We are now looking for a professional with adequate knowledge of clinical research/development operations and strong organizational skills to work in a challenging global role based in our Data Science & Analytics team in Finland in Espoo as
SENIOR DATA ACQUISITION SPECIALIST
Your tasks and responsibilities
- Analyze the clinical protocol to ensure that all data collection requirements are identified and accounted for in the setup phase.
- Develop specifications for data elements and ensure that they are complete including programming of any study level integrations.
- Setup study level data elements using available software including programming of edits, dynamics and modifying custom functions, and derivations as required across multiple platforms.
- Assist in setup and maintenance of standardization efforts for data collection elements across different platforms as required.
- Contribute and monitor the study setup timeline in accordance with development SOPs.
- Support Study throughout the study lifecycle. That includes assessing impact of changes, implementing, and testing all the eCRF changes including any impact to integrations.
- Complete in a timely manner all documentation for study setup in compliance with the applicable SOP to be inspection ready and support audits and/or inspections of the same.
- Organize and lead a cross functional development team to setup study level data elements.
- Manage competing priorities through effective project/time management and delegation.
- Provide guidance and delegate work to external staff. Perform oversight (Quality Control) and ensure timelines are met of delegated work.
- Working collaboratively with global Data Acquisition & Integration (DA&I) colleagues to meet shared objectives, understanding different working cultures and present the results to the community.
Who you are
- Bachelor’s degree (or equivalent/higher), preferably in the fields of Natural Sciences, Life Sciences, Informatics, Medical Documentation or related subject.
- Several years of experience in study and/or project level experience as a Data Acquisition Specialist in a scientific, data-driven position in the medical research area.
- Strong organizational skills and able to collaborate with minimal supervision.
- Ability to work effectively in a global environment. Essential competencies identified include: Customer Focus, Driving Results, Planning & Alignments. Other key capabilities like Collaborating, Instilling Trust, and Managing Complexity should be also displayed by the Data Acquisition Specialist.
- Experience in leading global clinical team with effective management of activities to deliver quality study level setup is required.
- Understanding the principles of system design, database and programming for data acquisition is required.
- Experience in software testing, and other verification tasks performed at each stage of the software development life cycle is required.
- Good understanding of the drug development processes, understanding of relevant research processes is desired.
- General understanding of regulations and guidelines (e.g. ICH, GCP, European Clinical Trials Directive, Privacy rules) is desired.
- Experience in definition and setup of data acquisition elements in the clinical trials across different Therapeutic Areas and Phases of drug development is desired.
- Understanding the usage of medical data standards (i.e. sponsor specific or CDISC) in context of study is desired.
- Knowledge in routinely used technology platforms (i.e. RAVE, LSH, Oracle Clinical) for data acquisition and associated review, is desired.
- Exposure to industry standards on integration technology such as web services and odm.xml is also desired.
- The Data Acquisition Specialist is required to conduct him/herself in an appropriate business manner adhering to a high ethical standard.
We offer an interesting role in a global life science company with a chance to develop your skills further. To be considered for this exciting opportunity, please submit your application at your earliest convenience and no later than Monday August 30, 2021. Candidates will be reviewed on a continuous basis.
If you have questions about the position, you are welcome to contact Luiz Giorgiani, Head of Clinical Data Management RED II, Data Sciences & Analytics, by phone +358 400 807 868 on July 26, between 13.00-14.00 pm (EET) or on August 4, between 14.00-15.00 pm.
Functional area: Clinical Operations
Seniority level: Professional
Location: Espoo, Finland