5+ years of experience managing global clinical trials in a CRO setting
Proven leadership and project management skills
Observational study experience is essential
Oncology experience preferred
Strong understanding of regulatory requirements (Good Clinical Practice, ICH guidelines)
Responsibilities
Lead project teams to deliver project milestones
Serve as the primary sponsor contact for study-related items
Develop and design project protocols and deliverables
Monitor project progress against established operational plans
Facilitate investigator meetings and budget negotiations
Supervise project management staff and ensure timely deliverables
Lead internal and external meetings to present project information
Benefits
Remote opportunities
Growth opportunities for promotion
401K with company match
Tuition reimbursement
Flexible work environment
Discretionary PTO (Paid Time Off)
Employee assistance programs
Medical, Dental, and vision coverage
Telemedicine availability
Wellness program
Adoption assistance
Short term and long term disability
Life insurance
Discount programs
Full Job Description
UBC is seeking an experienced Sr. Clinical Project Research Manager with 5 years of experience managing global clinical trials within the CRO industry. This person must have observational study experience. Oncology experience is preferred.
Job Title: YLM01I - Senior Clinical Project Research Manager
Brief Description: Lead UBC project teams to deliver project milestones
Specific Job Duties:
Serve as the primary contact with the sponsor for all study related items, with oversight of 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, the development of communication plans, monitoring plans, project plans, training plan, study timelines, Compliance Plan and 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)
Supervise all functional areas that support the project
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 positive attitude
Desired Skills and 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:
At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.
Here are some of the exciting perks UBC offers:
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
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About United BioSource Corporation
United BioSource Corporation is a leading provider of healthcare services and solutions. The company specializes in providing support for clinical trials, patient access programs, and post-approval research, helping pharmaceutical and biotech companies to bring new treatments to market more quickly and effectively. United BioSource Corporation has a global presence, with operations in North America, Europe, and Asia, and a team of over 1,500 professionals with expertise in a wide range of therapeutic areas. The company is committed to improving patient outcomes and advancing the field of healthcare through innovative solutions and collaborative partnerships.
