Senior Clinical Trials Specialist

South San Francisco, California
Aug 03, 2018
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

• Assist in the execution of clinical trials with minimal guidance/supervision in alignment with Good clinical practice (GCP) and Theravance Standard Operating Procedures
• Accountability for key study related activities under the supervision of a Lead Study Manager
• Continue development of skills, knowledge in the management of clinical study trials as per GCP/ICH Guidelines

Context & Responsibilities:
• Support Lead Study Manager in execution of clinical study design and implementation according to Good clinical practice (GCP) and Theravance Standard Operating Procedures
• Responsible for overall global tracking of study deliverables with escalation of key issues/trends
• Support and/or manage protocol related site/supplier activities and follow up as delegated by Supervisor
• Support and/or manage global study initiation and set-up activities, including vendor management and coordination of study and study implementation plans

Key Activities:
• Assist and/or manage in the design, format, review and content of study guides, worksheets, quick reference cards and other materials/documents used to support the study
• Attend and contribute to vendor/CRO/team meetings and work with vendors to help resolve issues and foster process improvements
• Monitor progress of studies, help identify study related trends/issues and work with CSM to implement corrective actions when necessary
• Submission of documents to TMF, as applicable
• Assist with maintaining Freq. Asked Questions (FAQ) log
• May assist with the quality control of clinical data for clinical study report preparation
• Assist CRMs with meeting Agenda and maintain Minutes for internal team meetings
• Point of contact (as delegated by CSM) for study related issues
• May Participate in Line Listing Reviews and QC of data
• May contribute to development of recruitment strategies and materials
• Work with PKDM/ Micro/Labs to help coordinate shipment and analysis of samples as needed
• Manage Temperature Excursion process flow
• Help coordinate Investigator Meeting, CRA workshops, and other vendor meetings as applicable
• Track Assist in the study level investigational product accountability and reconciliation for in-house studies and at close with depots
• May provide clinical site support via providing materials to site/clinical field CRA’s
• May participate in cross -functional process improvement groups
• Support and contribute to Inspection Readiness process 
• Develop increased knowledge of clinical research and clinical operations management activities
• Posting to clinical trial websites
• Assign and track Monitoring Report Review to team members

Key Output:
• Contribute to protocol review, content and QC of protocol and ICF
• Study related documents, plans and status reports, as delegated
• Investigator, Coordinator and CRA training meetings, as delegated
• Site Selection and Approval, as delegated
• Monitoring Report Approval, as delegated
• Study status reports
• TMF filing and QC TMF
• Study Tracking and Metrics 
• Newsletters
• UAT participation 
• Contribute to Study Guides and Initiation documents (slides, manuals, quick reference cards etc.)
• Assist with Monitors/Site Protocol Training and IM /workshop planning
• Contribute to the development of study tools/templates/recruitment aids
• Assist CRM in review, routing (legal) and finalization of ICFs (global template and site specific ICFs

Decision Authority:
• As delegated by the Supervisor, decisions related to the execution of the clinical trial

Basic Qualifications:
Combination of degree and relevant Biopharma related experience within a pharmaceutical, biotech environment or relevant CRO:
• Bachelor’s degree and 3 years of directly related experience
• Associates degree and 5 years of directly related experience
• High school diploma/GED and 6 years of directly related experience

3 years direct experience in a Clinical Operations related function/role

• Associates Degree or BS/BA/BSc in the sciences or RN
• 5 years work experience in life sciences or medically related field, including 3 years of supporting biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a pharmaceutical, biotech or CRO company)

• Phase experience based on role
• Experience on Clinical Operations related activities within a matrixed team
• Participation/engagement in managing suppliers at Study Level/Project Level
• Understand Inspection Readiness/Regulatory considerations for their role
• Demonstrated ability to work independently

Core Competencies:
• Good Clinical Practice (GCP), ICH, and/or familiarity with standard clinical operating procedures
• Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint required
• Strong written and verbal communication
• Self-Motivated
• Knows when to escalate to management
• Ability to deal with time demands, incomplete information and prioritize tasks
• Ability to maintain a calm, professional demeanor despite demanding deliverables
• Flexible, team-oriented
• Results-oriented
• Excellent multitasking skills