POSITION TITLE:      Senior Lead Clinical Data Manager

IQVIA Biotech has an exciting position within its new EU based Data Management Team. The team is well established in the US and Asia but we are starting a group in Europe due to our continued growth. We are looking for someone based anywhere in the EU as the position is homebased.

We're looking for a lively, enthusiastic and independent professional who is willing to work from home with an international global team. IQVIA Biotech specialise in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, face-paced work environment. You’ll be working with a lot of the new innovative and upcoming research groups across a variety of therapy areas.

BASIC FUNCTIONS:

Senior Lead Clinical Data Manager position is to manage all data management tasks for a program of studies from study start-up to database lock, to produce a clean and analyzable database.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Manages DM Projects/Programs
  • DM lead for internal/client team meetings and communication
  • Provides Metric reports for internal/external project teams
  • Provides staffing projections for DM activities for studies
  • Implements process or system improvements for global implementation
  • Ownership for project deliverables within Data Management scope of services
  • Discusses roadblocks with PM & principal for completing study objectives in a timely manner
  • Reviews project budgets and staffing projections for data operation activities
  • Provides training of other DM staff on project specific processes
• Clinical Data and Query Review:
  • Creates Data Review Plan for studies and develops standards for the Department
  • Creates listings using ad hoc query tools
  • Oversees the issuing of queries and review query responses with the highest level of quality based upon the Data Review Plan
• Oversees System Development and Modifications:
  • Drafts the CRF design, edit check specification and DM listings
  • Facilitates clinical team review of system (eCRFs, Edit Checks, and Data Review Plan, etc.)
  • Documents comments from internal team and sponsors for discussion and approval
  • Ensures all non-DM activities related to database development are completed in a timely manner
  • Ensures all database modifications are communicated with team and implemented effectively
• Validation Creation
  • Oversees the entry of data in the Development or Quality Control systems used for validation.
  • Assists with the validation of CRF system (CRF content & edit checks), Reports using EDC Reporting and/or J-Review, and associated change control.
  • Provides feedback to other project team members and managers to improve the deliverables.
• Creates and Maintains Documentation for studies/programs/departmental standards:
  • DMP (along with supporting DM documents), CRF Completion guidelines, Trial Design Document, Edit specifications, Reconciliation guidelines, Report specifications
  • Project Specific SOPs/WPs (as directed by PM) or Department Forms/Templates for SOPs/WPs

KNOWLEDGE, SKILLS AND ABILITIES

• Ability to lead DM team members and work well with technical and clinical team members
• Ability to collaborate with entire clinical team (CRAs, Safety, Biostatisticians, etc) and answer questions related to specific data collection concerns
• 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
• Excellent knowledge of clinical trials data processing concepts
• Ability to perform research for data collection and protocol specific topics
• Proficiency with multiple DBMS processing systems (preferred systems are InForm and Rave)
• Proficiency with Novella SOPs and WPs
• Organized and thorough with attention to details
• Effective Interpersonal skills and excellent communications skills, verbal, written and listening
• Ability to learn new things and teach others
• Ability to accept constructive criticism
• Effective logical thinking ability in regards to Problem-solving skills
• Proficiency in computer programs or time management tools (Excel, Word, @Task, MSProject, etc.)

MINIMUM RECRUITMENT STANDARDS:

• Bachelor's degree in one of the life sciences, or equivalent knowledge and experience, and
• 7 years of experience in pharmaceutical industry and/or contract research organization, with 5 years in data management, and
• 2 years as a Lead Data Manager.