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Alan O'Riordan
Life Science

[email protected]
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Clinical Research Scientist - Diabetes

Reference:AOORAPHN-204707 Location: Cork
Cork City
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Scientist

Development Clinical Research Scientist

Diabetes Technical Lead

Through the application of scientific training and clinical training and expertise, the Development clinical research scientist participates in: the development, conduct, and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization.

The clinical research scientist serves as a scientific resource for study teams, departments, and others as needed. The Clinical Research Scientist must be aware of and ensure that all their activities comply with current local and international regulations, laws, guidance (for example, FDA, ICH, CPMP, etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.

The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds.

Clinical Planning
  • Collaborate with the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans, and study protocol design.
  • Contribute to the global alignment of clinical strategy and clinical plans
  • Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
Clinical Research/Trial Execution and Support
  • Plans collaborate on and review the scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed-upon project timeline.
  • Provide protocol oversight and input into informed consent documents.
  • Supports the monitoring of patient safety during the study and participates in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
  • Review and collaborates with Development Medical Director on the approval of risk profiles to ensure appropriate communication of risk to study subjects.
  • Participate in investigator identification and selection, in conjunction with clinical teams.
  • Ensure that the operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
  • Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
  • Serve as a resource to clinical operations/ clinical research monitors, investigators, and ethical review boards to address any questions or clarify issues arising during the conduct of the study.
  • Understand and actively address the scientific information needs of all investigators and personnel.
  • Review lIT proposals and publications, as requested

Scientific Data Dissemination/Exchange
  • Knowledge of and compliance with local laws and regulations, global policies and procedures, compliance guidelines concerning data dissemination, and interactions with external healthcare professionals.
  • Understand and address the unsolicited scientific information needs of external healthcare professionals according to the guidelines above.
  • Participate in reporting of clinical trial data in Clinical Trial Registry activities.
  • Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
  • Prepare or review scientific information in response to customer questions or media requests
  • Provide telephone follow-up or specific written information requested by healthcare professionals as per global SOPs.
  • Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis.
  • Support medical information associates in the preparation and review of medical letters and other medical information materials.
  • Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).
  • Develop and maintain appropriate collaborations and relationships with relevant professional societies.
  • Support training of medical personnel, including geographic/affiliate medical personnel as assigned, medical and outcome liaisons, and global patient outcomes personnel.
  • Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.

Regulatory Support Activities
  • Participate in the development and review of label changes and labelling modifications in collaboration with affiliates, brand teams, regulatory, and legal.
  • Provide medical expertise to regulatory scientists.
  • Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports, and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.
  • Participate in advisory committees.
  • Participate in risk management planning along with affiliates and Global Patient Safety (GPS).

Scientific /Technical Expertise and continued development
  • Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product
  • Responsible for the scientific training of the clinical study team.
  • Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
  • Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near-term (1-2 years) and longer-term (3-5 years).
  • Explore and take advantage of opportunities for extramural scientific experiences

General Responsibilities
  • Actively set and meet individual professional development goals and contribute to the development of others.
  • Support the management team, in the preparation and administration of the budget.
  • Actively participate in recruitment, diversity, and retention efforts.
  • Collaborate proactively and productively with all alliance, business, and vendor partners.
  • Participate in active coaching by providing timely and constructive feedback to co-workers, and others on the medical team, in the spirit of development, increased team effectiveness, and cohesiveness.
  • Ensures that at all times is adequately qualified and trained in the tasks required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self.
  • Model leadership behaviours.
  • Be an ambassador for both patients and the Lilly Brand.

  • 4+ years in the pharmaceutical industry, preferably in a clinical position.
  • Specialisation in diabetes (4+ years).
  • Experience in areas related to drug discovery/ drug development.
  • EU Citizenship/ Stamp 4 visa ideally.
  • An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, Ph.D., MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of following
  • Minimum of 3 years of professional experience in pharmaceutical drug development with demonstrated experience and knowledge of clinical research and the drug development process.
  • Fluent in English, written and verbal communications
  • Ability to engage in occasional domestic and international travel to the degree appropriate to support the business of the team.

For further information, contact Alan on[email protected]/ 087 365 7522