Project Associate

2 weeks ago

Melbourne, Australia Avance Clinical Full time

**Core Responsibilities**
- Organise project systems set-up during the initiation phase.
- Draft Kick-Off Meeting materials & liaise with all stakeholders to facilitate the meeting.
- Draft project plans for review by the Clinical Project Manager (CPM).
- Maintain project information in the Clinical Trial Management System (CTMS), including project milestone tracking.
- Accurately track project action items, risks and issues from inception through completion.
- Organise, facilitate and take minutes for project/study team meetings.
- Liaise with a variety of different team members to ensure good communication across each study.
- TMF document review, metadata update and document approval.
- Facilitate quarterly reviews of the Trial Master File with the PM.
- Track vendor invoices, site invoices, and investigator grants payments on assigned projects. Supports assigned CPM with reviewing customer invoices for project labour and expenses.
- Assist the CPM with monthly revenue recognition and forecasting.
- KPI tracking and reporting to Sponsor.
- Monthly accrual generation and reporting to Sponsor.
- In-house site contact for tracking, shipping and maintaining drug/study supplies; query resolution, administrative protocol and study related questions

**Departmental Responsibilities**
- Foster the on-going commitment to maintaining a healthy team culture and promoting good morale, by actively participating in regular project management, Clinical Operations and PA team meetings.
- Identify training needs of the PA team and recommend to the SCPM appropriate training actions/programs.
- Ensure ongoing quality review of study documents (study documents, manuals and plans) as required including internal reviews of documents and forms.
- Proactively identify risks related to departmental service provision and assist in their mitigation/resolution in consultation with the SCPM.

**Qualifications, Skills and Experience**
- Bachelor’s level degree in life sciences, pharmacy, nursing or appropriate industry experience.
- CTA experience_ (desirable)._
- Familiarity with ICH/GCP guidelines, and country Regulatory guidelines _(desirable)._
- Excellent organisational and time management skills.
- Dynamic and action-orientated, with the ability to meet tight deadlines with a high degree of accuracy.
- Ability to communicate effectively with a wide range of people and to maintain confidentiality.
- Ability to set priorities, analyse problems, formulate clear and effective solutions and coordinate a number of tasks simultaneously.
- Willingness to work in and be supportive of positive and dynamic team culture.
- Intermediate to advanced skills in MS Office suite.

**Benefits**
- A challenging and stimulating environment where what you do matters
- A diverse and inclusive culture with a strong emphasis on team collaboration
- We genuinely value and care about each and every employee
- Training and career development opportunities
- Attractive remuneration

As we continue to grow, we want our people to grow with our organisation. We offer training and career development opportunities to build the skills and progress the careers of our employees.

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