KEY TASKS & RESPONSIBILITIES

In addition to the duties outlined, performs additional duties and responsibilities based on developing skills and capabilities:

Act as primary study contact, subject matter expert (SME) and liaison for external data and local lab processing on assigned studies for internal and external stakeholders.
Communicate to Clinical Data Manager, study team, and/or Manager, External Data problems involving local lab data point issues and validation issues.
Communicate to vendors and client issues involving external data transfers, data point issues and validation issues.
Perform QC of laboratory normal ranges prior to entry to ensure documents received are ICH/CGP compliant and accurate.
Perform Lab Normal Range data entry and/or QC, meeting processing deliverables on time and with quality.
Review study protocols and local lab and external data eCRF design in start-up, providing recommendations and insights into best approach for data aggregation and capture.
Ensure clinical database supports data requirements and is in alignment with external vendor data.
Perform QC of external data test transfers for acceptance.
Maintain data transfer agreement set-up logs, reconciliation logs and/or change logs.
Perform QC of laboratory normal ranges prior to entry to ensure documents received are ICH/CGP compliant and accurate.
Verify the normal ranges are properly linked to the patient results in the local lab data collection module of the database.
Review external vendor data and/or local laboratory data listings via elluminate and issue queries or communicate data issues to internal and/or external team members.
Review and provide input to DMP, IDROP and CCG to ensure local lab normal range and/or external data process for assigned study is accurately documented.
Perform local lab and external vendor associated study start-up and build activities.
Perform IST activities for local lab normal range population.
Develop the local lab and external data exception listing specifications and QC the output for movement to production.
Drive the set-up and implementation of external vendor data transfer agreements and specifications, working closely with the client, vendors, and functional teams.
Provide study specific local lab and/or external vendor data driven metrics to Clinical Data Management, Client and/or Project Management.
Report client and/or study level local lab and/or external vendor data driven units to Project Management for scope monitoring.
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 leads and management for developing, reviewing, and implementing processes and guidelines for external data and local lab data processing.
Support management for reporting of external data and local lab KPI s and performance metrics.
Work closely with cross-functional teams on study reporting and data trending via clinical data analytics technologies for local laboratory and/or external vendor data to proactively identify and mitigate risks.
Contribute to digital transformation in external data management, leveraging emerging technologies to streamline process, ensure compliance and stay at the forefront of industry advancements.
Utilize technology including AI ML and advanced analytics to perform real time monitoring to proactively identify and address data discrepancies, ensuring accuracy, integrity, and quality of various external and local lab data.
Facilitate external and local lab data cross-functional team training.
Other duties as assigned.

CANDIDATE S PROFILE

Education/Language:

Basic Science/Bachelor of Science degree in health-related field or an equivalent combination of education, training and directly related experience to successfully perform the key responsibilities of the job.
Medical Laboratory Technology certificate preferred.
Excellent command of the English language (both written and verbal).

Professional Skills & Experience

5+ years experience or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
Ability to maintain confidentiality of data and information during interactions with staff at all levels.
Understanding of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
Basic understanding of medical terminology
Excellent team player and collaborator
Ability to work independently and manage multiple projects.
Detail oriented, ability to multitask, with strong organizational skills.
Strong communication skills.
Knowledge of clinical data management processes and vendor data processing
Familiarity with various 3 rd party vendors and data transfers.
Understands a variety of external data types and methodologies.
Strong leadership and mentoring skills.
Considerable experience within the CRO or pharmaceutical industry.

Technical Skills & Experience

Proficiency in Microsoft Office Applications
Accurate keyboarding skills
Demonstrated computer literacy
Clinical Data Management System(s) knowledge, including Electronic Data Capture system(s)

Sr External Data Specialist