Global Study ociate Director
Global Study ociate Director
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Job Description
Join Our Team as a Global Study Associate Director
TFS HealthScience is a leading global midsize Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full servicecapabilities resourcing and Functional Service (FSP) solutions.
About this role
The Global Study Associate Director is a businesscritical role within Study Managementwhose main accountability is the delivery of clinical studies.The Global Study Associate Directoris responsible for leading a crossfunctional study team and for providing the team withdirection and guidance to enable successful study delivery.
As part of our SRS team you will be dedicated to one sponsor a global patientfocused pharmaceutical company
Key Responsibilities:
- Lead provide guidance and delegate appropriately to a crossfunctional study team or overseeoutsourced delivery activities to ensure the clinical study progresses as planned drivingachievement of milestones according to timelines budget and quality standards. May holdaccountability and/or oversight of several studies.
- Lead and facilitate communication across all functions including external partners and serviceproviders. Lead and conduct investigator meetings and other study related meetings
- Ensure all external service providers (i.e. Contract Research Organizations (CROs) centrallaboratories IXRS ePRO etc.) engaged at the study level are performing to contracted goalsand timelines/budget and that adequate oversight is documented and any issues are escalatedappropriately.
- The GSAD is responsible for study budget reforecasting following initial budget estimateprovided by the CPT and accountable for study budget management through the study lifecycleand for providing budget progress reports to the CPT including any financial risks and mitigationplans (as part of the ongoing study change control process)
- Develop and maintain relevant study plans including required input into study level quality andrisk management planning (e.g. riskbased quality management proactive risk and contingencyplans etc.) ensuring that the risk response strategies and issue escalation pathways are clear tothe entire study team.
Qualifications:
- University degree (or equivalent) preferably inmedical or biological sciences or disciplineassociated with clinical research.
- 5 years of relevant clinical experience in thepharmaceutical industry including 2 yearsproject management experience or equivalent combination of education training and experience.
- Extensive knowledge of ICHGCP clinicalresearch regulatory requirements and
demonstrated abilities in clinical studymanagement processes and clinical/drug
development. - Demonstrated solid project management skillsand knowledge of relevant tools
Strong demonstrated abilities/skills in teamleadership
What We Offer
We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll 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 27 years ago in Sweden in the city of Lund. As a fullservice global Contract Research Organization (CRO) we build solutiondriven 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 decisionmaking 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.
Employment Type
Full Time
