Sr Clinical Data Specialist

hace 2 semanas

San José, Costa Rica Fortrea A tiempo completo

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Job Overview:
Serve as a member of the project team with primary responsibility for clinical data review, query generation / resolution and reconciliation to support the delivery of clinical data according to client quality and integrity specifications, and project timelines and productivity targets. Potential to assist in development of project Data Management Plan, including data review guidelines / set-up of the data management systems according to project requirements. May support Lead Data Manager (LDM) with the review, maintenance, and update of external vendor data received from central vendor or local laboratories.

Summary of Responsibilities:

- Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.
- Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
- Generate, resolve and track queries to address problematic data identified during data review activities.
- Perform aggregate review of clinical data by patient, site and / or project to identify data trends (patient safety, compliance, etc.) and / or data inconsistencies that require further investigation.
- Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRF Completion guidelines, Data Management Plans, Perform Data review utilizing all applicable documents such as protocols, CRFs (or eCRFs and eDiary) etc.
- Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
- Assist in the review of the database design and annotate the CRF (eCRF) according to the specifications.
- Create and assist in the data review guidelines, make sure to be consistent with the clinical data model, and CRF/eCRF completion / monitoring conventions.
- Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
- Ensures service and quality, meet agreed upon specifications per the DMP and scope of work in the budget.
- Performs other related duties as assigned by management.

Qualifications (Minimum Required):
Experience (Minimum Required):

- 1-3 years working on Clinical Data Management or working with Clinical Trial protocols.
- Time management skill and ability to adhere to project productivity metrics and timelines.
- Ability to work in a team environment and collaborate with peers.
- Good organizational ability, communication, and interpersonal skills.
- Team working skills and good collaborator skills.
- Knowledge of medical terminology is preferred.
- Knowledge of science or a scientific background is preferred.
- Good oral and written communication skills.

Preferred Qualifications Include:

- Two or more years of Electronic Data Capture experience.
- Knowledge of Fortrea and the overall structure of the organization.

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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