Project Manager II
Full time
at Avance Clinical Pty
in
Online
Posted on April 1, 2024
Job details
Join our expanding business. Experienced Project Manager required - exciting growth opportunity. Flexible location. CRO experience preferred,
11th March, 2024
Project Manager II – location is flexible. You can work from one of our four offices (Adelaide, Brisbane, Melbourne, Sydney) or work remotely from anywhere in Australia. Who are we? We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field. Why should you join Avance Clinical? We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success. We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future. The role The Project Manager II (PM II) is responsible for planning and executing clinical trials by coordinating study team members and processes to deliver projects on time, within budget and with the desired outcomes, ensuring the trial is conducted in accordance with the protocol, Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements. Core Responsibilities include- Manage the performance of all aspects of project delivery from commencement to completion, under the supervision of the Project Director and PM line manager, including:
- Coordinate the activities of internal and external stakeholders including the Sponsor, third party vendors and site staff to execute projects within agreed timelines.
- Maintain effective Sponsor communication to proactively manage project timelines, expectations, risks, and issues. o Prepare or review Ethics Committee submission documents, as required.
- Develop all study plans and documents to support the effective execution of all Project and Clinical Operations activities. o Identify, evaluate, control, communicate, review and report risks in relation to a project and its critical processes/data.
- Ensure protocol deviations are identified, documented, and reviewed in line with study plans.
- Review and Quality Control (QC) check Trial Master File (TMF) documentation to ensure accurate and timely filing as per SOP requirements.
- For a single-site study, oversee and lead the operations of the clinical team, develop the Clinical Monitoring Plan and review Monitoring Visit Reports.
- Effectively manage project financial performance of assigned projects, including revenue recognition, forecasting and contract management, sponsor invoicing, site payment management and tracking, vendor payment management and tracking.
- Review and/or oversee site budget and clinical trial agreements development. o Review study protocols and other study related documents.
- Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.
- Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.
11th March, 2024
Project Manager II – location is flexible. You can work from one of our four offices (Adelaide, Brisbane, Melbourne, Sydney) or work remotely from anywhere in Australia. Who are we? We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field. Why should you join Avance Clinical? We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success. We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future. The role The Project Manager II (PM II) is responsible for planning and executing clinical trials by coordinating study team members and processes to deliver projects on time, within budget and with the desired outcomes, ensuring the trial is conducted in accordance with the protocol, Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements. Core Responsibilities include- Manage the performance of all aspects of project delivery from commencement to completion, under the supervision of the Project Director and PM line manager, including:
- Coordinate the activities of internal and external stakeholders including the Sponsor, third party vendors and site staff to execute projects within agreed timelines.
- Maintain effective Sponsor communication to proactively manage project timelines, expectations, risks, and issues. o Prepare or review Ethics Committee submission documents, as required.
- Develop all study plans and documents to support the effective execution of all Project and Clinical Operations activities. o Identify, evaluate, control, communicate, review and report risks in relation to a project and its critical processes/data.
- Ensure protocol deviations are identified, documented, and reviewed in line with study plans.
- Review and Quality Control (QC) check Trial Master File (TMF) documentation to ensure accurate and timely filing as per SOP requirements.
- For a single-site study, oversee and lead the operations of the clinical team, develop the Clinical Monitoring Plan and review Monitoring Visit Reports.
- Effectively manage project financial performance of assigned projects, including revenue recognition, forecasting and contract management, sponsor invoicing, site payment management and tracking, vendor payment management and tracking.
- Review and/or oversee site budget and clinical trial agreements development. o Review study protocols and other study related documents.
- Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.
- Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.
- Bachelor’s level degree in life sciences, pharmacy, nursing, or equivalent field.
- Previous experience as a PM in a CRO or Pharma company, or previous exposure to project management skills in a clinical trial-related service provider.
- Previous experience as a Clinical Research Associate (CRA) prior to being a PM is highly regarded.
- Previous training and a working knowledge of ICH GCP and applicable regulatory requirements.
- Clear understanding of the requirement to adhere strictly to client confidentiality.
- Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.
- Demonstrated ability to take initiative in problem solving and in exercising good judgment.
- An understanding of Privacy Legislation as it applies to the Clinical Trial Environment.
- Ability to work under pressure in a multi-disciplinary team environment.
- Ability to travel (desirable). Very minimal level of travel may be required (up to 10%).
- Stimulating work
- Project diversity
- An intellectual challenge
- An agile & flexible workplace
- Opportunity to progress
- Stability
- Sense of community
- A leadership team that are working together on a common goal
- Flexible work options
- Great tools / tech to do your job
- A competitive salary & an extra days holiday for your birthday!
- To join our team please submit your CV & cover letter as one Microsoft Word document
- You must have full Australian working rights to be considered
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