Clinical Pharmacology and Translational Science (CPAT) Senior Study Manager

Summary about this job

Detail information about job Clinical Pharmacology and Translational Science (CPAT) Senior Study Manager. Terms and conditions vacancy

The Opportunity

The Clinical Pharmacology and Translational Science (CPAT) Senior Study Manager/Study Manager is responsible for/supports the on-time delivery of CPAT clinical studies, clinical operational planning activities and leading/supporting study execution of early stage clinical studies. The CPAT (Senior) Study Manager works closely with the Director of CPAT Operations and Program Manager (PM) and leads/supports one or more studies. The CPAT (Senior) Study Manager leads/participates the Study Execution Team (SET) and oversees study level outsourcing and takes preventive/corrective action(s) to address study level issues.

The CPAT (Senior) Study Manager may be required to co-monitor as needed. Key responsibilities to ensure study delivery include:

• Clinical project management of an ED clinical study

• Create and drive study level timeline

• Develop overall feasibility concept and enrolment plan with appropriate input from internal stakeholders

• Develop and manage study budget

• Provide input on operational aspects of the protocol

• Ensure regulatory compliance and Good Clinical Practice GCP compliance

• Responsible for oversight of Trial Master File TMF with periodic audits

• Responsible for/contribute to vendor selection and ongoing management and oversight of all outsourced activities

• Collaborate with vendors and internal stakeholders to ensure that data is available for review by the Safety Review Committee in a timely manner

• Collaborate with Clinical Supplies &Logistics team to plan and coordinate Investigational Medicinal Product (IMP) and non-IMP supplies

• Ensure monitoring plan is developed and consistently executed in collaboration with appropriate stakeholders

• Contribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and internal stakeholders

• Assigns and documents study specific roles and responsibilities to internal and external team members

• Ensure Clinical Operations team and external partner receive study specific training

• Report key study performance information, including study start-up metrics, enrolment, data collection timeliness/quality

• Facilitate study close out activities through completion of Clinical Study Report

To be successful  

Qualifications

At minimum, bachelor degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.  Other degrees and certifications considered if commensurate with related clinical research experience (e.g. diploma or associate degree RN, certified medical technologist).

Essential experience

•A minimum 5 years' relevant clinical research (or related) experience within the pharmaceutical industry.

•A solid understanding of the drug development process, and specifically, each step within the clinical trial process.

•Early Phase Clinical studies

•Experience in overseeing global clinical trials (pharmaceutical or research institute).

•Budget forecasting and management.

•Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.

•Ability to work independently with some oversight in the support and/or management of clinical trial execution.

The Company:

CSL Limited is a company that fosters a work culture emphasising Superior Performance, Innovation, Integrity, Collaboration and Customer Focus with a commitment to support, train and grow its people. As a genuine leader in the biopharmaceutical industry, CSL is a multinational ASX Listed Company that is actively growing its Australian based manufacturing operations to support global growth. CSL develops, manufactures and markets products to treat and prevent serious human medical conditions and is globally one of the largest manufacturers of plasma-derived therapies.

How to Apply:

Applications must address the selection criteria above and include a current CV and covering letter.

Applications close Friday, 3rd August, 2018

Employment screening, including criminal history, medical assessment, confirmation of experience and stated qualifications, Australian working rights and other relevant checks form part of the candidate suitability evaluation process.