Clinical Program Leader
An international pharmaceutical company is recruiting a Clinical Program Leader to their office in China. The organisation researches and develops scientifically defined and medically-proven skincare solutions by partnering with health care practitioners around the world. This is an exciting opportunity to work with a leading pharmaceutical company and provide real expertise to the position.
- Developing and compiling clinical strategies.
- Compiling study protocols, investigator brochures, and study reports.
- Compiling clinical documentation to support regulatory submissions.
- Supporting Clinical operation team to manage the clinical scope of study preparation and conduct, when applicable.
- Performing literature surveillance.
- Developing and reviewing publications and abstracts.
- Organising, contributing to, and/or participating in meetings with Investigators, CFDA, and other relevant internal and external parties.
- Collaborating closely with affiliate.
- Participating in the development and improvement of working instructions and routines.
- Keeping up to date on current regulations.
- Directing wide-ranging clinical projects.
- Participating in the clinical development strategy.
- Drawing up and/or validating certain CTD modules.
- Defining, drawing up, and/or validating the contents of the Briefing Package (BP), investigators' brochures, and submission files.
- Drawing up and/or validating replies to questions put by the regulatory bodies and other competent authorities.
- Presenting the development plan and the major phases/results of a project at external meetings.
- Contributing clinical expertise during meetings held to review projects/studies.
- Formalising and writing up reports or studies requiring reading, understanding, interpreting, and synthesising a large number of complicated documents, texts, and facts by developing and presenting ideas, arguments, and conclusions.
- Contributing to the planning process of complex and large-scale activities.
- Overseeing research on competitor products and the differential advantages of products.
- Maintaining awareness of company product side effects (pharmacovigilance).
- Identifying needs and passing on doctors' requests for information on products and medical practices to the relevant person.
Skills and Requirements:
- University degree in Medicine, Pharmacy, Biology, or Chemistry; preferably MD or even a PhD.
- Thorough knowledge of Good Clinical Practice.
- Thorough experience in clinical research (≥5 years).
- Thorough experience in medical writing (≥5 years).
- Experience from all parts of the clinical trial process, from protocol development to the compilation of study reports.
- Experience in compiling clinical documents to registration dossiers e.g. STED, CTD, PMA.
- Experience in supervising CROs.
- Experience as clinical project manager of clinical studies in major market(s) such as US and China.
- Experience in compiling Risk Management Reports according to ISO 14971.
- Experience in presenting to a scientific audience.
- 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.
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 Stephen Qin at +86 21 51694107 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.