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Job Details

Clinical Data Reviewer - Sandwich

Company: CK Clinical
Location: Sandwich
Reference: KA41787
Closing Date: 10 May 18
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

CK Group are recruiting for a Clinical Scientist to join a company in the Pharmaceutical company industry at their site based in Sandwich, Kent on...

Requirements:

CK Group are recruiting for a Clinical Scientist to join a company in the Pharmaceutical company industry at their site based in Sandwich, Kent on a 12 month contract.

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 Informed Consent Document (ICD) development, safety and quality data review, patient narratives and Clinical Study Report (CSR) development.

Key responsibilities:
•Provides scientific expertise to produce clinical study protocol
oDrives and obtains protocol content and quality review
oIndependently 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
oEnsures 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 Patient Reported Outcomes (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, Targeted Medical Events

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
•BA/BS or equivalent qualification.
•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
•Applies knowledge of internal/external business challenges to facilitate process improvements
•Ability to work independently with minimal supervision
•Working knowledge of statistics, data analysis, and data interpretation
•Able to place innovative approaches into action that focus on trial execution and site performance
•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

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA41787 in all correspondence.

Apply for this job: Clinical Data Reviewer - Sandwich

Contact Information:

Address:  Head Office
9 High Street
Stevenage
Hertfordshire
SG1 3BG
England
Tel:  +44 (0)1438 743047
Fax:  +44 (0) 1438723800
Website:  Visit Our Web Site

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