Iberia MKT & Trade Specialist

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Data Acquisition Specialist

Purpose :

• The Principal Data Acquisition Specialist implements data collection requirements into validated data collection instruments based on the Clinical Study Protocol and Medical Standards in collaboration with the study team, ensuring study timelines and quality requirements are met.
• The Principal Data Acquisition Specialist will lead the acquisition processes during study build and conduct, guiding the study team to ensure system functionality meets their requirements, including integrations into other systems (IxRS, eCOA, EHR etc.).
• The Principal Data Acquisition Specialist will contribute to impact and risk assessment of data flows from source to operational data models in collaboration with a cross-functional team.
• The Principal Data Acquisition Specialist ensures that study data acquisition setup activities are tested and documented according to applicable SOPs and supports applicable audits and inspections.
• The Principal Data Acquisition Specialist will contribute to cross-functional projects to enhance their working environment.
• The Principal Data Acquisition Specialist will handle complex assignments and coordinate competing priorities.

Scope (global, regional or local) : Global

Key Tasks :

• Serves as the key subject matter expert on topics related to data acquisition activities including specific activities and processes in clinical development phases.
• Mentoring junior and external staff.
• Training team members.
• Leading or contributing to expert working groups (e.g., QSD initiatives).
• Presenting best practices at internal and external industry meetings / congresses.
• Analyzing the clinical protocol to ensure that all data collection requirements are identified and accounted for in the setup phase.
• Developing specifications for data elements and ensuring that they are complete including programming of any study level integrations.
• Setting up study level data elements using available software including programming of edits, dynamics and modifying custom functions, and derivations as required across multiple platforms.
• Assisting in setup and maintenance of standardization efforts for data collection elements across different platforms as required.
• Contributing and monitoring the study setup timeline in accordance with development SOPs.
• Supporting Study throughout the study lifecycle that includes assessing impact of changes, implementing and testing all the eCRF changes including any impact to integrations.
• Completing 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.
• Organizing and leading a cross-functional development team to set up study level data elements.
• Managing competing priorities through effective project / time management and delegation.
• Proactively identifying gaps or improvements in systems / tools and processes.
• Leading functional initiatives and / or representing function in broad cross-functional initiatives and projects.
• Developing robust solutions by reaching out to necessary stakeholders and having the priorities of different stakeholders in mind.
• Presenting results regularly to a broader audience, like department / functional knowledge sharing forums and leadership teams.
• Being a change ambassador by willing to be in the forefront of change and champion new technologies and processes.
• Coaching and mentoring junior colleagues and serving as subject matter experts to peers on one or more topics.
• Providing guidance, direction and delegating work to external staff. Performing oversight (Quality Control) and ensuring 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.
• Performing other duties as assigned and ensuring Compliance.

Performs duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards.

Value added to the success of the company : DA&I provides services that encompass the full spectrum of data acquisition for clinical trials Phase 1 – 4 covering data collected from Investigator sites, ePRO / eCOA and Vendors. The DA&I responsibilities extend beyond the scope of data acquisition to data delivery and review and even further to regulatory submission and dossiers. The data acquisition activities demand the rigor of standardization and well-defined technical infrastructure to deliver a high level of quality, consistency and efficiency with the required amount of flexibility to embrace the dynamic nature of Clinical Trial compounds and Phases.

Key Working Relation : Develops robust and productive relationships with internal and external business partners : treats others fairly and with respect; manages conflicts constructively; provides timely and relevant feedback.

Internal

• Collaborate with supporting service functions such as Standards Experts, Technical Experts, programmers and Statistical Analysts to ensure connectivity of data elements across technology platforms.
• Interact with internal IT and business partners such as Medical Writers, IT, Drug Safety etc. to troubleshoot and ensure ongoing support for study teams.

External

• Interact with external technical support staff of IT providers to troubleshoot and support maintenance of systems and study setup.
• Assist with training and education of external business partners on processes or best practices as applicable.

Minimum Requirements :

• Bachelor’s degree (or equivalent / higher), preferably in the fields of Natural Sciences, Life Sciences, Informatics, Medical Documentation or related subject.
• At least 7 years of study and / or project level experience as a Data Acquisition Specialist in supportive and leading roles, or equivalent role in a scientific, data-driven position in the medical research area.
• At least 2 years of experience should demonstrate full responsibility as a Data Acquisition Specialist, or equivalent roles in a scientific, data-driven position in 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 also be 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.
• Experienced in definition and setup of data acquisition elements in the clinical trials across different TAs 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 (e.g. 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.