Clinical Sciences Project Manager

GSK•Durham, NC

3d•Hybrid

About The Position

This unique role represents a great opportunity to join the ViiV Healthcare Global Collaborative Studies Group (CSG), which currently supports over 120 investigator sponsored research (ISR) studies, generating important evidence on our products, and for the field of HIV, across the world. This role involves developing, refining, and executing processes, risk management strategies, and other activities essential to the ongoing success of the CSG team and our ISR program. The role includes taking a leadership role in management and delivery of our Request for Proposal study process. It may also involve managing certain study related activities, a potential development opportunity for the right candidate. The optimal candidate will be self-motivated, with an innovative mindset and strong problem solving, digital and project management capabilities, a desire to support evidence generation across the ViiV portfolio and a passion for contributing to the ViiV mission of leaving no person living with HIV behind. The Primary Purpose of the role is to support the Global Collaborative Studies Group (CSG) in the review, execution and management of ViiV Healthcare (VH) supported studies such as investigator sponsored studies (ISS) and supported collaborative studies (SCS) by strengthening and implementing processes and ways of working to improve efficiency, communication of program outputs and study management activities.

Requirements

Life Science degree (MSc, PharmD, PhD, etc)
Pharmaceutical industry and/or clinical research experience
Understanding of clinical trial process from study concept to publication
Project management experience including the design, planning, governance, phasing and implementation of projects as well as tools and techniques for issues and risk management, decision making and reporting
Proficiency in multiple digital and software applications and ability to provide expertise and lead user capability

Nice To Haves

Knowledge of and experience in the HIV therapy area
Experience in managing multiple projects, including complex projects, in a matrix environment
Strong teamworking and relationship building skills with external and internal partners across multiple functional areas
Excellent written and spoken communication and able to effectively influence within team and across partner groups

Responsibilities

Support the CSG team, including Regional Investigation Leads (RILs), with study related activities and process management, such as budget and milestone monitoring and updating, risk management and tracking, and optimisation of processes for ensuring timely and compliant study review, progression and start up and study close out
Support prioritised evidence generation aligned to Integrated Evidence plans by generating regular updates on ISR study progress and publication plans
Optimise process for and lead central project management of Request for Proposal (RFP) study programs, in conjunction with project teams, RILs, external facing teams and Global Medical Operations as applicable
Work cross functionally with key internal stakeholders groups to ensure timely, compliant and efficient delivery of ViiV support for and communication of ISS and SCS. Key collaborators will include (but are not limited to): Medical Affairs (global, regional and local); Clinical Operations and Clinical Supply teams; Finance; Scientific Communications and Legal
Co-ordinate and support the development and implementation of training materials and programs for Study Accountable Persons (SAPs) and medical team members
Co-ordinate and support the execution of Global review and ISS update meetings, materials and minutes
To serve as SAP for specific studies including supporting life cycle and close out activities (mentored by senior CSG member) – potential development component to role, as applicable
Support use of and embed ViiV Enhance and appropriate project management and digital tools within CSG activities