Clinical Operation Director Jobs

Department: Clinical Operations

Job Title: Clinical Operations Director

Report to: Clinical Operations VP (U.S)

Location: US (remote)

Responsibilities:

·Responsible and accountable for the conduct of clinical trials

·Oversee, lead and manage cross-functional teams and external service providers to conduct trials on time, on budget, in compliance and of high quality

·Coordinate and execute all operational aspects of clinical trials

·Identify and manage all external vendors, and escalate issues when appropriate, and make appropriate changes to ensure trial conduct is completed to meet company’s business objectives

·Ensure clinical trial team and clinical trial sites are properly trained

·Identify and engage with clinical investigators and site study related personnel

·Drive site selection and subject recruitment programs to deliver study enrollment targets

·Ensure the trial is “audit ready” at all times

·Perform oversight to ensure that adverse events /SAEs are properly tracked and reported

·Ensure all project level study documents are filed properly in the TMFs

·Proactively monitor and report trial progress, performance and financial metrics on an ongoing basis to management team

·Provide supervision to the clinical operations managers

Qualifications:

ØMinimum of 10 years’ experience in clinical research and 3-4 years management experience in related fields such as clinical operations (Minimum 5 years of monitoring experience in clinical research).

ØMaster’s degree or above in biological science, pharmacy, or other health related discipline.

ØClear and compelling communication.

ØStrong leadership and influencing skills across geographies and culture differences.

ØAdvanced ability to problem-solve and conflict resolution.

ØOperational expertise in risk management and contingency planning.

ØProven ability to manage budgets and resource.

ØExperience in international CROs preferred.