Global & Regional Studies Asset Manager - Sponsor Dedicated - Product Development

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).

The Global Studies Asset Manager (GSAM) is responsible for the consistent and efficient execution of global operations for a group of studies related to an asset, or within a Disease Area (DA) or Therapeutic Area (TA). This role involves working closely with internal teams and partner operations, as well as cross-functional experts and vendor partners, to ensure smooth operational delivery. As a vital member of the Extended Study Management Team (SMT), the GSAM provides operational delivery expertise to ensure consistency and efficiency across the assigned studies.

Job 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 (e.g. study protocol, TMP, Pharmacy manual).
• Develop a study's recruitment expectations in partnership with APO, sponsor countries and the partner CRO and develop and maintain a forecast using the appropriate systems (EFT).
• Develop and/or maintain or provide input in collaboration with CRO partners, study management essential documents (e.g. Pharmacy manual, relevant study plans/relevant training materials (e.g. 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 behaviours and mindsets with your TA aligned CRO partner to ensure we maximise 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 of 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.