Senior Lead Clinical Data Manager - Iqvia Biotech at IQVIA

BASIC FUNCTIONS:
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 including but not limited to:

1. Discrepancy management
2. Data Reconciliation (e.g., Vendor, SAE) including coordination of transfers and issue resolution with other functional areas and/or 3rd party vendors
3. Investigation and remediation of reviewer-reported data issues such as from statistical, medical or Sponsor reviews

• Assumes ownership for DM project deliverables within DM scope of services including overseeing overall quality, adherence to Study Plans and standard operating procedures, coordinating with manager for resourcing requirements

Oversees System Development and Modifications:

• Implements DM strategy on the project/program based on scope of services and as laid out by DM management
• Coordinates with Technical Design and Clinical Programming team as well as Project Management to develop and maintain DM startup timelines including the development, testing and implementation of all data capture tools
• Coordinates with vendors and cross-functional teams to assure timely completion of tasks to meet established timelines
• Coordinates with the Technical Design and Clinical Programming team and/or 3rd party vendor to develop and test the CRF and edit check specifications as well as custom EDC reports to support protocol requirements
• Coordinates with the EDC programmers and/or 3rd party vendors in the setup and testing of electronic data capture (EDC) technologies such as Interactive Response Technology (IRT), electronic patient reported outcomes (ePRO), and electronic clinical reported outcomes (eCOA) as required per the scope of work.
• Facilitates project team and Sponsor reviews of system documents including but not limited to Time and Events Schedule, CRFs, Edit Checks, revision specifications
• Consolidates reviewer comments from internal team/sponsor and collaborates with the project and Clinical Programming team, as required, for revisions
• Coordinates with the project team as well as the Technical Design and Clinical programming team to manage post go-live EDC modifications assuring effective implementation (including consistency across program when applicable) and team communication for program and/or projects

Oversees System and Data Listing Testing Activities:

• Coordinates testing activities for the EDC technologies per scope of services
• Performs testing for EDC systems as required per scope of services and standard operating procedures
• Verifies reports created in EDC or other ad hoc reporting tool like J-Review, BOXI and associated change control requests
• Provides feedback to the other project team members and managers to improve the deliverables.

Develops, Maintains and Archives DM Project Documentation including:

• Data Management Plan, Data Review Plan, CRF Completion Guidelines. and other study-specific plans as required
• Data review listing specifications
• Database Design Documents, Edit Specifications, Reconciliation guidelines, and Report specifications
• Database lock documentation

Represents Data Management at Bid Defense Meetings (BDM)

• Prepares project-specific slide presentation from DM template functional slides
• Participates in BDM preparation meetings including discussing overall DM strategy
• Presents DM slides at BDM and constructively participates in discussion

Continuous Improvement

• Recommends and assists in the development of standards and/or improvements to existing standards including processes, CRFs, data listing reports and document templates
• Serves as Data Operations mentor
• Creates and maintain documentation for templates (DMP, CRF Completion guidelines, Database Design Documents, Edit specifications, Reconciliation guidelines, Report specifications)
• Trains others on specific departmental processes including database design document creation, edit check creation, change control processes, database lock
• Provides open environment for question/issues about DM topics from within department and cross-functionally

KNOWLEDGE, SKILLS AND ABILITIES:

• Team player with ability to learn new skills, tasks and technologies and teach others
• 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
• Excellent verbal, written and listening communications skills
• Effective interpersonal skills including ability to provide and accept constructive feedback
• Effective logical thinking ability regarding problem-solving skills
• Proficiency in computer applications and time management tools (e.g., MS Office)