Overview
We are looking for a Global Studies Asset Manager to lead and drive the operational study management delivery of one (or more) of our molecule assets.
This position holds responsibility for clinical operations management and execution.
Product Development's mission is to improve patients' lives around the world through unique medicines that have a meaningful impact.
Cross functionally we conduct global clinical trials, analyze results, monitor safety, and work with regulatory authorities to provide truly differentiated medicines to patients.
Our primary disease focus areas are Oncology, Hematology, Neurology, Immunology, Ophthalmology, Cardiovascular, Renal, and Metabolism (CVRM).
We attract, develop, and retain the most talented people in the industry, within PDG's Clinical Operations Country Footprint.
Responsibilities
Leverage PDG's Analytics and Portfolio Optimization (APO) and Clinical Operations Excellence (COE) expertise to support acceleration, enhance efficiency, ensure quality, and ensure a patient- and investigator/site-centric approach in study delivery
Co-ordinate and deliver the study management aspects of a group of studies within an asset's portfolio following ICH-GCP and Sponsor ´s processes in accordance with SOPs and guidelines to ensure the clinical study progresses as planned
Provide input into the development of essential study level documents (eg study protocol, TMP, Pharmacy manual).
Develops a studys recruitment expectations in partnership with APO, sponsor countries and the partner CRO and develops and maintains a forecast using the appropriate systems (EFT)
Develop and/or maintain or provide input in collaboration with CRO partners, study management essential documents (EG Pharmacy manual, relevant study plans/ relevant training materials (EG IMP management))
Drive innovation in clinical operations by thinking of and contributing to the implementation of new approaches in partnership with COE, APO and HBS in order to deliver outcomes that meet and exceed industry best practices.
Build and role model effective study partnership behaviors and mindsets with your TA aligned CRO partner to ensure we maximize the expertise of the CRO and our internal colleagues, minimising duplication of work and ensuring cost and resource efficiency for study(ies) in responsibility
Develop and oversee key performance indicators (KPIs, quality and operational) for areas of responsibility by using company tracking systems, including timely and accurate data entry in our systems, and proactively communicating any risks to timelines and/or quality, or identified quality issues, along with proposed mitigations to your Global Studies Leader
Maintain inspection readiness of the relevant components in scope of responsibility
Lead 3rd party vendor selection Vendor identification set up, and oversight and close out to ensure delivery to contract (in line with relevant iCOP strategies and study level needs)
Produce, arrange translation & distribute patient and site facing support materials
Manage supply and shipment of IMP
Obtain and distribute clinical trial insurance
Regularly seek and provide feedback to study team members on their individual performance to support their professional development and contribute to the achievement of a High Performing Organization.
Qualifications
Have a minimum 3 years of relevant operations experience (clinical trial management is a plus)
Hold a university degree or equivalent years of experience, preferred focus in life sciences
Possess strong working knowledge of drug development process and respective regulations, including ICH and GCP guidelines
A self-starter who finds passion in achieving successful outcomes
Want to make a difference and find excitement in innovating practices, products and processes
Have a growth mindset and are excited about learning through experience
Feel comfortable thinking on your feet and thrive in fast-paced, ambiguous and highly collaborative environment
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Learn more at
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.
All information and credentials submitted in your application must be truthful and complete.
Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law.
We appreciate your honesty and professionalism.
#J-*****-Ljbffr