What You'll Be Doing:

• Act as primary liaison between Premier Research and the customer, chairing project team meetings; work strategically with clients to ensure understanding of study and corporate objectives, ensuring team alignment on timelines, milestones, and objectives

• Ensure cross functional management and coordination of the project team, including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and project delivery per client goals and Premier Research requirements

• Ensure high quality project plans align with client study and corporate objectives; maintain and update study plans; manage quality, risk, and contingency planning throughout the study; monitor deliverable quality and address issues with appropriate team members; oversee documentation to keep Trial Master Files audit ready; support audits and respond to audit reports

• Ensure adherence to project budget and scope to realize profitability; review/approve expenses and address contractual and budgeting issues; provide accurate information for timely invoicing and forecasting; identify scope changes and secure Change Orders; prepare staff utilization forecasts for the study

• Manage and resolve project related conflicts with corrective/preventative actions, alerting senior management to potential issues; review and recommend adequate resources to meet deliverables and milestones; ensure transition planning and communication for staff changes; identify, recruit, and manage central vendors as required

• Assist Business Development, including leading proposal presentations with Business Development and Scientific Account Leadership; facilitate team training (therapeutic, protocol specific, process); provide performance feedback for annual appraisals; mentor junior staff (Associate Project Managers, Project Specialists) and less experienced PMs in Business Development activities

• May travel up to 25%​

What We Are Looking For:

• Bachelor's degree, or international equivalent from an accredited institution, preferably in a clinical, biological, or science-related field

• 8-14 years trial management experience in a pharmaceutical company/medical device company/CRO, including 5-8 years' experience serving in a Project Leader role

• Advanced budget/finance/costing experience on both a project and portfolio level; experience in coaching/mentoring other PMs

• Strong experience managing complex trials, multiple phases, and full lifecycle, with global project management experience; experience presenting at bid defenses and investigator meetings

• Expert knowledge of ICH/GCP regulations; advanced working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures; expert knowledge of project management principles and the clinical development process

• In depth therapeutic area and protocol knowledge required in Immunology, Rheumatology, or Dermatology​​