Shanghai Clinical Project Manager
An international pharmaceutical company is recruiting a Shanghai Clinical Project Manager to their office in Shanghai. The organisation provides leadership in support of healthcare concerns and partnership in matters regarding globalised drug research, development, and delivery. This is an exciting opportunity to work with a company that continues to expand across the Asian market and bolster a career in the clinical field.
- Working with the Business Development Department and/or Key Client Management Department to finalise the project budget and scope.
- Acting as a key contact for the Sponsor and Project(s) and establish and maintain good relationship with the Sponsor.
- Leading, managing, and communicating with multi-functional teams on regional or global interdisciplinary projects/studies to ensure on-time, and within budget deliverables for projects.
- Managing one or more projects concurrently.
- Managing projects as Project Director or Project Manager to meet Company and Sponsor's requirements and satisfaction. This includes managing resources, budgets, milestones, timelines, and quality.
- Planning, initiating, developing, and organising clinical trials in accordance to the highest standards required in the good clinical practices, regulatory obligations, investigator integrity, and compliance with study protocols and procedures.
- Assessing project resource requirements on a continual basis to ensure appropriate resources are allocated.
- Working and coordinating directly with both pharmaceutical and biotechnology companies (collectively refers to sponsors) with overall responsibilities for managing the budget, timelines, and qualities of all aspects of the assigned clinical trials/projects.
- Working closely with sponsors to oversee the implementation of project specific procedures and requirements to ensure that the study goals and expectations (on-time, on-budget, quality performances) are met.
- Resolving and recommending solutions and managing any deviations from plan or budget.
- Setting up, maintaining, executing, and implementing project-related documents, dossiers and files, project databases, project timelines, and processes, as well as tracking systems or other tracking/analysis tools for Sponsor and Management.
- Reviewing, finalising, and approving all study-related regulatory and administrative documents (including investigator study budgets and contracts) from investigator sites, monthly client/site invoices, monthly monitoring reports, work progression reports, and other documents.
- Planning, coordinating, and providing leadership in regular study team meetings and presenting at the Investigator's meetings, site initiation meetings and/or site close-out meetings
- Supervising and assessing the performance of line staff whenever applicable, as well as motivating, training, and developing line staff's expertise to ensure efficient and effective day-to-day work tasks as well as to achieve targets.
- Working with the Project Management Head to support business development activities or tasks as assigned by Business Development Department, Key Client Management, and/or the Company.
- Identifying specific training needs and supervise, training, and mentoring project team/clinical research staff within the company on project related policies, procedures, project management tracking tools, and other relevant SOPs.
- Measuring and keeping track team overall performance indices against projected baselines, timeline, and milestones.
- Ensuring that all project work is completed and delivered to sponsor's requirements and satisfactions.
Skills and Requirements:
- Bachelor's degree, majoring in nursing, pharmacy, or other science-related background from a recognized institution, and/or equivalent combination of training and experience.
- Minimum of 6 years of experience in clinical research, with at least 6 years prior experience in managing projects.
- Advanced knowledge of ICH-GCP guidelines, local GCP guidelines, and regulations in the region.
- Advanced understanding of cross-functional processes, clinical trial processes, and the regulatory environment.
- 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 Mandy Fang at M.Fang@proclinical.com.sg 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.