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Job Details

Senior Clinical Scientist

Company: SciPro
Location: South San Francisco
Reference: AcertaSCS
Closing Date: 13 Jun 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

The Senior Clinical Scientist supports the Medical Monitor with oversight for the direction, planning, execution, and interpretation of clinical trials and related data collection activities. The Senior Clinical Scientist requires limited oversight and review by the Medical Monitor.

Requirements:

Essential Duties/ Responsibilities

* May serve as a medical monitor for clinical trials of low complexity or provide support for medical monitoring activities on trials of increased complexity; including the oversight of all aspects of trial conduct, working closely with Medical Safety, Pharmacovigilance, Data Management, Quality, Regulatory and the study management team
* Protocol implementation including site identification and communication, attendance at investigators’ meetings, correspondence with sites including IRBs, and interaction with operation’s teams
* Cross-functional interaction with all of the disciplines necessary for successful study implementation: pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, marketing, legal, biostatistics and data management, pharmacovigilance, and clinical operations
* Data compilation for efficacy and safety evaluation
* Work closely with the project and study teams to deliver enhanced efficiencies and quality around tactical deliverables, IND and other regulatory submissions, protocol development, amendments and all supporting documents, PK/PD and clinical data collection and analysis, investigator and site communications, study reports and publications.
* Key clinical representative in cross-functional sub-team meetings.
* In collaboration with the study team, author, develop, and amend clinical study protocols, consent forms, case report forms and ancillary study documents.
* Work with Clinical Operations and Data Management in database review, query and clean-up activities in real-time and prior to database lock.
* Preparation of abstracts, posters, oral presentations, manuscripts and clinical study reports.
* Contribute to the preparation for development advisory boards as needed.
* Represent the company at congresses and investigator meetings as needed.
* Demonstrated understanding of clinical study conduct, including all relevant regulations (GCPs etc)
* Demonstrated ability for critical thinking and attention to detail
* Demonstrated effective oral and written communication skills
* Demonstrated ability to work well in a team environment, and lead moderately complex projects
* Demonstrated independence, initiative and ability to work well in a fast-paced dynamic environment
* Ability to travel (approximately 10%) to investigative sites, regulatory agencies, and to attend major oncology meetings

Requirements



* Demonstrated understanding of clinical study conduct, including all relevant regulations (GCPs etc)
* Demonstrated ability for critical thinking and attention to detail
* Demonstrated effective oral and written communication skills
* Demonstrated ability to work well in a team environment, and lead moderately complex projects
* Demonstrated independence, initiative and ability to work well in a fast-paced dynamic environment
* Ability to travel (approximately 10%) to investigative sites, regulatory agencies, and to attend major oncology meetings
* Medical or healthcare degree (MD or foreign equivalent, PharmD, PA-C, Nurse Practioner, and three years of relevant industry or academic experience in clinical research and conduct of clinical studies
* Experience in oncology and/or hematology preferred

Apply for this job: Senior Clinical Scientist

Contact Information:

Address:  Head Office
4th Floor, 150 Leadenhall Street, London
EC3V 4TE
England
Tel:  +44(0)203 327 3072
Website:  Visit Our Web Site

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