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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.

Broad Purpose 
Avance Clinical is a Contract Research Organisation which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry. 
 
The Senior Project Manager II (Snr 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. The Snr PM II may also line manage a team of Project Associates (PA). 
 
Core Responsibilities  

• Autonomously manage the performance of all aspects of project delivery from commencement to completion, 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. 
  • 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. 
  • 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 Trial Master File (TMF) documentation to ensure accuracy and completeness as per SOPs. 
  • 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. 
  • Review study protocols and other study related documents. 
  • May act as a Lead PM on larger, more complex studies or those involving more than one region. 
  • 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. 
  • Provide guidance and mentoring to less experienced project management staff members and participate in training initiatives. 
• Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications. 

 
If applicable to the individual's role, also includes: 

• Monitor line reports' compliance with use of expected company systems and processes; training completion and timecard entry, leave entitlement administration, and expense processing. 
•  Actively manage the performance of line reports and individual career development strategies. 
• Support staff retention initiatives, drive staff recruitment (including interviews and probation period management) and manage staff severance. 
• Manage PA resource assignments across the department in conjunction with the Project Director team, proactively projecting PA resource need. 

 
Departmental Responsibilities 

• Foster the ongoing commitment to maintaining a healthy team culture and promoting good morale, by actively participating in regular Project Management Team meetings. 
• Maintain effective communication with other members of the department. 
• Proactively identify risks related to departmental service provision and assist in their mitigation and resolution. 
• Manage and track business related expenses as per company policy. 
• Proactively identify training needs of the Project Management Team, provide recommendations for, and lead or participate in delivery of appropriate training actions and programs. 
• Assist with the development of departmental SOPs as required. 

Qualifications, Skills, and Experience 

• Bachelor's level degree in life sciences, pharmacy, nursing, or equivalent field. 
• Previous experience as a PM in a CRO or Pharma company for at least 6-8 years. 
• Where applicable, previous PM-related line management experience is desirable. 
• Previous experience as a Clinical Research Associate (CRA) 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. 
• Willingness to work in, and be supportive of, a positive and dynamic team culture. 
• Ability to travel (desirable). Very minimal level of travel may be required (up to 10%). 
• Can build and maintain positive relationships with management, peers, and subordinates.  
• Ability to work independently or in a team environment as needed. 
• Display strong analytical and problem-solving skills. 

What we offer

• 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

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