Clinical Project Director
A leading biopharmaceutical company is seeking to recruit a Clinical Project Director to their office in Shanghai. The organisation is devoted to the development of a new generation of innovative drugs and prides itself on its broad immune-oncology pipeline. This is an exciting opportunity to join a leading organisation.
- Accountable for the implementation, management and reporting of assigned clinical trials.
- Leading the execution of the clinical studies in conformance with Good Clinical Practices (GCP) and in accordance with the International Conference of Harmonization (ICH) Guidelines.
- Key member of the clinical project team working closely with the Medical Leader and other key functions.
- Accountable for all aspects of assigned study execution including where applicable, CRO selection, study plan design, execution, study start-up, CRO and vendor management and performance, study budget and timelines.
- Developing all study plans in collaboration with the CRO.
- Managing all aspects of clinical operational plan.
- Ensuring the successful completion of clinical studies that are on time and within budget.
- Accountable for ensuring all needed aspects of clinical operations are identified (drug, resources, contracts, budgets, etc) and planned in timely manner.
- Generating contingency plans where necessary, proactively identify potential issues/risks and mitigate.
- Managing and monitoring the performance of all CROs and vendors to ensure the successful completion of program regarding timelines and budget.
- Managing the budget, contract requirements, and performance metrics for the team to ensure that trials/development program plans are on target.
- Working with DM to develop data capture tools that reflect the requirements of the protocol.
- Reviewing clinical data and metrics to identify trends.
- Developing mitigation plans as necessary.
- Reviewing and approving clinical supply and dispensing design and drug labels.
- Liaising with CRO on Investigational Review Boards (IRBs) and Ethics Committees (ECs) requirements and questions.
- Reviewing and contributing to key study documents including protocols, case report forms (CRFs) and informed consent templates.
Skills and Requirements:
- Bachelor's degree in Life Sciences, Pharmacy or Life Sciences. Advanced degree preferred.
- At least 10 years of experience working in industry and/ or with a CRO is required -managing clinical studies.
- Must be able to work collaboratively with others both internally and externally. Oncology experience preferred.
- Good working knowledge of GCP and ICH guidelines.
- Title and compensation commensurate with qualifications and experience.
- Proactive and organised with exceptional follow-up.
- Anticipate/ identify problems and takes appropriate action to correct.
- High degree of accuracy with attention to details.
- 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 is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.