Project Management Associate

*
Responsible for supporting the Project Management group to ensure smooth and effective study delivery through organising of important documents and files.
Client Details
* European headquartered, pharmaceutical company with a mission to help patients with unmet medical needs.
Description
* Act as key stakeholder in the management of Trial Master Files (TMF)
* Lead the setup of TMF and track document progress.
* Ensure quality checks for study-related documents in TMF, adhering to GCP and SOP standards.
* Monitor document completeness and timeliness and share updates with the study team.
* Coordinate Clinical Trial Notifications (CTN)
* Establish a timeline for CTN submissions.
* Gather information for CTN and draft submissions, maintaining regulatory compliance.
* Handling JNDA/Inspection Tasks
* Prepare the necessary documents for submission to regulatory authorities.
* Assist in activities related to regulatory inspections.
* Initiate and maintain study document production, ensuring template and version compliance.
* Prepare appendices for the Protocol/Clinical Study Report.
* Oversee the timely customs clearance of medical devices, if applicable.
* Develop a list of required lab kits.
* Provide assistance to the study and SSU teams throughout the study phase, including document delivery and negotiation, document distribution and collection, and Site File and Worksheet preparation.
* Propose and implement plans to mitigate risks and address quality-related issues with essential documents.
* Contribute to ongoing improvement efforts, including enhancing study processes and other procedures.
Profile
*
Qualities of the Ideal Candidate:
*
Strong work ethic, professionalism, organisation, and attention to detail.
*
Team-oriented with the ability to maintain confidentiality.
*
Able to work independently with minimal guidance.
*
Experience in clinical operations in pharmaceutical or CRO industries.
*
Effective prioritisation of tasks with conflicting deadlines.
*
Good interpersonal skills and teamwork abilities.
*
Knowledgeable about GCP procedural documents related to study delivery.
*
Proactive in identifying and solving problems.
*
Demonstrates analytical thinking, adherence to standards, and teamwork skills.
*
Shows professionalism and mutual respect.
*
Possesses strong organizational and time management skills, attention to detail, and multitasking abilities in a fast-paced environment.
*
Exhibits leadership capabilities, including collaboration, commitment to customers, integrity, decisiveness, and promoting diverse viewpoints.
* Fluent in Japanese, business level English
Job Offer
Our client's mission is to provide life-changing therapies to patients with unmet medical needs.
You can join in this mission and contribute to helping the lives of those with severe unmet medical needs through development of orphan drugs and gene therapies.
Page Group Japan is acting as an Employment Agency in relation to this vacancy.