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Study Start-Up Specialist
Ref No.: 19-02984
Location: South San Francisco, California
 Join a Team that Lives to Improve Lives!

"People come from across disciplines and across the world to solve our most challenging medical conditions. You'll find inspiration in our passion for biotechnology, our purpose to positively impact the lives of millions of patients and our dedication to our people. Joining our team means being part of a tradition of inquiry that will change the world.​"

Team Dynamic:
  • Team was comprised of 4 Study Start-Up Specialists (SSUSs) and one line manager.
  • To meet the need of the increasing number of insourced studies, as well as the expansion of the portfolio, the SSU team has grown significantly to the current size. 
  • The SSU team is comprised of many diverse individuals, many of whom originally joined us from other companies, and several have experience living and working in different countries.
  • Though the team has grown significantly, team members remain very closely knit and collaborate frequently.   
Position Purpose:
The Study Start-up Specialist (SSUS) is responsible for all SSU-related activities in the country/region, on assigned studies, overseeing and leading SSU activities in collaboration with other clinical research stakeholders.

Main Responsibilities and Accountabilities:
  • Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.
  • Executes all start-up activities prior to site activation on assigned studies, according to  standards and aligned with study/project requirements and timelines.
  • Prepares country level Informed Consent Form (ICF) and obtains ethics committees' and local regulatory authorities' approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country.
  • Maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.
  • Partners with Clinical Study Managers (CSMs) and Clinical Study Specialists (CSSs) to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations.
  • Supports drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory/Quality department, as required.
  • Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies/ laws, via innovative approaches
  • Submits, according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SUSARs), Six Monthly SUSAR Reports (SSRs) and Development Safety Update Reports (DSURs).
  • In collaboration with CSMs, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required.
  • Responsible for study budget and contracts negotiation in collaboration with Contracts Manager/Associate, as required and ensures compliance with Fair Market Value (FMV) in the country.
  • University Degree or equivalent, preferably in a medical/science-related field.
  • Demonstrated knowledge and understanding of clinical trials and experience in managing projects.
  • Demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices (ICH-GCP), as well as understanding of the regulatory, ethics and contractual requirements for starting clinical trials in the relevant country.
  • Previous line management experience/supervision of staff is preferred.

Other Job Duties:
  • Assisting with Site Activation Planning and Recruitment Planning 
  • Help with Site Selection: North America process ( SSNAP)
  • ICF Negotiation
  • Manage  Fair Market Value (FMV)
  • GLF/Site Activation/Handover
  • Overall manage site feasibility, study start up and some recruitment 
  • Work with a variety of tools, networks and alliances 

We look forward to new members joining our team!