シミックグループは日本初のCRO（Contract Research Organization：医薬品開発受託機関）として、自由な発想と先見性で、医薬の世界に新たなサービスを生み出してきました。現在では医薬品開発だけでなく、製造、販売まで、製薬企業の全てのプロセスを支援するサービスを提供しています。30周年を迎えた現在、個人のヘルスバリューを高めるために新たな挑戦のステージに入っています。従来のビジネスを武器に事業拡大していく中で、グループ横断的に様々なプロジェクトやタスクが複数開始される予定です。
1. Undertake the role of Project Manager for designated project(s) and be responsible for overall project management from every aspect to ensure all deliverables are met and client is satisfied with the service delivery and results.
2. Support in operations and/or business's continuality by undertaking tasks such as:
- Mentoring and training of new employees as require
- Support business development activities
- Review, revise and/or develop Project Management related SOPs, work guides etc
RESPONSIBILITIES AND DUTIES:
1. 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
2. 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.
3. 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.
4. 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.
- Complete and provide ‘Vendor Feedback Form’, detailing the reviews of CMIC team and sponsor assessment at the end of project.
5. 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
6. 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.
- Ensure that the project reports are shared with Sponsor (If applicable).
7. Support and/or conduct monitoring and co-monitoring activities, as required (Preferably)
8. Support/assist in feasibility studies, site and investigator identification as required (Preferably).
9. 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
10. 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
11. Support Company's operations by assisting/coordinating and conducting orientation and applicable training for new employees as required
12. 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 CMIC 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.
- Prepare, reconcile, analyse and report project financial performance and associated key performance indicators at predetermined intervals to the sponsor and/or to CMIC management.
- 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
13. 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.
REQUIRED EDUCATION AND QUALIFICATIONS:
1. Minimum bachelor degree (major in nursing, pharmacy or other bio-science-related background) from a recognized institution, and/or equivalent combination of training and experience
2. Certificate in basic and advanced GCP course, in the applicable countries, or the equivalent internal training records
3. Certificate in advanced monitoring and/or project management courses
4. Has experience in a pharmaceutical/biotechnology setting including development of pharmaceutical products and/or medical equipment. Has in-depth knowledge/understanding of clinical development.
1. Minimum 4 years’ experience in clinical research in healthcare, pharmaceutical and/or CRO industry, or minimum 3 years direct experience in clinical project planning, coordination and management, with multi-national trial exposure
2. Has experience in clinical study monitoring and co-monitoring (Preferably)
3. Experience in coordination and preparation for site/CRO/Regulatory authority audit (Preferably)
Interested parties please apply to:
|職種 / 募集ポジション||Associate Clinical Project Manager※Singapore|
|会社名||シミックホールディングス株式会社／CMIC HOLDINGS Co., Ltd. (HQ)|
|創業 / Foundation|| |
1992年（会社設立：1985年3月14日) In 1992 (The Company was established on March 14, 1985)
|代表者 / Representative Directors|| |
代表取締役CEO 中村 和男 / Kazuo Nakamura, Chairman and CEO 代表取締役COO 大石 圭子 / Keiko Oishi, President and COO
|従業員数 / No.of Employees|| |
7,878名（連結子会社含む）※2022年5月現在 7,878 (as of April 1, 2022 on a consolidated basis)