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Study Start-Up Specialist

Job Description

19-05195 / Study Start-Up Specialist /  Biotech Industry 
South San Francisco, CA

3 year contract - Huge opportunity to make a great impression at one of the leading Biotech companies in the world! 

*Multiple level of positions open! Depending on local needs the responsibilities of this role can be covered by Clinical Study Manager (CSM) or Country Study Specialist CSS roles (decision maker local Country Head or Medical Director).

Main Qualifications:
  • University Degree preferably in a medical/science-related field.
  • Prior work experience demonstrating knowledge and understanding of clinical trials.
  • Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country.
Summary of job:
The Study Start-up (SSU) Specialist functions as a subject matter expert on all SSU-related activities in the country/region, oversees and leads SSU activities in collaboration with other clinical research stakeholders and serves as a leader for local/global SSU process improvements and patient recruitment strategies.

-Condensed job description-
RESPONSIBILITIES
Study Start-up Coordination and Execution:
  • Coordinates, guides and assists with all start up activities prior to site activation, including but not limited to:
    • Site Informed Consent Form (ICF) localization and guidance in line with regulatory / health authority requirements
    • Ethics Committee information, meeting dates & costs
    • Ethics applications & associated online systems
    • Ethics & Governance submission processes
    • Clinical Trial Health Authority application and regulatory submission process
    • Contracts & Indemnity request process
    • Localize global Informed Consent Form (ICF) with country requirements
    • Other materials and documentation used by the study requiring local governance approval
  • Maintains up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation
  • Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation
  • Ensures all start up information & requirements are kept up to date in a central repository for project teams
  • Assists with label preparation and approval (local label representative) for studies in collaboration with local regulatory department
  • Tracks metrics and study start-up timelines to identify trends and opportunities for improvement
 Other skills:
  • Demonstrated competence in analysis, planning and problem solving.
  • Excellent communications skills including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution.
  • Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English.
  • Experience working as part of a team with a proven ability to make an active contribution to the team's performance and teamwork.
  • Able to make effective decisions, self-motivated, assertive, and displays initiative.
  • Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility.
  • Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.
*Those authorized to work in the U.S. are encouraged to apply / Unable to Process H1B visa at this time / Unable to work on a C2C basis for this role* 

Job Requirements

 

Job Snapshot

Location US-CA-South San Francisco
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Clinical & Scientific, Other
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Company Overview

Ascent

The Ascent Services Group (ASG) is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. ASG’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Learn More

Contact Information

US-CA-South San Francisco
Bonnie Galley
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Snapshot
Ascent
Company:
US-CA-South San Francisco
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Clinical & Scientific, Other
Store Type:

Job Description

19-05195 / Study Start-Up Specialist /  Biotech Industry 
South San Francisco, CA

3 year contract - Huge opportunity to make a great impression at one of the leading Biotech companies in the world! 

*Multiple level of positions open! Depending on local needs the responsibilities of this role can be covered by Clinical Study Manager (CSM) or Country Study Specialist CSS roles (decision maker local Country Head or Medical Director).

Main Qualifications:
  • University Degree preferably in a medical/science-related field.
  • Prior work experience demonstrating knowledge and understanding of clinical trials.
  • Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country.
Summary of job:
The Study Start-up (SSU) Specialist functions as a subject matter expert on all SSU-related activities in the country/region, oversees and leads SSU activities in collaboration with other clinical research stakeholders and serves as a leader for local/global SSU process improvements and patient recruitment strategies.

-Condensed job description-
RESPONSIBILITIES
Study Start-up Coordination and Execution:
  • Coordinates, guides and assists with all start up activities prior to site activation, including but not limited to:
    • Site Informed Consent Form (ICF) localization and guidance in line with regulatory / health authority requirements
    • Ethics Committee information, meeting dates & costs
    • Ethics applications & associated online systems
    • Ethics & Governance submission processes
    • Clinical Trial Health Authority application and regulatory submission process
    • Contracts & Indemnity request process
    • Localize global Informed Consent Form (ICF) with country requirements
    • Other materials and documentation used by the study requiring local governance approval
  • Maintains up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation
  • Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation
  • Ensures all start up information & requirements are kept up to date in a central repository for project teams
  • Assists with label preparation and approval (local label representative) for studies in collaboration with local regulatory department
  • Tracks metrics and study start-up timelines to identify trends and opportunities for improvement
 Other skills:
  • Demonstrated competence in analysis, planning and problem solving.
  • Excellent communications skills including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution.
  • Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English.
  • Experience working as part of a team with a proven ability to make an active contribution to the team's performance and teamwork.
  • Able to make effective decisions, self-motivated, assertive, and displays initiative.
  • Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility.
  • Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.
*Those authorized to work in the U.S. are encouraged to apply / Unable to Process H1B visa at this time / Unable to work on a C2C basis for this role* 

Job Requirements

 
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Study Start-Up Specialist Apply now