【Alexion Japan】Clinical development Associate, R&D

Position Summary

 The Clinical Development Associate (CDA) contributes to Study Delivery with appropriate quality by having primary responsibility for essential document management and coordinate tasks that improve team performance from a wider perspective during the study process.

Principal Responsibilities

• Trial Master File (TMF) Management

　　　Initiate and lead the set up of TMF including tracking of documents.

• Implement of appropriate quality check of the study-related documents in TMF and check GCP and SOP compliance.
• Check the status of document storage (Completeness, Timeliness) and share the information to study team.

• Coordination of Clinical Trial Notification (CTN)

• Set a schedule of necessary actions for CTN submission
• Coordinate information collection for CTN and draft it and manage timing of CTN update for regulatory compliance.

• JNDA/Inspection

• Prepare index/documents required submitting to Regulatory authority.
• Assist in activities associated with regulatory inspections.

• Study documents/materials Management

• Initiate and maintain production of study documents, ensuring template and version compliance (e.g. Certificate of Insurance, Personnel list and other applicable study delivery document).
• Prepare the appendices for the Protocol/Clinical Study Report.
• Manage custom clearance of medical devices to time, if applicable.
• Develop Lab kit list

• Providing support to the study team including SSU team during entire study phase: including but not limited to CDA delivery and negotiation, distribution and collection of documents, Site File and Worksheet preparation, etc.
• Propose and implement risk mitigation plans and contingencies from identified essential documents quality related issue and potential issues.

• Contribute to continuous improvement activities, including study processes and other procedures.

Qualifications

The ideal candidate will have a strong work ethic, be professional, organized and detail oriented. This is a team-oriented position that plays an integral role in facilitating processes and procedures and ability to remain confidential is critical.  They will also demonstrate the ability to work independently with minimal direction.

• At least 2 years’ experience in pharmaceutical industries or healthcare organization.

• Ability to prioritize and manage multiple tasks with conflicting deadlines.

• Good interpersonal skills and ability to work in a team environment.

• Demonstrates sound knowledge of GCP and Alexion procedural documents as they pertain to study delivery systems and processes.

• Proactively identifies risks and issues and possible solutions.

• Demonstrates analytical thinking, concern for standards, concern for impact, good team skills including cooperation, willingness to learn from others, sharing of relevant information, adaptability, self-control, tenacity, conflict resolution skills, and the ability to influence others.

• Demonstrates professionalism and mutual respect.

• Displays good organization and time management skills, good attention to detail, and ability to multi-task in a high-volume environment with shifting priorities.

• Consistently exhibits Leadership capability as below

• Works Collaboratively: shares and seeks out diverse views, incorporating them where appropriate in order to develop better proposals and creative solutions for the business.
• Commitment to Customers &Integrity: Tailors products/services based on an understanding of customer needs, acting with integrity to drive business value.
• Acts Decisively: Makes independent/effective decisions that are guided by AZ values. Speaks up respectfully and works with persistence and energy to overcome obstacles.
• Works Collaboratively: Creates an environment in which diverse viewpoints are sought and encouraged, both within and beyond the team (e.g. with external partners).

Education

• Bachelor’s degree (or equivalent), preferably in biological science or discipline associated with clinical research.