Project Management Assistant (PMA), home or office based
TFS, Norway

The Project Management Associate (PMA) is aligned to and managed under the assigned therapeutic business unit. The PMA will function operationally as a member of the study team and provide administrative support to the Project Manager (PM). The PMA will complete tasks associated with the planning, preparation, and study execution to ensure that the project completion within the agreed timelines, budget, and according to company policies, SOPs, and regulatory requirements.

Key Responsibilities:

• Set up and ensure access is provided to the study team to all systems and tools required for the management of the study
• Set up, maintenance and accurate periodic update of study information in the Clinical Trial Management System (CTMS) as per delegation from PM/CRM (Clinical Research Manager)
• Set up and maintenance of study contact lists
• Set up and maintenance of Issue Action and Decision Log and FAQ log
• Support PM and CRM with vendor management
• Assist study PM, CRM and CRAs (Clinical Research Associates) with the administration task of the studies as delegated by PM/CRM
• Drafts and/or assists with the preparation and tracking of trial-related documents, tools and templates as directed by PM/CRM
• Assist PM/CRM in status reporting
• Support planning and logistics for meetings to include internal and external meetings and provide assistance in the organization of Investigator Meetings
• Actively take part in study meetings and be responsible for the meeting minutes during the call
• Generate, finalize and distribute meeting agenda and meeting minutes
• Prepare, contribute to and distribute presentation material for meetings and newsletters
• Act as central contact for the study team for designated project communication as directed by PM
• Mass site communication- maintaining site and client distribution lists and sending communication as delegated by PM/CRM
• Assist and attend activities associated with audits and regulatory inspections
• Management of Investigator Payments as directed by PM or CRM, ensuring that payment requests are aligned to contract and milestones

• Management of invoice tracker and support with financial reconciliation
• Assist in the collection of appendices for final Clinical Study report
• Assist the PM with document translations process
• Actively contribute to the organization and development of routines to enhance the work at TFS
• Develops and maintains an effective relationship with the study teams and Sponsor
• Supervisory support to other PMAs as deemed necessary
• Set up the Investigator Site File as directed by the CRM and forward the CRM a tracker of all document sections within the ISF. This activity may be delegated to PMA and/or TMFa (Trial Master File Associate) depending upon study needs
• Maintain the study master file (usually via SharePoint or as otherwise specified) as directed by the /Project Manager/TFS SOPs. This activity may be delegated to PMA and/or TMFa (Trial Master File Associate) depending upon study needs
• Coordinate and distribute study supplies as deemed necessary
• Work with the study team in all regulatory processes including submission and amendments, regulatory fees

Requirements

• Bachelor’s Degree and/or equivalent work experience preferred
• Knowledge of GCP/ICH guidelines
• Good written and communication skills
• Good organizational and multi-tasking skills
• Good software and computer skills
• Excellent knowledge of English language, knolwedge of Norwegian language is a plus
• Able to work in a fast paced environment with changing priorities
• Intuitive, proactive team player
• Effective time management
• Strong Customer service orientation
• Problem solving skills

Benefits

• Health Care Insurance
• Corporate Pension Plan

• Life Insurance
• Global General Liability Insurance
• Global Travel Insurance
• Entrusted working time

Job Rewards and Benefits