REMS Project Manager

United Biosource Corporation; United States; Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Remote opportunities

Growth opportunities

401K with company match

Flexible work environment

Discretionary PTO

Paid Holidays

Employee assistance programs

Medical, Dental, and vision coverage

HSA/FSA

Wellness program

Adoption assistance

Short term disability

Long term disability

Life insurance

Job summary

United Biosource Corporation (UBC) is seeking a REMS Project Manager to lead clinical project teams remotely across the US. The role focuses on delivering REMS and related programs on time, within budget, and to scope, while coordinating with sponsors and stakeholders.

You will manage start-up to close-out activities, budgets, invoicing, and compliance, and you’ll lead cross-functional project efforts with a focus on process improvements and audit readiness.

Qualifications

• Bachelor’s Degree or equivalent experience.
• Previous managerial or relevant project leadership experience.
• Solid knowledge of regulatory requirements (GCP, ICH).
• Excellent written and verbal communication.

Responsibilities

• Plan, organize and lead project teams to deliver on time, budget, and scope.
• Oversee start-up through close-out of clinical projects and REMS activities.
• Manage budgets, revenue, and invoicing for projects.
• Coordinate sponsor communications and governance meetings.
• Ensure audit readiness and regulatory compliance.
• Lead cross-functional teams and drive process improvements.

Skills

Strong communication

Supervisory skills

Interpersonal skills

Presentation skills

Risk assessment

Critical judgment

Education

Bachelor’s degree or equivalent

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

REMS Project Manager

Regular Research & Clinical Remote, US

As a pharmaceutical support industry leader , UBC is devoted to empowering health solutions for a better tomorrow . We take pride in improving patient outcomes and advancing healthcare. At UBC we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

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
• Very good knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)
• 10% travel as required

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
• Growth opportunities for promotion
• 401K with company match*
• Flexible work environment
• Discretionary PTO (Paid Time Off)
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision coverage
• HSA/FSA
• Wellness program
• Adoption assistance
• Short term disability
• Long term disability
• Life insurance

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.