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

  • Bloemfontein
  • Anywhere

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

IQVIA

Bloemfontein, BEN

http://jobs.zeleus.com/6D482B8FDCB741F386FC32064731AF3423

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

#LI-AP22

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

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