[Hiring] Senior Project Manager @United Biosource Corporation

Role Description

Lead UBC project teams to deliver project milestones.

• Serve as the primary contact with the sponsor for all study related items, overseeing all aspects of project conduct from study start-up through close-out in accordance with company and project specific SOPs, guidelines, budgets, timelines, and contracts.
• Execute operational aspects of assigned project activities as well as special projects.
• Assist in the development and design of protocols, CRFs, regulatory documents, project master file, and other project related deliverables.
• Ensure operational plans are developed consistent with project needs, including but not limited to:
  • Development of communication plans
  • Monitoring plans
  • Project plans
  • Training plan
  • Study timelines
  • Compliance Plan
  • Clinical management plans
• Monitor project progress as compared to established plans and ensure compliance with plans.
• Facilitate and plan investigator meetings; recruit qualified investigators and assist in budget negotiations as required.
• Supervise APM/PMs and other team members to ensure project deliverables and timelines are delivered accurately and timely; provide reports to the Sponsor on project progress.
• Lead projects with cross-functional involvement and supervise all functional areas that support the project.
• Assist in revenue and invoicing for project(s).
• Ensure project training occurs and assist with training for project, as assigned.
• Serve as a resource to team members for all inquiries and issue resolution for site management, contract budget and remediation, and regulatory document preparation.
• Lead internal client teleconferences and/or meetings and present project information at client meetings, bid defenses, and UBC monthly project review meetings.
• Maintain project documentation to be “audit ready.”
• Support APM/PMs in sponsor/regulatory audits as required.
• Assist in preparation of client proposals in response to RFPs.
• Ensure project budget is tracked against contract milestones.
• May be asked to assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents as required.
• Initiate and lead process improvement activities.
• Accurate reporting and interpretation of project metrics.
• Proposal and implementation of action plans.
• Satisfactory delivery of contracted services and achievement of contracted milestones for assigned projects.
• Duties described for Project Manager and other duties as assigned by management.

Supervisory Responsibilities

• Supervision of project management staff in execution of assigned projects.
• Prepare PMs to make presentations to clients in defense of proposals.
• Ensure that the APM/PM understands the client needs once a project is awarded.
• Serve as a resource and mentor to the APM/PM in the execution of their daily activities.
• Proactively assist the APM/PM in anticipating and seeking resolutions to potential and actual project issues.
• Motivate project team members by fostering teamwork.
• Maintain a positive attitude.

Qualifications

• BA Degree or minimum 5 years of direct project management experience at a CRO or proven leadership/management experience.
• Excellent written, verbal, and non-verbal communication skills.
• Excellent supervisory skills.
• Excellent interpersonal skills.
• Excellent presentation skills.
• Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution.
• Solution driven.
• Manage competing priorities effectively.
• Very good knowledge of regulatory requirements (i.e., Good Clinical Practice, ICH guidelines, etc.).
• 10% travel.

Expected Project Load

• 2 to 3 projects depending on scope.

Benefits

• Remote opportunities.
• Competitive salaries.
• Growth opportunities for promotion.
• 401K with company match.
• Tuition reimbursement.
• Flexible work environment.
• Discretionary PTO (Paid Time Off).
• Paid Holidays.
• Employee assistance programs.
• Medical, Dental, and vision coverage.
• HSA/FSA.
• Telemedicine (Virtual doctor appointments).
• Wellness program.
• Adoption assistance.
• Short term disability.
• Long term disability.
• Life insurance.
• Discount programs.