Senior Project Associate
1 week ago
Avance Clinical is seeking a highly skilled Senior Project Associate to join our team. As a key member of our project management team, you will be responsible for planning and executing projects, coordinating staff and processes to deliver projects on time, within budget, and with the desired outcomes.
Key Responsibilities:- Support all aspects of project delivery from study commencement to completion, including establishing and configuring project management systems, processes, and trackers.
- Draft project plans for review by the Project Manager and maintain project information in the Clinical Trial Management System (CTMS).
- Accurately track project action items, risks, and issues, and lead internal and external project/study team meetings.
- Liaise with cross-functional team members to ensure good communication across each study and facilitate quarterly reviews of the Trial Master File (TMF) with the PM.
- Track vendor invoices, site invoices, and investigator grants payments on assigned projects and assist the PM with monthly revenue recognition and forecasting.
- Source, supply, and maintain drug/study supplies, and participate in study-specific or vendor audits conducted by sponsors or regulatory agencies.
- Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements and provide guidance and mentoring to less experienced project management staff members.
- Bachelor's level degree in life sciences, pharmacy, nursing, or equivalent field (highly regarded), or appropriate industry experience.
- Previous experience as a PA (or equivalent) in a CRO or Pharma company for at least 2 years, and working knowledge of ICH GCP Guidelines and applicable regulatory requirements.
- Clear understanding of the requirement to adhere strictly to client confidentiality and effective written and oral communications skills.
- Demonstrated ability to take initiative in problem solving and in exercising good judgment, and an understanding of Privacy Legislation as it applies to the Clinical Trial Environment.
- Ability to work under pressure in a multi-disciplinary team environment and willingness to work in, and be supportive of, a positive and dynamic team culture.
- Stimulating work and project diversity, with an intellectual challenge and an agile & flexible workplace.
- Opportunity to progress and stability, with a sense of community and a leadership team that are working together on a common goal.
- Flexible work options and great tools / tech to do your job, with a competitive salary & an extra day's holiday for your birthday.
At Avance Clinical, we empower cultural, disability, LGBTI+, and gender equality, and we encourage difference, it's celebrated and it's something we strive for.
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