Associate Project Manager

1 month ago

Søborg, Denmark TFS HealthScience Full time

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 practicesActively contributes to the organization and development of processes to enhance the work at TFSPerform tasks as outlined below based on delegation by the line manager and / or project managerSupports 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 appropriateSupports 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 PlanEnsuring – together with the study team – that Study Master File is being initiated, maintained and closed/archivedSet-up and maintenance of study information in the Clinical Trial Management System as per delegation from the PM /CRA(s)Coordinates Study SuppliesAssists in study reportingEnsures arrangement of internal and external meetingsTakes actively part in study team meetings and is responsible for meeting minutesAssists in activities associated with audits and inspectionsSupports the study team in all regulatory processes (IEC/IRBs/CA) including submission of initial application and amendmentsAssists the study team in management of contracts such as site agreements, pharmacy agreementsManages Investigator Payments as delegated by PM/CRA(s)Supports the PM coordinating and handling translations in a project according to Scope of WorkSupports CRA(s) with remote monitoring activities if applicable, including collection of documents, follow-up on data entry and query resolutionSupport the PM with Vendor ManagementEnsures 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 timelinesEnsures that all study team members are adequately trained on project specific systems and proceduresMeasures and evaluates project performance, if appropriate under guidance of more senior team memberReports and escalates to management as needed

 

Requirements

Clinical research experience preferrably in Ophthalmology
Bachelor’s Degree and/or equivalent work experience preferredKnowledge of GCP/ICH guidelinesGood written and communication skillsGood organizational and multi-tasking skillsGood software and computer skillsAble to work in a fast-paced environment with changing prioritiesIntuitive, proactive team playerEffective time managementStrong Customer service orientationProblem 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.


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