healthcare,life science,clinical development,trial execution,clinical research,global drug development process
Your responsibilities include, but are not limited to:
- Lead and develop the Trial & Medical Operations team: Ensure staffing, training and development of (Sr.) Clinical Project Managers and (Associate) Clinical Operations Specialists. Accountable for talent and career development of direct reports, including performance management to meet the operational demands of CONEXTS.
- Create & develop local processes to implement the End to End Clinical Trial Service strategy – collaboration with counter-part in other CONEXTS sites or countries is essential to ensure service consistency across location.
- Provide sound leadership and superior decision making support as well as services’ experience and process excellence to drive quality service implementation, cost optimization and continuous improvement in the CONEXTS full service offering.
- Build on existing Novartis processes or develop new processes to provide guidance to the clinical trial teams to ensure that industry best-practice standards in operational and performance excellence are met and customer expectations are met or exceeded. Where necessary, develop and implement operating procedures to ensure regulatory compliance.
- Drive improvement in performance of service quality, turnaround time, customer feedback and other key performance measures and benchmark against best-in-class.
- Establish robust relationships with other CONEXTS Operations teams, understanding the needs of stakeholders to identify potential service opportunities or improvements in service processes.
- Oversee and report progress against CONEXTS’ Post Launch Scientific Support objectives whilst ensuring adherence to timelines and budgets.
- Provide clinical operational input to activities related to planning, execution and reporting of clinical trials to support clinical trial management.
- Relevant educational background in life sciences/Healthcare (Ideally a Bachelor’s Degree or above in life sciences) or equivalent combination of education, training and experience, with strong knowledge of clinical development and trial execution.
- Approximately 10 years’ of clinical research experience, including clinical trial management experience, with solid knowledge of global drug development process.
- Approximately 4 years’ of people management experience, this may include people management in a matrix environment.
- Excellent understanding of clinical trial methodology, GCP and medical terminology. Advanced planning and tracking skills with attention to detail. Well-organized, excellent time management with respect to priorities and self-management.
- Strong management, interpersonal, communication, and problem solving skills. Quick action taker. Involves the right team members in the right situation at the right time.
- Ability to mentor, coach associates, and to coordinate interactions with internal and external partners. Superior people management skills with demonstrated positive leadership, innovative, and collaborative behaviors.