Principal Research Scientist

Job description

Details:
Job Description Summary-Job Family - Clinical Development: Responsible for oversight of development and execution of studies linked to worldwide clinical development plans for assigned programs in portfolio. Responsible for integrating clinical development objectives with global considerations into strategic business decisions. Ensures clinical, operational and medical governance excellence across all clinical development projects for assigned programs.

Job Family Group - Medical and Clinical: Evaluates the efficacy and safety of drugs in human clinical studies. (Phases I to IV) involving patient interaction and/or research, consulting, bench work and/or analysis. Provides medical expertise to ensure the proper development of new products and the optimal positioning and promotion of existing products.

Job Description-The role will:

• Be responsible for the delivery and quality of all clinical studies from protocol concept to execution to final study report and for the validity of all data originating from studies.
• Be responsible for reviewing and/or enhancing the technical and scientific robustness of clinical plans and studies developed by the key customers for their designated area, while inputting and influencing.
• Lead operational excellence and data quality focus negotiations with vendors and strategic partners.
• Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
• Make decisions which balance risk/benefit with clear understanding of impact on project; takes action to mitigate risk where appropriate.
• Be accountable for a number of studies at any point in time.
• Develop and maintain the global study budget.
• Ensure set up and maintenance of all systems in order to plan and implement the study and track progress.
• Ensure appropriate clinical trial supply strategy is implemented and managed.
• Ensure efficient streamlined processes are in place to deliver study to plan and ensure safety of patients and completeness/integrity of data.
• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
• Be accountable for timely delivery of scientifically and operationally robust study documents.
• Lead a cross functional study team to author a focused study protocol that meets scientific objectives and can be implemented in the clinic to provide quality data and ensure timely study delivery.
• Lead development, review, finalisation and delivery of high quality key clinical study documents (including final Clinical Study Reports) in order to meet study timelines.
• Ensure accurate maintenance and archiving of study records.
• Be accountable for clinical vendor selection and contractual agreements.
• Drive assessment, selection, engagement, training and management of appropriate vendors for outsourced clinical activities/services, ensuring compliance with GSK standards.
• Be accountable for site and monitor training in operational aspects of the study.
• Ensure monitoring and site personnel are familiar with all study-specific processes, procedures and systems and that training is adequately documented.
• Be accountable for study related communications and for resolution or escalation of operational issues.
• Develop study communication plan to ensure efficient and appropriate global communication to all internal and external stakeholders.
• Ensure processes are in place to address or escalate study issues as they arise.

Contact information:
You may apply for this position online by selecting the Apply now button.

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Desired profile

Basic qualifications:
• Broad understanding of the pharmaceutical industry and the clinical development process
• In depth knowledge of study management and data management and knowledge of essential regulatory guidelines worldwide and GSK company policies.
• Experience authoring high quality clinical protocols and reports (or equivalent types of documents).
• Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
• Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
• Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
• Demonstrated effective oversight of outsourced activities.
• Excellent leadership skills
• Excellent influencing and negotiation skills

Preferred qualifications:
Preferred Requirements
• Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience
• Demonstrated experience leading in both matrix and line environment to deliver projects, develop clinical plans, and manage change