External Data Specialist

External Data Specialist

W2 Contract

Pay Rate: $55 - $65 per hour

Location: Redwood City, CA - Hybrid Role

Job Summary:

The External Data Specialist is responsible for managing the processing of external and/or local lab data received throughout the clinical trial lifecycle. The External Data Specialist will be handling various external data sources (i.e., local labs, imaging, EKG, PK, etc.) to internal cross-functional teams and external stakeholders to ensure high-quality data. The External Data Specialist works to ensure departmental SOPs, guidelines, regulatory, and global standards are followed to maintain data integrity and ensure consistency across all assigned projects.

Duties and Responsibilities:

• Act as a liaison for external data and local lab processing on assigned studies for internal and external stakeholders.
• Review study protocols and local lab and external data eCRF design in start-up, providing recommendations and insights into the best approach for data collection and capture.
• Work with Safety and/or Pharmavigilance on Serious AE reconciliation according to SOPs and guidelines, as applicable.
• Provides DM support to Statisticians and Statistical Programmers in the production of clinical trial reports and other deliverables.
• Perform local lab and external vendor-associated study start-up and build activities.
• Ensure the clinical database supports data requirements and is aligned with external vendor data.
• Work with the vendors and functional teams on the setup and implementation of external vendor data transfer agreements and specifications.
• Perform QC of external data test transfers for acceptance.
• Communicate with internal/external study team members and Lead DM problems involving local lab data point issues and validation issues.
• Communicate with the DM vendors and CRO issues involving external data transfers, data point issues, and validation issues.
• Communicate with the Lab Administrator regarding Lab Normal Range data entry issues and/or missing ranges; identify the root causes and provide solutions.
• Review and/or QC of laboratory normal ranges prior to ensuring documents received are compliant and accurate.
• Maintain data transfer agreement, reconciliation trackers/or issues logs.
• Review external vendor data and/or local laboratory data listings and issue queries or communicate data issues to internal and/or external team members.
• Review and provide input to DMP and CCG to ensure the local lab normal range and/or external data process for the assigned study is accurately documented.
• Provide study-specific local lab, external vendor data-driven metrics, and SAE reconciliation issues to internal and external study team members as needed.
• Attend internal and external study team calls, as needed, for support of study-specific local lab and external vendor data processes.
• Identify and recommend process improvements, working with functional team members and management for developing, reviewing, and implementing processes and guidelines for external data, local lab data, and SAE reconciliation processes.
• Support management for reporting of external data and local lab KPI's and performance metrics.
• Work with cross-functional teams on study reporting and data trending for local laboratories and/or external vendor data to proactively identify and mitigate risks.
• Facilitate external and local lab data cross-functional team training.
• Contributes to a professional working environment through exemplifying our Core Values.

Requirements and Qualifications:

• Bachelor's degree or an equivalent combination of education, training, and directly related experience to successfully perform the key responsibilities of the job.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.
• Ability to handle multiple project tasks and prioritize effectively.
• Well organized and detail-oriented.
• Proven ability to work both independently and in a team setting.

Preferred Qualifications:

• Bachelor's degree in health sciences, Life Sciences, or a health-related field.
• CRO/service provider experience desired.
• Knowledge of industry standards (CDISC, SDTM, CDASH).

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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