Senior Project Manager (Midwest or West Coast)

Avance Clinical is a Contract Research Organisation providing specialised services that support pharmaceutical and biotechnology drug development. The Senior Project Manager is responsible for planning and executing clinical trials, coordinating stakeholders and study teams, managing timelines, budgets, risks, documentation, and regulatory compliance. The role may also provide line management, mentoring, resource planning, and departmental support.

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
• 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
• Foster the on-going 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
• Identify training needs of the Project Management Team, provide suggestions for, and support delivery of appropriate training actions and programs
• Assist with the development of departmental SOPs as required
• Participate in internal Quality Assurance activities as required, including responding to audit findings
• Embrace the core values of Avance Clinical and endeavor to display those attributes at all times with clients and staff alike
• Commit to Avance Clinical training programs
• Adhere to Avance quality systems
• All staff are required to take reasonable care for their own health and safety and that of other personnel who may be affected by their conduct

Requirements:

• 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 3-5 years
• 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
• Very minimal level of travel may be required (up to 10%)
• Where applicable, previous PM-related line management experience is desirable
• Previous experience as a Clinical Research Associate (CRA) is highly regarded
• Ability to travel (desirable)