Senior Project Manager; Midwest or West Coast

Senior Project Manager (Midwest or West Coast)

We are looking for a Sr. PM to join our team that is located in the Midwest or West Coast Regions of the US.

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 Clinicalisa Contract Research Organisationwhichoffersspecialised  servicessupportingdrug developmentforthe pharmaceutical and biotechnology industry.
The Senior Project Manager I (Snr PM I) 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 I 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 Planand 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 paymentmanagementand tracking.
• Review and/or oversee site budget and clinical trialagreementsdevelopment.
• 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 andparticipatein training initiatives.
• Other duties as directed by Line Management or delegate in line with skills,experience and/or qualifications.

Who are we?
We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development…