- Responsible to plan, initiate, develop and organize clinical trials in accordance to the highest standards required in ICH E6 GCP, regulatory compliance, investigator integrity and compliance with the study requirements:
- Responsible for organization and management of project team and projects plans.
- Responsible for overseeing project execution and control activities.
- Responsible for planning, coordinating and managing the project in terms of resourcing, deliverables and timelines.
- Responsible to lead and motivate project team(s) on all project-related issues to ensure all activities are conducted in highest quality standards, in compliance with ICH E6 GCP and applicable local regulatory requirements as well as to meet/exceed sponsor’s expectation, under the supervision of project manager(s):
- Responsible for developing and executing quality management measure defined in Project Management Plan by defining project quality standards and requirements to ensure expected quality performance deliverables are met.
- Responsible for identifying foreseeable/ potential risks/ compliance issues which might affect the project quality standards, requirements and quality deliverables and proactively mitigating the risks/ non-compliance.
- Responsible for providing training to the project team members to ensure the project team is fully aware of the defined quality standards, requirements and expected quality performance deliverables.
- Responsible to supervise daily operations and management of activities associated with assigned project(s) from concept to completion of final study report and ensure project goals are achieved:
- Responsible for planning, coordinating and managing the project in terms of budget, quality, compliance, resourcing, deliverables and timelines.
- Responsible to ensure execution of appropriate communication channels and its documentation.
- Responsible to lead project team(s), sponsor and vendors, pertaining to logistics management, clinical supplies and investigational product logistics, systems set up and/or any other requirements, are in place to ensure swift study start up:
- Responsible to conduct project level meeting at the initiation of project.
- Prepare and maintain project matrix/ Gantt chart and review during vendor meetings. Manage scope of work and change in scope in consultation with the sponsor.
- Manage/support project(s) in the capacity of “Project Manager” (PM) and/or “Project Leader” (PL) to undertake all or partial responsibilities and tasks as designated by the Company
- Develop and oversee applicable clinical systems are accurately set up and maintained in a timely manner, to track the compliance, finance status and performance of the project and site(s) within project timeline, so as to report appropriately to sponsor and internal management:
- Responsible for establishment of project systems according to the project needs.
- Responsible for generating project reports and reviewing with internal project team members.
- Responsible for delivering project on time and within budget.
- Responsible to ensure that overall, appropriate project files are set up and maintained accurately and in a timely manner, to ensure compliance to ICH E6 GCP, applicable local regulatory and project requirements
- Coordinate and support/assist in Site and CRO audit or inspection as required:
- Prepare functions and project team for regulatory inspections
- Perform activities/ tasks to prepare for regulatory inspections.
- Oversee and guide project team members during inspection.
- Review responses to inspection observations
- Coordinate with HOD of specific functions, identify/ specify responses i.e. root cause, Corrective Actions and Preventive Actions (CAPA) along with timelines of resolution
- Implement CAPA action items
- Follow-up of inspection reports/ inspection observations
- Support Company’s operations by assisting/coordinating and conducting orientation and applicable training for new employees as required
- Support business development activities (e.g. project bidding, RFI, RFP) as required:
- Provide realistic budget estimation on the project-related expenses according to study assumptions upon Request For Proposal (RFP) in reference to ‘Project Plan Development and Execution’.
- Manage, monitor, adjust and control the total budget for each project throughout the entire project duration.
- Escalate to the management and sponsor whenever there is any scope creep and unforeseeable or unplanned expenses to be incurred.
- Compile additional budget from various parties, including project team, site personnel, contractors and/or vendors.
- Trigger BD Personnel to discuss with the sponsor to request for additional budget’s approval and prepare necessary Change Order (CO) or contract addendum with relevant parties, whichever applicable.
- Arrange project meeting to inform the additional budget or CO to relevant project team members including contractors and/or vendors whenever there is any CO.
- Review SOW on an ongoing basis and identify out of scope. Notify and work with BD personnel in the development of Change Order. Communicate with sponsor on Change Order. Assist BD personnel with developing and revising costing estimates, as necessary
- Review, revise and/or develop Project Management related SOPs, work guides etc:
- Responsible for the development, amendment, execution and maintenance of Project Management Plan which is used to manage and control the execution of the project.
- Min 5-7 years of experience in clinical trials/life sciences/clinical research experience
- Min Degree in Life Sciences or Life Sciences related
- Excellent communication skills
For interested candidates, please send your most recent and updated resume to [email protected]
Subject heading: Clinical Trial Project MgrJessie Wong Yuan Si
Recruit Express Pte Ltd
EA Licence No. 99C4599
We regret that only shortlisted candidates will be contacted.
Career LevelManagerQualificationBachelor’s Degree, Post Graduate Diploma, Professional DegreeYears of Experience10 yearsJob TypeFull-TimeJob SpecializationsSciences, Science & Technology
If you not find any contact details in this Job Description, Please attach your CV here and send directly.
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