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Clinical Scientist


Remote, OR 97458
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Job Details

**Clinical Scientist - Senior Manager**

**Role Summary:**

The Clinical Scientist is responsible for bringing together clinical, scientific and technical disciplines to ensure high quality protocol development, study execution and data interpretation. They will be responsible for clinical sciences deliverables on one or more interventional clinical trials, with the opportunity to work across multiple Therapeutic Areas within Global Product Development (GPD).

The Clinical Scientist is a key member of the study team and partners closely with the TA clinician and clinical operations team members, applying technical and scientific excellence to support the development and execution of clinical trials to meet the needs of internal and external customers.

Specific clinical scientist responsibilities impact key elements of the study lifecycle including protocol and ICD development, safety and quality data review, patient narratives and Clinical Study Report (CSR) development.

**Role Responsibilities:**

+ Provides scientific expertise to produce clinical study protocol

+ Drives and obtains protocol content and quality review

+ Independently writes/designs protocol outlines, protocols, and amendments of moderate complexity in collaboration with the TA Clinician, Global Clinical Lead, Clinical Operations, and other relevant groups

+ Ensures study registration forms are complete and protocol amendment forms are updated

+ Ensures appropriate CRF design, creates ICDs, and is responsible for the selection and implementation of PROs

+ Partners with data management to develop data review plan for review of data.

+ Responsible for establishing and management of Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes

+ Reviews patient level and cumulative data per the data review plan across a study and coordinates with TA Clinician for study level review.

+ Reviews protocol deviations.

+ Reviews safety data, SAE reports, TME's, DME's and ensures clinical documents (eg ICD) are updated as required.

+ Tracks and reconciles serious adverse events (SAEs) across a study and reports SAEs during Safety Review Team meetings.

+ Collaborates with TA Clinician to provide medical/scientific guidance during the execution of the study.

+ Develops specific medical/protocol training for Site Initiation Visits and Investigator Meetings, and for Pfizer site facing roles and vendor / CRO staff.

+ Identifies scientific quality issues to discuss with clinicians and operations study team members so that corrective actions may be instituted.

+ Escalates protocol-related issues requiring complex medical expertise to the TA Clinician.

+ Escalates operational issues to the appropriate operations study team member.

+ At the asset level, assists the Global Clinical Lead and TA Clinician in the preparations of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR, medical narratives).

May support and contribute to various sections of regulatory documents (Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, and Periodic Safety Update Reports and Regulatory authority responses).

**Qualifications and experience:**


+ Required: BA/BS or equivalent qualification.

+ Preferred: M.D., Ph.D., D.V.M., M.S., and/or PharmD. or equivalent qualifications. Postgraduate training/certification/ fellowship in a clinical / scientific discipline or in drug development. Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.).


+ Knowledge and experience in Good Clinical Practices

+ Experience in execution of clinical trials, including data review and investigative site relations

+ Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval)

+ Practical experience in clinical trial strategies, methods and processes

+ Track record of design, oversight and interpretation of clinical studies

+ Proven scientific writing skills, with strong inter-personal, written/verbal communication skills, including ability to evaluate, interpret and present complex data


+ Proven ability to get results in a matrixed management environment

+ Extensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field

+ Demonstrated ability and level of experience with integrating and summarizing medical/scientific concepts in protocols and other clinical documents

+ Independently author clinical protocols and other clinical study documents

+ Working knowledge of statistics, data analysis, and data interpretation

**Closing Statement**

Locations available: UK remote working, France, Italy, US remote working

This position holds a UK Grade 13.

Closing date: 15th April 2018.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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