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Project Management Associate

6 hours ago

Auburn Hills, Michigan, United States TFS HealthScience Full time

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a Project Management Associate - (home based in Poland, Portugal or Spain).

About this role

As part of our CDS Project Management team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Project Management Associate 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

Qualifications: 

  • 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 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

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 29 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. 

Together we make a difference.