TFS HealthScience is excited to be expanding our Ophthalmology team and we are looking for an experienced, highly motivated Associate Project Manager (APM) who shares our vision of providing clinical research excellence. Our Ophthalmology team is a highly experienced international group of professionals led by an industry expert.

We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.

Our cores values of Trust, Quality, Flexibility, Passion and Sustainability are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation.

Together we make a difference.

TFS HealthScience is looking for an Associate Project Manager home based in Europe.

We look forward to receiving your application soon!

The Associate Project Manager will support the (Senior) Project Manager/ Associate Project Director in Management of the projects in accordance with company policies, SOPs, regulatory requirements in addition to financial and contractual obligations.

Responsibilities

• Communicates with clients to successfully manage the relationship.
• Maintains sound business practices
• Actively contributes to the organization and development of processes to enhance the work at TFS
• Perform tasks as outlined below based on delegation by the line manager and / or project manager
• Supports PM in delivery of projects on-time, within scope and within budget and in compliance with applicable quality standards.
• Support the PM with budget set-up, budget review, invoicing, tracking of change(s) in scope and Pass-Through Costs as appropriate
• Supports the PM in development and maintenance of Project Plans and
  timelines for their project and track progress.
• Support the PM in development and maintenance of other steering documents such as Monitoring Plan
• Ensuring – together with the study team – that Study Master File is being initiated, maintained and closed/archived
• Set-up and maintenance of study information in the Clinical Trial Management System as per delegation from the PM /CRA(s)
• Coordinates Study Supplies
• Assists in study reporting
• Ensures arrangement of internal and external meetings
• Takes actively part in study team meetings and is responsible for meeting minutes
• Assists in activities associated with audits and inspections
• Supports the study team in all regulatory processes (IEC/IRBs/CA) including submission of initial application and amendments
• Assists the study team in management of contracts such as site agreements, pharmacy agreements
• Manages Investigator Payments as delegated by PM/CRA(s)
• Supports the PM coordinating and handling translations in a project according to Scope of Work
• Supports CRA(s) with remote monitoring activities if applicable, including collection of documents, follow-up on data entry and query resolution
• Support the PM with Vendor Management
• Ensures delivery of projects on-time, within scope and within budget and in compliance with
  applicable quality standards.
• Manages the strategic aspects of studies and identifies, analyzes and minimizes/mitigates any risk, including the implications of different technical and operational choices.
• Develops and maintains Project Plans and timelines for their project and track progress.
• Ensures work of CTA is according to quality standards and within financial budget and timelines
• Ensures that all study team members are adequately trained on project specific systems and procedures
• Measures and evaluates project performance, if appropriate under guidance of more senior team member
• Reports and escalates to management as needed

Requirements

• Clinical research experience preferrably in Ophthalmology
  
• 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

TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the privacy notice for further details.

TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.