United BioSource Corporation

REMS Project Manager

United BioSource Corporation$90K — $120K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree or equivalent experience
  • Previous managerial or relevant experience
  • Strong written, verbal, and non-verbal communication skills
  • Excellent supervisory and interpersonal skills
  • Proficient presentation skills
  • Critical judgment and problem-solving abilities
  • Solid understanding of regulatory requirements (e.g., Good Clinical Practice, ICH guidelines)

Responsibilities

  • Oversee project conduct from start-up to close-out
  • Execute operational aspects and manage project activities
  • Track project revenue and budget against milestones
  • Coordinate meetings and prepare documentation
  • Serve as primary contact with sponsors and stakeholders
  • Lead project training and supervise team members
  • Develop and track key metrics for project progress

Benefits

  • Remote work opportunities
  • Growth and promotion potential
  • 401K plan with company match
  • Tuition reimbursement for continued education
  • Flexible work environment
  • Discretionary Paid Time Off
  • Comprehensive medical, dental, and vision insurance
  • Employee assistance programs
  • Wellness program and telemedicine access
  • Adoption assistance and life insurance
Full Job Description
Job Title: YLM01H - Clinical Project Research Manager

Brief Description: Plan, organize and lead UBC project teams to deliver projects based on client needs on time, on budget, and within scope

Specific job duties:
  • Oversee all aspects of project conduct from start-up through close-out
  • Execute operational aspects of assigned project activities as well as special projects
  • Manage project per the scope of work and within the contracted budget
  • Manage revenue and invoicing for project(s)
  • Ensure project is conducted according to UBC SOPs and client SOPs as applicable
  • Develop plans and processes to achieve contracted milestones (e.g. project plan, clinical management plan, monitoring plan, training plan, communication plan, compliance plan); monitor project progress against the established plans and ensure compliance with plans
  • Prepare project timelines and prepare or coordinate development of deliverables
  • Prepare project meeting agendas and create minutes and actions logs
  • Ensure project budget is tracked against contract milestones
  • Serve as UBC primary contact with sponsor
  • Coordinate and facilitate all project meetings with internal and external stakeholders as necessary
  • Focal point for resolving project team member questions
  • Supervise all functional areas that support the project
  • Lead projects with cross functional involvement and supervise all functional areas that support the project
  • Ensure project training occurs and assist with training for project, as assigned
  • Develop content and lead Kick off Meetings both internally and externally
  • Negotiate budgets and assist with remediation of contract language
  • Present project information at bid defenses, client meetings and UBC monthly project review meetings
  • Maintain project documentation to be "audit ready"
  • Participate in sponsor/regulatory audits as required
  • Coordinate investigator meeting as required
  • May be asked to assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents as required
  • Help lead process improvement activities
  • Establish, implement and track key metrics to report on progress of project and initiatives
  • Coordinate and ensure maintenance of Trial Master File as required
  • May be asked to perform CSS and CRA duties as needed
  • Other duties as assigned by management

Supervisory Responsibility: Supervision of project team

Desired Skills and Qualifications:
  • Bachelor's Degree or equivalent experience
  • Previous managerial, or relevant experience, required
  • Very good written verbal and non-verbal communication skills
  • Very good supervisory skills
  • Very good interpersonal skills
  • Very good presentation skills
  • Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution
  • Solution driven
  • Very good knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)
  • 10% travel as required

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

#LI-JM1

#LI-REMOTE

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.
Learn more about United BioSource Corporation
Size
1,500 employees
Industry
Net Income
$20 million
Founded
2003
5 Year Trend
+10%
Revenue
$300 million

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