Senior Clinical Data Specialist, Latam

hace 1 semana

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

**CLASSIFICATION**:
This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

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