Clinical Trial Manager, Qpex BioPharma, wholly-owned subsidiary of Shionogi Inc. in San Diego, CA.

The Clinical Trial Manager will be an integral member of the Development Team at Qpex Biopharma and will be responsible for the successful execution of domestic and international clinical trials.

Key

Responsibilities

Responsible for the design, planning and implementation of clinical trials, including collaborating with cross-functional teams to design clinical trial protocols.Develop detailed trial plans, including timelines and budgets; track trial expenses and manage the overall study level budget.Negotiate site contractual agreements and participate in CRO selection, site selection and Investigator’s Meetings.Serve as the primary contact for the CRO and oversee field monitoring and data management activities, as well as coordinate activities with contract laboratories; manage trial deliverables and CRO performance.In collaboration with the CRO oversee operational study level feasibility, recruitment and retention strategies and the delivery of the study protocol.Track and review regulatory documents, manage drug supply, and process serious adverse eventsWrite and maintain Standard Operating Procedures. Support development and improvement of departmental procedures according to latest practice.Lead or support inspection readiness activities. Participate as appropriate in internal and external audits.Establish and maintain effective communication and collaboration with functional area peers in order to meet program objectives, proactively identify study risks and support achievement of goals.Mentor project team members regarding project specific activities, reporting and tools.Other

duties as assigned.

Supervisory

Responsibilities

Ctm Will Have Supervisory

responsibilities over Clinical Research Associates (CRAs)

Qualifications

Bachelor’s degree in Life Sciences, Nursing or Pharmacy.Minimum of 6 years’

experience in the pharmaceutical industry or clinical research organization as a clinical research associate with project

responsibilities in initiating clinical trials in the US and internationally.Detailed knowledge of current Good Clinical Practices is required, and knowledge of regulatory

requirements is a plus. Strong interpersonal and communication, problem solving and organizational

skills and ability to manage multiple projects.

Experience Managing Cros And

experience designing and reviewing case report forms, edit specifications, and query resolution.Ability to lead projects of diverse scope, analyze data and exercise sound judgment along with the ability to recommend business alternatives to senior management.Knowledge of pharmaceutical business, drug development and regulatory processes.Proficient MS Office

skills including Microsoft ProjectClinical project management

experience in infectious diseases is preferred.Ability to travel (approximately 10%).

To be considered for this position, you must apply and meet the

requirements of this opportunity.

We Look Forward To Reviewing Your Resume &

Qualifications.

The Base

salary range for this full-time position is $130,000 - $150,000 annually. This

salary range is an estimate and may vary based on the Company’s

compensation practices.

Disclaimer

The job description is not designed to cover or contain a comprehensive listing of

requirements,

duties or

responsibilities that are required of the employee. Other

requirements,

duties and

responsibilities may change or be assigned at any time with or without notice.

Eeo

Qpex Biopharma Inc. is an

equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job

requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable law.

It is the policy of Qpex Biopharma Inc. to undertake affirmative action in compliance with all federal, state, and local

requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.