Similar posts
Clinical Study Manager (SH/NJ)
This vacancy has now expired. Please see similar roles below...
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.
#LI-TT1
#ClinicalResearch
Related jobs
Highly Competitive
Basel, Schweiz
Are you looking to make an impact with your innovation? We are working with a well-established pharmaceutical company to recruit for a dedicated Associate Director!
Highly Competitive
Tokyo, Japan
Looking to escape your long commute to work? Unlock your new remote working position with this exciting role!
Highly Competitive
Thüringen, Germany
Proclinical betreut derzeit eine spannende Gelegenheit bei einem etablierten Pharma-Unternehmen in Thüringen
Highly Competitive
Cambridge, USA
Proclinical is seeking a Senior Director of Medical Writing to oversee and lead clinical and regulatory medical writing initiatives at our client's Cambridge, MA facility.
Highly Competitive
Berne, Switzerland
Proclinical hat sich mit einem führenden Schweizer IT-Beratungsunternehmen zusammengeschlossen.
US$205000 - US$214000 per annum
Washington Grove, USA
Ready to shape the future of clinical statistics? Step into a pivotal leadership role as Director of Biostatistics with one of our forward-thinking clients.
Highly Competitive
Basel, Schweiz
Ready to lead the analysis of drug products? Join our client at the forefront of pharmaceutical innovation and make a difference!
Highly Competitive
City of London, England
Are you a dedicated individual looking to put your expertise to work fully flexibly in a remote position?
Highly Competitive
Aalen (73433), Deutschland
Wir suchen einen erfahrenen Softwareentwickler (m/w/d), der innovative Lösungen für Fertigungs- und Messtechniksysteme entwickelt und so die digitale Transformation im Produktionsumfeld vorantreibt.
US$25 - US$30 per hour
Norton, USA
Proclinical is on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world.