Position Summary
Enalare Therapeutic is looking to hire a Senior Manager of Clinical Operations, who will report to the Vice President of
Clinical Development to support both nonclinical and clinical research projects. The candidate is expected to be highly
organized with exceptional record keeping and communication skills. As part of a small company, the candidate will be
expected to work in a fast paced environment as a critical member of a cross functional team.
A candidate for this position will have a strong knowledge of clinical trial management, GCP/ICH guidelines and
documentation in drug development. The ideal candidate is high energy, self-motivated team player with the ability to
take charge on new responsibilities and adapt within an evolving work environment.
Responsibilities
Manage vendors in day-to-day activities to implement nonclinical and clinical projects, maintain regulatory
compliance and deliver results timely
Contribute to clinical project planning such as with assessments of resource and cost requirements
Provide critical reviews and feedback on study documents and reports
Assist with reporting and routine updates to granting agencies
Supports Regulatory Affairs/Quality Assurance with clinical content for submissions Contribute to vendor/site selection and identification
Interacts with key opinion leaders and therapeutic area experts and study staff
Oversee the operational approach and strategy for the implementation of clinical protocols, data collection
systems, electronic tools and final reports
Contribute to the development and implementation of stage appropriate departmental infrastructure and SOPs
as required
Focuses on continuous improvement, defining and implementing the changes required to optimize efficiency
and data quality.
Develops strong and productive working relationships with key stakeholders throughout the organization with
the ability to think strategically across a broad portfolio and effectively express his/her views to senior
management.
Requirements
5+ years of experience in oversight of clinical studies in a pharmaceutical or biotechnological environment, with work history demonstrating progressive increase in level and breadth of responsibility.
o CCRP or equivalent certification or can demonstrate equivalent experience / knowledge
o Advanced degree in a medical or medical science discipline a plus Proven experience achieving deliverables through collaboration with internal or external providers