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. We are currently looking for Principal Data Managers (Home or Office Based)

IQVIA Biotech Offers Candidates

• Intensive Onboarding Programmes
• Home-based working
• Regular line manager support and oversight ensuring good work/home life balance for proactive career development
• 1000’s of online training sessions.
• Mentorship for all new starters

BASIC FUNCTIONS:

Principal Data Manager position is to manage all data management (DM) activities for more complex, larger projects and/or program of studies from start-up through database closure and archival, producing high quality databases for analysis and potential regulatory submissions.  The Principal Data Manager also serves in a leadership role within Data Operations to train and mentor other staff in data management functions. Due to our clients requiring DM experts on their studies, this role will be a ''hands on'' position, where you will be a lead on at least one study.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Data Operations Lead of the program and/or projects
  • Data Operations lead for internal/client team meetings and communication collaborating with the project team on overall Data Operations 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
  • 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
  • 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
  • Provides and/or reviews staffing projections for DM activities for assigned program and/or projects
  • Proposes process or system improvements for global implementation and participates in development and implementation
  • Discusses roadblocks to Data Operations deliverables and potential strategies for overcoming with project team and/or Data Operations management and implements solutions
  • Represents DM in regulatory and Sponsor audits for assigned study and/or program as well as general qualification audits by Sponsors
  • Develops, Maintains and Archives DM Project Documentation
  • Represents Data Management in Proposal Process and at Bid Defense Meetings (BDM)
  • Oversees System Development and Modifications

KNOWLEDGE, SKILLS AND ABILITIES:

• Ability to lead technical and clinical team members
• 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 and take meeting minutes
• Excellent knowledge of clinical trial concepts
• Proficiency with multiple data collection systems including electronic data capture (EDC) technologies such as ePRO or eCOA, IRT (preferred EDC systems are InForm and Rave)
• Ability to develop study-specific procedures
• Ability to maintain timelines using time management tools (@Task, MS Project, etc.)
• Excellent verbal, written and listening communications skills
• Ability to learn new things, teach others, and provide and accept constructive feedback
• Ability to create and adhere to detailed instructions
• Effective logical thinking ability regarding problem-solving skills
• Proficiency in computer applications and time management tools (e.g., MS Office)

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Very little physical effort required to perform normal job duties (unless otherwise indicated)
• Occasional travel for bid defense meetings, Investigator Meetings, client face-to-face meetings, user group meetings or training courses.  Travel not anticipated to exceed 2-3 times per quarter.

MINIMUM RECRUITMENT STANDARDS:

• Bachelor’s degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification
  • 10 years of experience in clinical trials within a similar function including:
  • proven competence in managing delivery of multiple global projects / programs independently through full data management study life-cycle, including large and/or complex trials
  • experience in handling complex customer negotiations and 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