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DOCS Clinical Database Developer in Pierre, South Dakota

Clinical Database Developer

Ref #: 28495

Employment type: Permanent - Full-Time

Location: US-Remote

Posted: 16-Apr-2021


Clinical Database Developer

DOCS is currently seeking an experienced individual for a home-based Clinical Database Developer position. This position requires previous experience within a pharma/CRO setting.


The Data Acquisition Expert specialized in eSource data collection, ingestion, transformation and storage, drives the implementation of the data acquisition strategy and serves as subject matter expert for at least one of the following data acquisition capabilities;

• Collection, transfer and ingestion of electronic data from internal sponsor sources or external data providers (non-CRF)

• Collection and management of clinical data from non-site personnel, wearables and sensors (Devices & Apps)

• Collection and ingestion of data from electronic health records (EHR)

Key responsibilities

• Analyze data and content from external data streams and propose efficient pathways to integrate relevant data into clinical data repository to support analysis, reporting and submission of data.

• Liaise with key data stakeholders to understand the purpose of data collection and agree upon data availability and consumption requirements.

• Liaise with external data providers, Data Managers and Clinical Programmers to drive optimal data transfer, ingestion, transformation and storage solutions.

• Oversee the development of data transfer agreements

• Take the lead in developing data transfer agreements for new data stream types or for data streams with need for understanding complex data structures and/or content.

• Define data collection metadata for eSource data streams in a Metadata Repository; Ensure end to end oversight on full data flow; Identify downstream impact of data collection metadata deviations from standards.

• Identify and resolve issues that may negatively impact study timelines. Escalate to leadership as needed.

• Develop procedural documents, job aids and training material as part of a compliant environment

• Lead or participate in cross-functional improvement initiatives to develop an industry leading data acquisition capability.

• Keep abreast of relevant industry trends and innovative technologies related to eSource

• Actively contribute to the shaping and implementation of the Data Acquisition strategy, improving re-usability, efficiency and consistency of data acquisition tools across studies and therapeutic areas

Qualifications, skills and experience

• BS/BA degree or higher in Health Sciences or equivalent work experience is required. PhD preferred.

• Minimum of 5 years of relevant experience within the Pharmaceutical, CRO or Biotech industry is required.

• Good understanding of overall drug development process with proven expertise in clinical trial setup and execution

• Experience with collecting Safety Lab, PK, Biomarkers, ECG, eCOA/ePRO or other external data ingestion within clinical trials is preferred

• Experience with collecting data from Digital Health technologies and/or RWD are assets

• Deep expertise in specialized data streams (omics data, flow cytometry, …) is an asset

• Strong knowledge of GCP/ICH guidelines

• In dept knowledge of data collection and submission industry standards (CDASH, SDTM) is required

• Ability to work in a global setting across different cultures within a matrix environment

• Demonstrated experience in working with external data providers within a clinical study setting

• Strong project management knowledge (defining objectives and deliverables, managing a cross-functional project team, managing stakeholders, negotiating, leading with influencing)

• Excellent verbal and written communication skills

• Effectively cope with change (ability to deal with ambiguity, shift gears comfortably, decide and act without having the total picture, and handle risk and uncertainty)

• Ability to think out of the box with creative and innovative mindset

• A team player, able to motivate and empower others

• Working knowledge of industry leading eCRF tools (Rave) is preferred

• Knowledge of EHR to EDC middleware technologies (Clinical Pipe, …) or health care data exchange formats (HL7 FHIR, …) are assets

• Experience working with a clinical metadata repository and understanding of end-to-end clinical metadata concepts are assets

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.