REMS Project Manager

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 UBCwe 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
• 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

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.

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