Senior Clinical Data Specialist/Associate Lead Data Manager (Home or Office based) - IQVIA Biotech at IQVIA

About the job

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 are in is cutting edge for therapies with un-met medical need.

BASIC FUNCTIONS:

Senior Clinical Data Specialist position is to ensure a quality database per industry standards and client specifications, while being a leader within the department as a subject matter expert for a system and/or process.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Clinical Data and Query Review:

• Create listings using ad hoc query tools
• Issue queries and review query responses with the highest level of quality based upon the Data Review Plan, Manual Review (Tumor Response, AE/CM compares), and Reconciliation (Laboratory, SAE, ECG, and other vendors)
• Assist other data reviews for Biostatistics, Medical Review, Client, and other ad hoc reports

Oversees System Development:

• Create or draft CRF design, edit check specification and DM listings
• Consolidate comments from internal/sponsor for discussion and approval
• Ensure all non-DM activities related to database development are completed in a timely manner

Subject matter expert for DM product or process:

• Create and Update SOPs/WP related to the product or process
• Provide training for DM and other staff members on process and/or product implementation
• Consult with DM leads or other team members on implementation and best practices
• Participate in user group meetings as the IQVIA Biotech representative

Study Management:

• May serve as Lead DM or Back-up DM lead
• Produce and Review Metric reports for internal/external project team
• Provide feedback to improve the system or reports
• Discuss roadblocks for getting processes done in a timely manner
• Review project budgets and staffing projections for data management activities
• Provide the DM lead or PM with status updates on tasks that are assigned
• Assist with the on the job training of DM staff for the study

KNOWLEDGE, SKILLS AND ABILITIES:

• Team player with ability to work well with technical and clinical team members
• Ability to collaborate with entire clinical team (CRAs, Safety, Bios, etc.)
• Excellent knowledge of clinical data concepts including knowledge of unique data collection concepts (RECIST, CDISC/CDASH, Labs, Adjudication, etc.)
• Ability to adhere to and create detailed DM study instructions and documents (CRF guidelines, Trial Design Document, edit check specifications, etc.)
• Ability to perform research for data collection and protocol specific topics
• Proficiency with multiple DBMS processing systems (preferred systems are InForm and Rave)
• Organized and thorough with attention to details
• Effective Interpersonal skills and excellent communications skills, verbal, written and listening
• Ability to learn new things, teach others, and accept constructive criticism
• Effective logical thinking ability regarding Problem-solving skills
• Proficiency in computer applications (Windows, Excel, Word, Outlook etc.)
• Ability to work independently