My client is seeking a candidate for a Clinical Operations leadership role, the Clinical Study Manager is responsible for executing on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials. In addition to exceptional project delivery, they seek strong analytical skill and leadership qualities that will influence our internal team and motivate our CRO partners.
Broad view of the departmental goals and sees the “ big picture” scientifically and strategically;
Regularly interacts with Clinical Affairs and company leadership on matters concerning clinical development status;
Devises efficient, effective clinical trial execution strategies; guides planning and execution of clinical studies, including management of study budgets / timelines and external vendor(s) management.
Efficient at clinical trial timeline and budget forecasting, using objective measures and tools to plan and communicate key clinical trial metrics;
Exceptional planning, communication, and creative problem solving skills, ensuring trial delivery for one or more clinical trials.
Leads by example and mentors other Clinical Operations team members, including employee development through company goal setting, performance management processes.
Ensures compliance of clinical trials with federal and applicable regulatory agency requirements.
Assists with development and implementation of policies and standard operating procedures (SOPs) to be used in Clinical Operations.
BS/MS in science or a health-related field.
4 - 6 years related work experience, at least 2 years in a study management role.
Biopharmaceutical (Sponsor) organization experience is a must. CRO experience is also desirable.
Demonstrated effectiveness in resolving study management issues;
Experience managing and training regional or consulting CRAs within project teams is required; direct line management is not required;
In-depth knowledge of the CRO selection and contracting processes;
Superb communication skills; effective in objective data interpretation and communication as well as expression of abstract ideas to all levels of the organization;
Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.