Senior Clinical Scientist
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POST DATE 9/17/2016
END DATE 10/18/2016
Seqirus, A CSL Company
JOB DESCRIPTIONThe position holder has global scientific responsibility for a part of a clinical program. The position holder is responsible for both scientific input to clinical development strategies, acting as the primary liaison between the assigned therapeutic area and key stakeholders to ensure translation of the development plan into operational deliverables. Contribution to the scientific content of clinical program documents is a key deliverable and includes study synopses and protocols, Investigator s Brochures, clinical study reports, conference abstracts, internal and external scientific meeting presentations and peer-reviewed publications. The Senior Clinical Scientist operates with supervision and review of the Principal Clinical Scientist, Clinical Program Director and/or Therapeutic Area Head, but is the authorized representative of the Therapeutic Area on cross-functional operational teams for the conduct of clinical research.
Main Responsibilities and Accountabilities:
The position holder contributes to the scientific development of individual clinical studies in alignment with the approved clinical development plan. This includes authorship/ review of some clinical documents (protocols, CRFs, ICFs, CSRs, etc.) to ensure that the scientific content/ rigor is consistent and of the highest quality across the clinical development program.
Contributes to the clinical oversight and medical guidance in collaboration with the Principal Clinical Scientist and (Senior) Global Clinical Program Director during the conduct of the study.
Reviews clinical data with some assistance and contributes to the development of clinical presentations and integration of analyses into clinical documents. Independently review study subject level data, and present relevant issues to the medical monitor for clinical decision making, throughout the study life cycle. Liaises closely with the Benefit-Risk Physician to support ongoing aggregate safety data review during a given clinical study
Liaisons with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) and investigators. Work closely with the Clinical Operations, and Pharmacovigilance functions to ensure the translation of the protocol and clinical development plans into executable operational processes. Lead internal or external training as required and support the medical monitor in responses to investigators and other site personnel regarding clinical and study conduct questions.
Assists with the planning and monitoring of the timelines, resources and budget for the scientific part of the clinical program (Medical Writing, AdBoards etc).
May manage alone or in collaboration with clinical safety the operational functioning of data monitoring committees and/or clinical adjudication committees. May participate in and present at these meetings, as required. Manages the processes required to support external study review committees; e.g steering committees.
Participates in analyzing and interpreting final data from clinical studies, and writing/editing or reviewing results in study reports, regulatory submissions, abstracts, posters, presentations, peer reviewed manuscripts, and other documents. As required, lead internal data review meetings to determine strategic interpretation. May participate in the company publication group. Additionally serve as a scientific reviewer for company publications and external research proposals in the area(s) of expertise.
Participate in the Clinical Operations and Clinical Development teams. Provide support to the clinical development team (CDT) through meeting management support and communication. Act as the delegate for the CDT lead where required.
Manages the contractual and budget requirements for clinical strategy needs across programs including but not limited to consultants, data monitoring committees or adjudication boards.
Interact with internal auditing groups on a study level to ensure clinical development activities are conducted according to internal SOPs and work practices and in compliance with ICH-GCP.
In collaboration with Shared Services, contribute to multidisciplinary work teams evaluating and implementing continuous improvement (i.e. quality circles, SOP harmonization, ACE).