Principal Data Manager (Home or Office based) - Iqvia Biotech at IQVIA

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