Description
Our client is a multinational pharmaceutical company and is looking for a clinical trial delivery lead. The clinical trial delivery lead will be accountable for the delivery of the clinical study. This project will take place in Walloon Brabant for 6 months.
Scope of work:
The Study Delivery Lead (SDL) is the single accountable person for the execution and delivery of the study to time, budget (costs and resources) and quality as defined in the Clinical Development Plans and study protocol.
The SDL works in duo with the Clinical Development Manager (CDM) who is responsible for the medical and scientific aspects, design of the protocol and scientific outputs including data interpretation and reporting.
He/She will be the point of reference for planning, operational feasibility and delivery of their assigned studies from commit to study idea until publication. She/he coordinates expert input from clinical and non-clinical functions at study level.
The Study Delivery Lead (SDL) ensures the study is delivered with quality, in accordance with ICH/GCP and other regulatory requirements
The scope of work includes leadership, oversight and project management of global, local activities as well as activities outsourced to CROs/vendors.
* Accountable and responsible for execution and delivery of study as defined by protocol and according to agreed timelines and budget set in the Clinical Development Plan:
o Lead clinical and non-clinical functions to ensure study delivery and take key operational decision at study level (will refer to Project Delivery Lead as needed).
o Develop study plan and forecast, including detailed budgets, milestones quality and risk plans.
o Define resource requirements and ensure appropriate resourcing (including outsourcing).
o Track delivery to time, cost and quality, including maintenance of standard tools such as iPlan and eTrack.
o Ensure appropriate study oversight including study kick off meeting(s), regular TC with LOC/CRO, review protocol deviations, escalation process and ensure appropriate follow-up actions are taken.
o Set up of dashboard, regular review of trial monitoring tools (TMTs), key risk indicators (KRIs), key performance indicators (KPIs) and other study related reports/tools.
o Establish study performance reporting tools and communicates progress to Project Delivery Lead.
* Lead and oversee operational activities in study design and study execution including:
o Give strong input to concept protocol and protocol development to ensure optimal operational design and feasibility, and co-ordinate study execution plan health check.
o Accountable for the study feasibility. Coordinate country-level operational input to study feasibility.
o Select countries (ensuring efficient use of resources, adherence to GSK and Project requirements and according to defined resourcing strategy) and define recruitment target.
o Ensure appropriate training of country staff and sites on operational matters.
o Ensure delivery on time of quality documents (concept protocol, protocol ), plans (monitoring and communication plans...) and ensure core operational package is complete for submission.
o Ensure functional strategy and plans are developed, maintained and executed including clinical supplies, sample management, data management, document management and quality
o Accountable for the patient recruitment. Collaborate closely with the Recruitment lead.
o Ensure reviews and follows up protocol deviations.
o Provide input into vendor management activities including selection; responsible for Study-level oversight, communications and issue management.
o Provide input to the clinical study report/module appendix.
* Lead the given Study team and communication/escalation related to studies:
o In partnership with the Clinical Development Managers (CDM), lead and engage all members of the study network to ensure the appropriate experts (both central and local, operational and medical/scientific) are involved at appropriate stages and outputs are delivered on time.
o Manage study communications and issue escalation within the team, and communicate progress/performance and escalate issues to the Project Delivery Lead when appropriate.
* Ensure the study is delivered with quality, in accordance with ICH/GCP and regulatory requirements and take appropriate actions accordingly if necessary.
Requirements:
* University Scientific Degree (Master) in a general Science or Life Science Degree (Pharmacy, Chemistry, Bio Engineer, Biology, Biomedical Sciences).
* Significant erience (preferably more than 8 years) in managing clinical research studies, clinical operations or equivalent. Experience in clinical research is a must!
* Has a very good understanding of the clinical research and clinical trial management, associated with regulatory, processes and quality requirements.
* Given the nature of the job, the associated responsibility, the need to coordinate multi-disciplinary teams in the development of a clinical trial, a good scientific background associated with operational skills is preferred.
* Strong project management skills, including scope, budget, time-line, and resource planning and management, and use of associated tools and support where available.
* Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others.
* Demonstrates an excellent understanding of the clinical study/drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs.
* Able to set and manage priorities, performance targets and project initiatives in a global environment.
* Operational expertise in risk management and contingency planning.
* Demonstrates conceptual, analytical and strategic thinking.
* Effective at problem solving and conflict resolution.
* Fluent French & possesses excellent English language, written and verbal communication skills in addition to proven negotiation skills.
* Advanced presentation skills.
* In-country CRA/monitoring/sites experience is an asset.
* Complex job, requiring good problem solving skills and ability to address the varied issues arising in the preparation and development of studies.
* Enterprise thinking mindset and transversal approach required, considering the complexity of the role in managing multi-functional groups and representation of operations in various audience.
* Ability to evolve in changing and challenging environment.
* High pressure on deadlines.
Keywords:
Clinical trial, clinical study, clinical project manager, GCP, ICH, good clinical practices, clinical research