Take on Lead CTA responsibilities on regional studies providing additional top-level project support and coordinating the regional CTA team.
Act as a mentor to junior CTAs and to any temporary staff who are employed on an ad hoc basis. Assist with training for the team and be prepared to offer written feedback on performance of junior CTAs as part of the Sponsor appraisal process.
Set up, co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including preparation for internal/external audits, final reconciliation and archival, according to the requirements of ICH GCP and Sponsor (or Novotech) SOPs. Lead and coordinate the TMF QC and review process.
Coordinate the initiation and set up and maintenance of the Clinical Trial Management System (CTMS). Leading the review of CTMS compliance report to ensure study data is kept up to date.
With direction from PM/CRA, manage and support the essential document management process according to Good Documentation Practice, ICH GCP and Sponsor (or Novotech) SOPs. Compile Project, Country and Site Activation Forms(s). Be responsible for drafting Essential Documents e.g. Financial Disclosures, Contracts, Indemnity, FDA 1572 etc. as per Sponsor SOPs and coordinate circulation for review as required by project team.
Perform day-to-day vendor management, liaison, and tracking, as delegated by the PM.
Perform planning and tracking of Investigator site finances, invoicing and finance reconciliation, as delegated by PM. Drafting and implementation of project SVT.
Track study progress, as delegated by the Project Manager (PM) and provide updates / reports on study progress to LCRA/PM as required.
Co-ordinate printing & distribution of ethics submission documents as requested by study team.
Source, co-ordinate, track and manage distribution of study materials, data and documents between clinical sites, Novotech and Sponsor. Materials including Investigational Product, study equipment, lab kits, Investigator Site Files etc. according to the logistical requirements of the study. Ensure safe and orderly storage of study materials at Sponsor, and maintain stock reports as requested by the PM.
Assist with drafting agenda and attending project team meetings and to generate and distribute meeting minutes, as delegated by the PM. Providing written and verbal updates if required.
Assist the PM with drafting of relevant study plans where appropriate.
Qualifications
At least 3 years experience in a Senior Clinical Support Associate Flex role or equivalent. Practical experience and/or qualifications in business administration or healthcare administration.
Prior background in the pharmaceutical, CRO or healthcare industry is advantageous.
Skills and Competencies
Strong customer focus, attention to detail, excellent communication and interpersonal skills and the ability to multi-task and function independently as required.
Good computer literacy e.g., MS Word, Excel, PowerPoint, internet.
Good in maintaining good working relationships with sponsors members.
Job details are sourced from the employer's original posting.
