Main purpose
This position is an outsourcing position to one of the top 10 pharma companies located in Brussels.
The Clinical Operations Lead (COL) is part of the passionate, collaborative, Global Clinical Operations community! We act as one mutually accountable community focused on work that will have the highest impact on our core mission of helping patients across the industry’s most robust Development Portfolio. We recognize the individuality and diversity of everyone, the potential of all our people to learn, grow, develop and achieve great things beyond the confines of traditional job titles and job descriptions. We believe in reducing hierarchy and silos to enable teams closest to the work to deliver impact for patients. We empower and enable people to flow to outcomes-based work that they are most passionate about and where there is the most impact in moving towards our Pharma Vision. We believe every individual should have a self-directed, personalized career journey where personal fulfillment meets company purpose. Every individual has access to and can choose a trusted advisor, advocate, and/or coach.
Responsibilities
- To contribute to a combination of sub-communities that comprise the larger Clinical Operations Community, participate in or lead Work Product Teams and enable clinical trial delivery with a focus on delivering value for patients, investigators, and clinical site staff
- Drive patient-centricity (mindsets, behaviours, and actions) throughout clinical operations.
- Drive evolution of global clinical operations
- Inspire and empower talent
- Proactive stakeholder management and alignment
- Promote and support quality and compliance
Tasks
- Contribute to the delivery of the PD portfolio of clinical studies and programs across Disease Areas by providing operational and/or strategic input to the teams. Additionally, you may help architect the Disease Area Operational Strategy to enable trial execution and deliver a better future for patients by contributing to Company’s Personalized Healthcare mission of ensuring the right treatment for the right patient at the right time.
- Contribute and enable innovative clinical trial delivery and address emergent, high-impact needs that arise across multiple Disease Area Communities to enable more efficient, seamless clinical trial delivery for patients, investigators, and clinical site staff.
- Contribute to one or more of the many geographies that comprise global Clinical Operations so that PDG operates as one larger community. You may serve as a partner to local internal and external stakeholders in the country and help support local business needs.
- Cultivate meaningful peer-to-peer collaborations to drive a deeper understanding of the patient, investigator, and clinical site staff needs across PDG and beyond. In doing so, nurture a culture of curiosity to enable faster, simpler, and more patient-centric ways of operationalizing our studies.
- Creating, supporting, and embedding radically simpler ways to do highimpact work. This includes successfully delivering Clinical Operation’s portfolio of studies and/or enabling projects.
- Working with colleagues across Clinical Operations and the Company family to promote communication and community in a global matrixed environment. Optimizing growth opportunities and capabilities to successfully contribute and operate in a diverse and global environment. Drive new thinking by identifying new opportunities and options to embrace value creation.
- Collaborating influencing and partnering with many important stakeholders and colleagues across Company including Product Development, Early Development, Diagnostics, Commercial, and our Affiliates as well as external Industry Collaboration Bodies, Investigators, and Clinical Site Staff, Patient Advocacy Groups, and Key Vendors.
- Being accountable for GCP/GVP compliance, data integrity, and taking a balanced risk-based approach in the work you are focused on, seeking guidance or direction as needed.
Job criteria
Degree in life science, preferably higher vocational education or academic degree
Preferably at least 3 year experience in (international) clinical research
Fluent in English, Dutch and French; another European language is an asset
Microsoft Office (Outlook, Word, Excel, PowerPoint), internet; any experience with CTMS, eCRF systems is an advantage
Excellent knowledge of ICH-GCP and all applicable regulatory requirements
- Talented and passionate human
- Believer of the principles of Customer-Centricity, Human Centricity, Growth mindset, Enterprise view and Diversity and Inclusion
- You thrive in environments of ambiguity and collaboration where authority is distributed between all of the people involved and where advice seeking is foundational.
- You apply your organizing and problem-solving skills to plan and run efficient operational and enabling aspects of Clinical Operation’s programs, studies, and/or enabling projects.
- You are an effective communicator that shares information transparently and strategically. You are comfortable working out loud and are an active listener.
- You thrive leading or being an active member of large or small diverse teams.
- You find passion in achieving successful outcomes by inspiring others.
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