Clinical Trial Manager/Senior Clinical Trial Manager

San Diego, CA - USA

Monthly Salary: $ 125000 - 175000

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Overview

Qpex Biopharma is seeking a highly motivated Clinical Trial Manager or Senior Clinical Trial Manager to oversee the execution of Phase I-III clinical studies from start-up through close-out. This individual will be a key member of our Clinical Operations team working closely with internal teams CROs and vendors to ensure studies are delivered on time within budget and in compliance with GCP and regulatory requirements.

Detailed Description

Essential Duties and Responsibilities

Responsible for operational execution of global/regional Phase I-III clinical studies.

Manage day-to-day execution of clinical trials including timelines budgets vendors and CRO oversight.

Lead study start-up activities such as protocol development site selection contracts and essential documents.

Serve as the primary contact for CROs vendors and clinical sites.

Monitor trial progress ensuring adherence to protocol GCP ICH and regulatory requirements.

Oversee the development negotiation and management of clinical contracts with vendors ensuring appropriate scope budget alignment and compliance.

Delegate and manage tasks and responsibilities to other team members assigned to the study/studies.

Provide review and input of clinical study documents (protocol operational plans monitoring plans monitoring visit reports) based on SOP ICH/GCP guidelines and with patient centric view.

Identify risks and develop proactive mitigation strategies. Escalate issues to stakeholders as appropriate and ensure successful implementation.

In collaboration with cross-functional team facilitate ongoing data review in preparation for interim final analyses and review of CSR.

Establish and maintain effective communication and collaboration with functional area peers in order to meet program objectives and goals.

Ensure high-quality clinical trial data and inspection readiness.

Participate in SOP development as reviewer of local or global documents. Support development and improvement of departmental and company procedures and share best industry practice.

Mentor project team members regarding project specific activities reporting and tools.

Other duties as assigned.

Qualifications

BA/BS in life sciences or equivalent; 5 years of clinical research experience including at least 2 years as a Clinical Trial Manager (for CTM) or 5 years in a CTM role (for Sr. CTM) having effectively led a study/studies project from inception to completion coupled with demonstrated ability to hold team members accountable. Global experience of drug development ideally obtained in a biotech/pharma setting.

Working knowledge of Good Clinical Practices (GCP) and FDA regulations and guidelines with respect to clinical trials and applicable international regulatory requirements. Awareness of EU Clinical Trials Directive / Regulation and expectations for MHRA GCP Inspections.

Knowledge of clinical operations project management tools and processes. Ability to effectively manage interactions with investigators and cross-functional team ensuring cooperation for achieving program goals.

Knowledge of pharmaceutical business drug development and regulatory processes.

Ability to resolve problems and lead projects of diverse scope analyze data and exercise sound judgment along with the ability to recommend business alternatives to senior management.

Excellent organizational communication and leadership skills.

Ability to work in a fast-paced dynamic environment.

Proficient MS Office skills including data review analysis tools.

Occasional travel including possible international travel.

Additional Information

The base salary range for this full-time position is $125000 - $175000. Individual pay is determined by several factors which include but are not limited to: job-related skills experience and relevant education or training. The range does not include the comprehensive benefits bonus long-term incentive applicable allowances or any additional compensation that may be associated with this role.

EEO

Qpex Biopharma is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race color religion sex (including pregnancy) marital status national origin age ancestry citizenship disability genetic information status as a disabled veteran a recently separated veteran Active Duty Wartime or Campaign Badge Veterans and Armed Forces Service Medal Veterans or any other characteristic protected by applicable law. It is the policy of Qpex Biopharma to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal state and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are in fact non-discriminatory.

If you are qualified individual with a disability or a disabled veteran you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling or by sending an email to

Required Experience:

Manager

OverviewQpex Biopharma is seeking a highly motivated Clinical Trial Manager or Senior Clinical Trial Manager to oversee the execution of Phase I-III clinical studies from start-up through close-out. This individual will be a key member of our Clinical Operations team working closely with internal te...