Job Description:
We are seeking an experienced and skilled Associate Project Manager to join our team. In this role, you will be responsible for overseeing the management and coordination of assigned studies, ensuring compliance with relevant regulations and standards.
* Develop and maintain in-depth knowledge of assigned studies, including review, assessment, and management of sites, vendors, study-specific documents, development/review, and assessment of country-specific documents.
* Lead clinical trial activities for assigned studies, collaborating with external stakeholders and sponsors as required.
Main Responsibilities:
1. Manage and coordinate assigned studies, ensuring timely completion and quality standards are met.
2. Serve as primary contact for Sponsor and collaborator groups for assigned studies and disease-specific sup groups.
3. Provide training and mentoring to junior staff members as needed.
4. Contribute to preparation for audits and inspections as required.
5. Ensure overall responsibility for management of essential documents and Trial Master File where applicable.
6. Identify potential issues and proactively manage resolutions to minimize risks associated with assigned studies.
7. Ensure compliance with all applicable SOPs for all assigned studies.
8. Contribute to departmental and cross-functional SOP development and updates as required.
9. Organize, participate in, and present at meetings and discussions with other teams and team members.
10. Support the management of an assigned disease-specific sup group (DSSG) as DSSG coordinator, including coordinating meetings, supporting group activities, and helping to develop the trial portfolio.
Required Skills and Qualifications:
* Science or medical background with previous experience in medical or clinical research.
* Proven ability to deliver project goals and mentor junior-level employees.
* Excellent communication skills with the ability to represent the organization at a national level.
* In-depth knowledge of the Irish clinical trials environment is an advantage.