Biotech outsourced - Associate Director Clinical Operations - Netherlands
IQVIA Holdings Inc.
In this role you will be fully outsourced to one of IQVIA's niche biotech clients, working on a portfolio of Oncology, Hematology and Autoimmune Rare Disease studies, mostly in Early Phases. We look for someone who is motivated by science and loves working with new therapies in complex disease areas.
The position reports into the Medical Affairs Director, and indirectly to the international Executive Director Clinical Operations.
The Associate Director, clinical operations (ADCO) responsibilities include leadership and local strategic planning and operational delivery of assigned clinical trials to support the pipeline, in accordance with the appropriate quality standards, including ICH/GCP/GPP standards, SOPs, local operating guidelines and local requirements, as applicable. The ADCO works locally toward Global Operational targets for recruitment and completion of R&D sponsor trials within timelines and budget. In addition, the position requires management of local CRAs and local oversight of vendors.
- Has accountability and oversight for all assigned studies at country level
- Provides support to Clinical Research Associates (CRAs) by setting clear goals and expectations, monitoring performance, providing overall motivation, support, feedback and follow-up to ensure team performance is fully optimized
- Plans and executes country study goals and commitment, and ensures compliance
- Collaborate closely with Medical Affairs team
- Representing the country and research Associates and provides Global team with feedback
- Working with the Study Start-up team, ensures timely submission of all regulatory, ethical and administrative submissions.
- Oversees study feasibility and site monitoring performance
- Collaborate with Global Study Team to develop and execute local risk management plans
- Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections
- Develops, builds and maintains optimal relationships with key institutions within the country,
- Ensures that clinical data from sites are delivered in accordance with established dataflow, timelines and quality.
- Leads and/or organizes and/or participates in local or regional meeting and training sessions to implement country level recruitment plans
- Makes an active contribution to therapeutic area strategy teams ensuring knowledge sharing of local interest.
- Manages issues related to local invoices and provide oversight of any budget reconciliation, in collaboration with Finance department.
- If appropriate, review CRO monitoring plans and training plans for studies conducted in the country
- Bachelor’s degree with 5-7 years of experience in Clinical Trial operations in pharmaceutical / biotechnology industry or CRO, including at least 3 years in a role of primary responsibility for clinical trial execution and management.
- Dutch & English speaker
- Understanding of Dutch regulatory processes
- Thorough understanding and experience in global/Regional clinical trials in oncology.
- Good knowledge and experience of working with CROs
- Matrix supervisory experience.
- Must be able to travel (domestic and international) up to 10%
Please get in touch by clicking the apply button, or by emailing email@example.com.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.