Data Acquisition Specialist

2+ years

Not Disclosed

Remote

10 March 19, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About This Role:
The Non-CRF Data Lead is responsible for overseeing the collection, quality, and timely delivery of non-CRF data across multiple clinical studies. This role requires proactive leadership in collaborating with non-CRF vendors/data providers, ensuring data transfer agreements are in place, and managing data issues. The Non-CRF Data Lead plays a key role in ensuring adherence to data management conventions and processes while working closely with the study team to mitigate risks and ensure project milestones are met. The individual will represent DSD (Data Strategy and Delivery) in study teams, ensuring that all non-CRF data deliverables align with study requirements.

Key Responsibilities:

Leadership & Communication:

Lead the collection of non-CRF data across the entire study lifecycle (set-up, conduct, and close-out) for multiple studies.
Collaborate closely with non-CRF vendors/data providers to establish data transfer agreements and ensure timely, high-quality data delivery.
Act as a key point of contact between the study team and vendors to negotiate and ensure mutual agreement on data collection and transfer needs.
Effectively communicate non-CRF data collection deliverables and status updates to the DQL (Data Quality Lead) and other study team members.
Coordinate cross-functional non-CRF tasks, ensuring alignment with downstream processes and stakeholder needs.

Process & Risk Management:

Select and implement study-specific data collection standards, conventions, and best practices for non-CRF data.
Develop and maintain study-level project plans, including contingency plans, to ensure on-time delivery of non-CRF data that supports project milestones.
Proactively identify potential risks, suggest mitigation strategies, and drive the study team to adhere to non-CRF data principles and processes.
Influence the study team to follow agreed-upon conventions and challenge where necessary to ensure data quality.

Collaboration & Development:

Represent DSD in study working groups or sub-teams, working collaboratively with the study team to develop and implement specifications and processes for non-CRF data providers.
Identify and address gaps in existing processes, and develop new guidance documents as needed.
Foster knowledge sharing and ensure that best practices for non-CRF data management are implemented across assigned studies.

Compliance & Understanding:

Demonstrate a deep understanding of the conceptual basis for data management conventions, standards, and processes.
Ensure compliance with regulatory principles and GxP requirements (SOPs, Policies, etc.).
Work closely with the study team to align data management processes with the broader drug development process, particularly with biostatistics and statistical programming.

Skills & Qualifications:

Strong Communication Skills: Able to communicate proactively and clearly with both internal and external stakeholders, managing complex interdependencies.
Data-Driven Mindset: Demonstrates curiosity for data and the ability to think critically and learn quickly.
Scientific Background: A solid foundation in medical, biological, lab, imaging, or life sciences.
Clinical Trial Experience: Proven experience in the collection and management of clinical trial data, including non-CRF data.
Risk Management: Able to identify risks early and suggest mitigation plans.
Technical Proficiency: Comfortable working across multiple platforms and tools used for data management in clinical trials.
Regulatory Knowledge: Strong understanding of compliance, regulatory principles, and GxP requirements.

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Data Acquisition Specialist

Job Description

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