Global Clinical Trial Associate

Global Clinical Trial Associate

Pharm-Olam

Multiple countries

Summary

Acts as the focus for the project team administration and provides the Project Manager and all other project team members with advice, assistance and support, as required, thus ensuring that the clinical trial is conducted in accordance with international regulatory and ethical guidelines for Good Clinical Practice and Standard Operating Procedures. Assists the study team with the day-to-day conduct of international clinical studies.

Note: Some responsibilities related to TMF maintenance will vary according to the study specific TMF processes. Responsibilities related to collection of critical documents may be delegated to a country-specific start-up or regulatory group, as applicable.

Responsibilities

  • Provides continuous support to Clinical Team Leaders (CTL) and Project Managers (PM) with the day-to-day administrations of clinical studies;
  • Prepares and maintains Trial Master File (Trial Level File) according to Pharm-Olam SOPs or Sponsor SOP, as required;
  • Prepares and maintains QC/Inventory Checklist for the TMF – Trial Level File;
  • Reviews study file periodically for accuracy and completeness – Trial Level File;
  • Prepares and maintains study trackers for the global study team as per Project Manager’s instructions, as needed;
  • Performs QC of the TMF – Trial Level File;
  • Maintains Public Folders/ePOI/S drive in accordance with the Filing Plan – Trial Level;
  • Coordinates and tracks completion of the TMF QC in study countries (CMF, and IF) and assists PM/CTL in related QC activities, as required;
  • Prepares draft version of the Filing Plan, communicates with the PM team for reviews and comments, prepares the final version and distributes to the team;
  • Adapts ePOI/S drive filing folders to reflect study specific Filing Index;
  • Communicates with the Sponsor on all filing relates issues;
  • Assists PM/CTLs in preparation of Project Specific Training Matrix (PSTM) and prepares and maintains Global Team Training Tracker. Follows up with the study team on pending training items;
  • Provides guidance and support to local study teams (CRAs/CTAs) with filing related issues;
  • Trains the study team on project-specific filing requirements and TMF QC plans and methods;
  • Communicates with Vendors, if needed. Organizes centralized printing of study documentation (dividers, mini protocols, etc) and distribution to study countries;
  • Assists PM/CTL with tracking of essential documents and documentation required for submissions in the countries involved in the study;
  • Performs CTMS Trial Level related activities delegated by the PM/CTL and follows up all issues until resolution;
  • Acts as a central contact for the clinical team for designated project communications, correspondence, and associated documentation;
  • Follows up study team or Sponsor requests for clarifications;
  • Assists PM/CTL with creation of study specific forms/logs based on SOP appendices for TMF and Investigator Site Files;
  • Attends Kick-off Meetings, Investigator and CRA meetings or other F2F meetings, as required. Records questions and answers. Presents filing organization for particular study;
  • Assists PM/Vendor (meeting organizer) in preparation of the Investigator Meeting;
  • Attends clinical teleconferences, and prepares and distributes minutes for Sponsor and Project Teams within agreed timelines;
  • Attends handover meetings for local CTAs involved in the project for supervision purposes;
  • At the end of the study coordinates local teams with sending study files to Sponsor;
  • Performs any other administrative tasks not listed above to support team members with clinical trial execution, as required;
  • Generates and reviews management reports from internal tracking systems at requested intervals and follows-up on pending entries;
  • Assists in activities related to study payments in CTMS, as needed;
  • May participate in feasibility and/or site identification activities;
  • Assisting PM/Sponsor with drafting and formatting of the study newsletter, as required;
  • Reviews project-specific WTS for CTA study team (local CTAs and other PCTAs if any) if required by the PM.

Non-study related tasks:

  • Provides training and mentoring to junior CTAs on Pharm-Olam procedures and clinical trial administration, if required;
  • Resolves logistical and practical issues, and promotes the team-working environment;
  • If needed, attends non-study related teleconferences and meetings, and prepares and distributes minutes for meeting attendees within agreed timelines;
  • Contributes to improvement of filing quality and cooperates with Department Head on related activities, as required.

Working Relationship:

  • Reports to Global Clinical Trial Associate Manager;
  • Collaborates with project teams and all Pharm-Olam staff;
  • Communicates with Sponsor and sub-contractors if requested by Project Manager;
  • Collaborates with Training Department.

Qualifications

  • Experience of at least 1 year as Sr CTA I or within a similar role;
  • Experience in managing eTMF;
  • Fluency in English (spoken and written);
  • Sound knowledge of medical terminology and clinical monitoring process;
  • Strong verbal and written communication skills;
  • Computer literacy, proficiency in Microsoft Office;
  • Excellent interpersonal and organizational skills;
  • Ability to work independently and to effectively prioritize tasks;
  • Ability to manage multiple tasks within a project or multiple projects;
  • Attention to detail;
  • Ability to establish and maintain effective working relationships with co-workers, managers, investigational site personnel and vendors;
  • Excellent management skills in order to successfully train and organize the team, to supervise, prioritize and delegate;
  • Ability to meet deadlines;
  • Effective problem solving skills;
  • Excellent presentation skills;
  • Ability to work remotely with diverse teams.

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© EuroJobsites 2018

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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