies for un-met medical need

BASIC FUNCTIONS:

Lead/Senior Lead Clinical Data Manager position is to manage all data management (DM) tasks to include more complex and/or larger studies and/or a program of studies from start-up through database closure and archival producing high-quality databases for analysis and potential regulatory submissions.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Manages DM-related aspects of the program and/or project
  • Collaborates with the project team on overall data management strategy for the program and/or projects, assuring overall quality and efficiency
  • Represent DM as the functional lead at internal and sponsor project team meetings
  • Provides proactive, timely communication of project status, data trends and issue resolution with internal team and Sponsor
  • Develops, generates and analyzes project progress and/or metric reports, reporting summary of findings and remediation activities, as required, to DM management, project team and Sponsor
  • Assumes ownership for DM project deliverables within DM scope of services including creation and management of DM-specific timelines and providing resource and budget projections
  • Discusses roadblocks to DM deliverables and potential strategies for overcoming with project team and/or DM management and implements solutions
  • Performs peer reviews of key DM study documents or other DM deliverables to assure quality of content and, where appropriate, consistency across a program of studies
  • Reviews and provides DM staffing projections for program and/or projects
  • Presents EDC and/or CRF completion at Investigator Meetings
  • Participates in regulatory and Sponsor audits for program and/or projects
  • Oversees daily team member activities
  • Serves as a Data Management team leader
  • Reviews DM team member activities and deliverables to ensure plans and processes are followed
  • Assures project activities are performed within budget and according to expected timelines and meet high quality standards.
  • Reviews resource allocation with the assigned DM project leads to ensure projects and budgets are managed effectively
  • Provides training of DM staff on project specific processes
  • Oversees the DM project and/or program team and performs DM tasks, as required, based on the approved Data Management and Data Review Plans
  • Oversees System Development and Modifications
  • Oversees System and Data Listing Testing Activities
  • Develops, Maintains and Archives DM Project Documentation
  • Represents Data Management at Bid Defense Meetings (BDM)
  • Continuous improvement

KNOWLEDGE, SKILLS AND ABILITIES:

  • Ability to collaborate and strategize with both technical and clinical team members (CRAs, Safety, Biostatistics, etc)
  • Ability to effectively communicate technical issues to non-DM team members and Sponsor
  • Ability to maintain positive and open relations with internal, sponsor, and vendor team members
  • Ability to facilitate team meetings ensuring accurate attendees and take meeting minutes
  • Ability to develop study-specific procedures
  • Knowledge of clinical trials concepts
  • Ability to create detailed DM project instructions and documents (CRF Completion Guidelines, Database design documents, edit check specifications, Data Review Plan, etc.)
  • Proficiency with multiple clinical EDC systems (preferred systems are InForm and Rave)
  • Proficiency with IQVIA Biotech SOPs, WPs
  • Efficient with organizational skills to meet established timelines
  • Organized and thorough with attention to details
  • Proficiency in computer applications and time management tools (e.g., MS Office)

MINIMUM RECRUITMENT STANDARDS:

  • Bachelor’s degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification
  • 7 years of experience in clinical trials within a similar function, including:
    • proven competence in managing delivery of multiple projects / programs independently through full data management study life-cycle
    • Proven Lead experience
    • experience in handling bid defense meetings
  • Equivalent combination of education, training and experience

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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

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