Clinical Project Lead
Diegem, Belgium
5 dagen geleden
source : Experteer

LI-EURClinical Project LeadAbout the opportunityThis is a great opportunity to join us as a Clinical Project Lead where you will be supporting our priority pipeline, which includes projects covering Rare Diseases, Biologics, Neurology and Oncology.

You will have responsibility for the set up and execution of clinical trial / study within Belgium, ensuring compliance with company quality standards and regulations in force, the forecasted timelines, milestones and budget.

You will represent the Belgium Clinical Study Unit and will work closely with the Regional Trial Manager, the global Clinical Trial Team (CTT) and other CSU colleagues to lead the monitoring teams (MT) for studies taking place in the country.

You will also represent the CSU at the Medical Affairs / Business Unit meetings to feedback on study progress.About growing with usIn this role you are accountable for set-up activities according to the company standards, regulations in force and country generic administrative timelines (submission to ECs / IRBs / HAs, approvals, contracts with sites, local AEDs), and that committed targets and timelines are met at all steps and until study completion (recruitment, active / inactive sites, deadlines for DMCs, DBL, closure of sites, archiving).

are the first point of contact for Regional Trial Managers (RTM), other global CTT members and the local monitoring teams.

Also, you are the first point of contact for Medical Affairs / Business Units for locally initiated studies, providing input to feasibility, study design and budget development and providing feedback on study progress.

organize kick-off meeting with local monitoring teams (MT), organize training of monitoring teams (study procedures, study devices, monitoring plan, ) and organize investigators meetings.

provide support to MT (protocol, monitoring plan, CRF, tools ) and prepare or arrange the preparation of protocols, written subject information, other essential documents, CSR, etc.

for studies initiated locally.ensure the preparation of local study cost request form within / across the countries, ensure the optimization of costs, and manages the country study budget.

You will also ensure the implementation of study IT systems in the countries (IVRS, ePortal) and adequate provisioning of devices and materials in the countries enough in advance.

participate in the revision / preparation of study progress tools (newsletters, ) and ensures CTMS are updated appropriately (e.

g. IMPACT, ClubNet, PRISMA etc.). source and manage service providers for studies initiated locally (e.g. Medical Writer, Statistician, Data Manager, Central Laboratory, CRO, etc.

oversee field monitoring activities through regular contacts with local MT (e.g. local CTT meeting), review of MVRs, check on monitoring tool compliance.

identify potential problems (risks) and ensure issues are solved with action plans in place (recruitment, study conduct / data quality, ).

ensure high quality level in data collection and queries resolution for the countries.conduct appropriate accompanied site visits and ensure preparation and proper response to audit / inspection reports and implementation of recommendations.

share lessons learned and ensure adequate deployment of possible identified action plans for improvement within / across the countries.

About youQualifications / Education & work experienceEducated to degree level in a science or medical speciality.A minimum of 5 years of professional experience in Clinical Development (e.

  • g. as CRA).Thorough working knowledge of all aspects of GCP and the regulatory / ethical framework pertaining to clinical trials;
  • Ability to plan, set and manage clinical trial budgets.Ability to learn and apply SOPs.Organization of local investigators meetings (contents, prioritization, model, .

  • Contingency plans aimed to meet forecasted timelines and targets.Ability to escalate non-performance and quality issues to local management, CQPTA (quality issues) and RTM.
  • Closure of inactive sites.CompetenciesAct for change, strive for results, cooperate transversally, commit to customers, make decisions, lead others through people / project management.

    Management, leadership, negotiation skills and communication skills, organizational, analytical and planning abilities, results oriented, quality preserving, be proactive and able to anticipate and resolve conflicts / issues, reactivity to emergent needs, able to prioritize, time management.

    Good IT skills in, e.g. MS Office, are essential, for planning, tracking, communicating and reporting.Languages : Fluent English, French, Dutch.

    Inspire your Journey, what Sanofi can offer youAn international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.

    An individual and well-structured introduction and training when you onboard.You can create your own career path within Sanofi.

    Your professional and personal development will be supported purposefully.As a globally successful and constantly growing company, Sanofi provides international career paths as well.

    This is our Sanofi, Discover yours.At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values.

    We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.

    We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.Full time

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