Clinical Supply Manager
6 month contract
£32.80ph via UMB
My Client is looking for a Clinical Supply Manager to provide operational and project management support to the Clinical Supply Leads.
This person will also be responsible for Supporting Drug Supply Strategy and overarching Supply Project Management related activities under a high regulated governance and compliance environment, for Clinical Supply Team and program.
Supporting team to ensure no interruption in therapy, ‘fit for supply’, ‘fit for distribution and storage’, ‘fit for Medical Professional and Patient Use’.
· Provide operational support to the clinical supply process, while working to a core set of activities according to GSK/VH operating standards and GxP for ViiV Global Sponsored and Supported R&D Trials, Phases I - IV
· Real time maintenance, tracking and oversight of 2-3-way facing communication tools used to support multiple (internal and external) IMP matrix functional activities, including reporting data pulls for stakeholders and matrix parties, to meet business needs to ensure delivery of results
· Ensuring accuracy and integrity of data in clinical supply systems and communication tools (including, GSK Supply Chain, Regulatory/CMC asset data, 3rd party vendors, transfer of value (TOV), IMP finance.
· Supports Secretariat to the Drug Strategy Committee (DSC), to ensure accurate and timely IMP planning, monitoring, execution and oversight of clinical studies.
· Serves as point of contact for study support questions for internal teams and customers for assigned study(s)
· Responsible for audit readiness, integrity of data in systems at program level, forecast modeling and tracking tools, invoice tracking and accuracy and resolution of issues, including report and resolution of findings
· Archiving documentation, quality checked and tracked
· Ad-hoc project work as required to support operational supply team and systems.
Oversight, budgeting, forecasting and financial acumen
· Knowledge of clinical supply, global regulatory requirements in accordance with cGMP regulations GCP regulations, ICH guidelines as it relates to Good Distribution Practices (GDP).
· Due to many functions’ involvement with a wide breadth of complexities, the role requires a high level of problem-solving skills and judgement to manage many competing priorities
· Proactivity identifying and supporting strategies for continuous improvements, across multi-function teams/matrixes. Capacity to recommend, contribute, and lead agile strategic execution on improvement initiatives.
· understanding of clinical trial project management, including oversight plans, supply mitigation, risk assessment and audits.
· Experience in clinical trial material and supply agreements, service level agreements.
· Experience in third party relationship management and oversight and ability to establish and maintain mutually respectful, productive, trusting collaborative relationships with third-party vendors.
· Proven ability to work in fast-moving and dynamic environment, including ability to adapt and manage competing demands, changes in approach to best fit the situation and deal with frequent unexpected events.
· Strong organizational skills, demonstrates accuracy and thoroughness, highly analytical, problem-solving skills and synthesizes of complex or diverse information and resolution orientated and attitude.
· Excellent communication, listening and interpersonal skills; demonstrate complex data in understandable and accessible manner to non-technical audience.
· Strong team player and contributes to building a positive resilient team spirit. Actively contributes to team effort, including ability to train, mentor others and build wellness to tasks.
· Experience in change management and/or implementing systems will be an advantage
· Experience in HIV clinical research in diverse geographic regions, with awareness of cultural, regional challenges and considerations.
· Ability to work in dynamic environment, strategic, tactical, and able to educate/influence multiple partner groups and stakeholders.
· Knowledge of supply chain operations, document control
- Demonstrated ability and willingness to develop new skills as required. Self-starter capable with a proven track record of using initiative and following through
High proficiency in Microsoft applications (esp Teams, excel modelling and forecasting/planning modelling), GSK systems including Power BI, Xpress, IdeaPoint. IRT experienced, will be an advantage.
If you feel you would be suitable for the role of Clinical Supply Manager, then please send in your application using your most up to date CV