Senio Clinical Data Specialist, Latam

hace 4 semanas

Desde casa, México IQVIA A tiempo completo

**POSITION TITLE**: Senior Clinical Data Specialist**REPORTS TO**: Associate Manager/Manager, Data Management or Designee**BASIC FUNCTIONS**:**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- Ability to work independently**CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA**:- Very little physical effort required to perform normal job duties (unless otherwise indicated)- Travel, occasional as required for bid defenses, Investigator Meetings, or other meetings as requested, not anticipated to exceed 40hr per year.**MINIMUM RECRUITMENT STANDARDS**:- Bachelor's degree in one of the life sciences, or equivalent knowledge and experience, and- 3 years of experience in pharmaceutical industry and/or contract research organization, with 2 years in data management

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