Global Study ociate Director

2 months ago

Ottawa, Canada TFS HealthScience Full time

Join Our Team asa Global Study AssociateDirector

TFSHealthScience is a leading global midsize Contract ResearchOrganization (CRO) that partners with biotechnology andpharmaceutical companies throughout their entire clinicaldevelopment journey. Our expertise includes fullservicecapabilities resourcing and Functional Service (FSP)solutions.

About thisrole

The Global Study AssociateDirector is a businesscritical role within Study Managementwhosemain accountability is the delivery of clinical studies.The GlobalStudy Associate Directoris responsible for leading acrossfunctional study team and for providing the team withdirectionand guidance to enable successful studydelivery.

As part of ourSRS team you will be dedicated to onesponsor a global patientfocused pharmaceuticalcompany

KeyResponsibilities:

  • Leadprovide guidance and delegate appropriately to a crossfunctionalstudy team or overseeoutsourced delivery activities to ensure theclinical study progresses as planned drivingachievement ofmilestones according to timelines budget and quality standards. Mayholdaccountability and/or oversight of severalstudies.
  • Lead and facilitate communicationacross all functions including external partners andserviceproviders. Lead and conduct investigator meetings and otherstudy related meetings
  • Ensure all externalservice providers (i.e. Contract Research Organizations (CROs)centrallaboratories IXRS ePRO etc.) engaged at the study level areperforming to contracted goalsand timelines/budget and thatadequate oversight is documented and any issues areescalatedappropriately.
  • The GSAD is responsiblefor study budget reforecasting following initial budgetestimateprovided by the CPT and accountable for study budgetmanagement through the study lifecycleand for providing budgetprogress reports to the CPT including any financial risks andmitigationplans (as part of the ongoing study change controlprocess)
  • Develop and maintain relevant studyplans including required input into study level quality andriskmanagement planning (e.g. riskbased quality management proactiverisk and contingencyplans etc.) ensuring that the risk responsestrategies and issue escalation pathways are clear tothe entirestudyteam.


Qualifications:

  • Universitydegree (or equivalent) preferably inmedical or biological sciencesor disciplineassociated with clinicalresearch.
  • 5 years of relevant clinicalexperience in thepharmaceutical industry including 2 yearsprojectmanagement experience or equivalent combination of educationtraining and experience.
  • Extensive knowledge ofICHGCP clinicalresearch regulatory requirementsand
    demonstrated abilities in clinical studymanagementprocesses andclinical/drug
    development.
  • Demonstratedsolid project management skillsand knowledge of relevanttools
    Strong demonstrated abilities/skills inteamleadership

What WeOffer

We provide a competitivecompensation package comprehensive benefits and the opportunity forpersonal and professional growth in a rewarding environment. Youllbe joining a team that values collaboration innovation and making adifference in the lives ofpatients

A Bit More AboutUs

Our journey began over 27 yearsago in Sweden in the city of Lund. As a fullservice global ContractResearch Organization (CRO) we build solutiondriven teams workingtowards a healthier future. Bringing together over 800professionals TFS delivers tailored clinical research services inmore than 40 countries with flexible clinical development andstrategic resourcing solutions across key therapeutic areasincluding Dermatology Neuroscience Oncology andOphthalmology.

Our core values of Trust QualityPassion Flexibility and Sustainability are our guiding lightserving as the framework for decisionmaking at all levels of theorganization. They assist us in attracting and retaining valuabletalent who share our sentiments resulting in high employeeengagement and satisfaction. By aligning on these fundamentalvalues we cultivate a unified force geared towards innovation andexcellence. This collective effort propels us towards our sharedgoal and fosters a culture of mutual respect and collaboration.Together we make adifference.

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