Clinical Study Manager (SH/NJ)

A leading pharmaceutical company that accelerates the launch and listing of drugs across China is seeking a Clinical Study Manager to join their office in Shanghai. The organisation, which is a subsidiary of an international pharmaceutical corporation, specialises in increasing China's core competitive power in the innovation of new drugs. This is an exciting opportunity to work with a prestigious company that develops first-class drugs.

Job Responsibilities:

• Leading and managing a cross-clinical delivery sub team to operationally deliver defined clinical studies or clinical project activities.
• Leading the operational delivery of clinical studies, via a team of contributing experts from the study specification to the final clinical study report and archived master file.
• Providing input into study feasibility and study specifications and producing essential documents, including the authoring of clinical study protocols across both interventional and non-interventional studies.
• Working across studies or project work package, ensuring consistency across the development program.
• Acting as the interface to partners and oversee the delivery to plan of studies performed through external partners (such as Alliance partners, CROs, vendors and Academic Research Organizations) and to monitor progress, identify and solve operational issues.
• Leading/contributing to clinical submission assembly, regulatory response, and payer evidence teams and contributing to advisory board and steering committee meetings.
• Managing changes to project scope and costs (including CRO and other vendors change orders) and reporting project status by participating in project planning, control activities, and generation of status reports as required.
• Agreeing with the project team and functioning the most efficient procedures to support delivery by taking the project situation and compliance requirements into account.

Skills and Requirements:

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
• At least 5 years' experience from within the pharmaceutical industry or similar organization or academic experience.
• Extensive knowledge of clinical operations, project management, and processes.
• Good experience of clinical development/drug development process in various phases of development and therapy areas.
• Project management certification is desirable but not mandatory.
• Evidence of developing partnering skills.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Tom Tan at +86 21 51694101 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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