Clinical Study Lead

This position is open for candidates with a MD, a PhD or a Pharmacist degree with min 3 year's of experience in clinical project coordination/management.

Job Description

As Clinical Science Lead, you participate to Phase I-IV Clinical Development activities within a program or group of related programs, in order to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, GCP, and SOP.

Responsibilities

Participate in Clinical Development activities for a study or a number of studies within a specific program or group of related programs.Contribute to activities or components of a Clinical and Epidemiology Plan (CEP) as appropriate

• Define the outline and content of the protocol,
• Analyse and interpret the results as a subject matter expert.
• Supervise the study conduct, and serve as the accountable for the overall delivery of the clinical trial.
• Assure that results meet the highest standards of quality and ethical conduct.
• Support to Independent Data Monitoring Committee (IDMC).
• Completes tasks in support of these activities as necessary, such as developing internal and external briefing documents, and other such activities requiring relevant technical expertise and clinical development experience.
• Support the regional clinical strategy for a project through Clinical development, in partnership with relevant matrix team members.

Serve as a scientific and management representative for the project

• Assumes accountability for the medical/legal and human safety aspects of the clinical study. (If not an MD, assembles and transmits timely summaries of clinical safety data for review by competent medical officer).
• Responsibility for Data Listing review for the medical portion of data listing for individual studies, assure medical consistency within trial and across trials within program.
• Address scientific and medical issues related to one or more clinical studies. Pay special attention to serious adverse events occurring during clinical trials and potential safety signals.
• Liaise with PV to develop Risk Management Plans (RMPs), Global Safety Data sheets, Development Safety Updated reports (DSUR), and Periodic Safety Updated Reports (PSUR) and serves on SRT (Safety Review Team), as applicable. In clinical studies, together with PV analyse safety and potential signals and escalate accordingly.
• Publishes clinical data in peer review journals and presents in external scientific meetings/congresses.
• Maintains and expands knowledge in medical and scientific competencies (as appropriate), vaccinology and trial methodology.
• Supports internal process improvement activities and initiatives.
• Liaise with the Regional Evidence Generation team to ensure alignment of clinical trial activities (includes but not limited to, scientific and medical issues as well as subjects safety).

As a member of the Clinical Project Team, always actively participate and engage within the project matrix.

• Actively participate as a core member of the clinical project team and contribute to achievement of team objectives.

Actively participate in preparing the clinical portion of the regulatory files and the registration process

• Contribute to development of clinical section of regulatory files, including labeling.

Requirements

• MD, PhD or Pharmacist degree
• Min 3 year's experience as clinical project coordinator/manager
• Previous experience in clinical vaccinology is an asset.
• Basic knowledge and understanding of vaccines, clinical research, and biomedical research regulation, including ICH and GCP.
• Working knowledge and understanding of causes of infectious diseases, health interventions and the global public health landscape.
• Sensitivity to the needs of a diversified ethnic groups and ability to build rapport across the spectrum.
• Strategic thinking skills and achievement oriented.
• Able to critically analyse information, identify strengths and weaknesses of approaches and develop remedial actions to mitigate risks.
• Needs to possess highly effective communication skills and be capable of presenting ideas and data clearly to various audiences.
• Excellent knowledge of spoken and written English.

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