Clinical Trial Specialist

4 weeks ago

Perth, Western Australia Pharmiweb Full time
Job Summary

As a Clinical Trial Specialist at Pharmiweb, you will be responsible for providing quality deliverables at the country level and following project requirements and applicable country rules, with oversight from the SSU Country Manager.

Key Responsibilities

  • Work within the forecasted submission/approval timelines and ensure they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached provides clear rationale for delays, assists with contingency plan to mitigate impact, and escalates the issue as soon as identified.
  • Monitor basic financial aspects of the project and the number of hours/tasks available per contract; escalate discrepancies in a timely fashion.
  • Review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keep training records updated accordingly and ensure timesheet compliance.
  • Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Additional Responsibilities

  • Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SAL. May serve as a point of contact for the SAL/PM (or designee) during start-up on allocated projects. Compiles and/or reviews essential document packages for site activation and may also be involved in essential document collection from site.
  • Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required and under supervision. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with oversight from the SSU Country Manager.
  • May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversee site activation end to end process at country/site level.
  • Local Site ID and Feasibility Support - Provides support with site selection lead and PM/SAL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
  • Local Investigator Contract and Budget Negotiator - Supports the SAL to agree on country template contract and budget. Assists in producing site-specific contracts from country template. Under supervision assist in negotiations of budget and contract with site and via Site Contracts Service Centre and SAL lead with Sponsor until resolution of issues and contract execution. Assists with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.

Requirements

  • Associate degree or equivalent combination of education and training.
  • Good understanding of clinical trial process across Phases II-IV and ICH GCP, Ability to interact effectively and appropriately with investigative site personnel.
  • Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively.
  • Ability to take direction from multiple individuals and set priorities accordingly.
  • Ability to effectively communicate across multiple function groups (clinical team, PM, Director).
  • Demonstrated ability to work independently, as well as part of a team. Utilize problem-solving techniques effectively.
  • Quality-driven in all managed activities.
  • Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions.
  • Strong computer skills, including Word, Excel, PowerPoint, Publisher.

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